Back to resultsStudy of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013) (MOVe-AHEAD)
Primary Purpose
Coronavirus Disease (COVID-19)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Molnupiravir
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Coronavirus Disease (COVID-19)
Eligibility Criteria
Inclusion Criteria:
- Lives in a household with an index case where the index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have 1) a first detectable SARS-CoV-2 test result from a sample collected within ≤5 days prior to randomization of the participant, and 2) at least 1 symptom attributable to COVID-19 (e.g., fever, difficulty breathing)
- Does not have confirmed or suspected COVID-19
- Is willing and able to take oral medication
- For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for ≥3 months after the last dose of study drug
- Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method), or is a WOCBP who is abstinent from heterosexual intercourse
Exclusion Criteria:
- Has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms) within 6 months prior to randomization
- Has either of the following: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL (regardless of CD4 count) or an acquired immunodeficiency syndrome (AIDS)-defining illness
- Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with any of the following: cirrhosis, end-stage liver disease, hepatocellular carcinoma; aspartate transaminase (AST) and/or (ALT) >3x upper limit of normal at screening
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to participants with conditions that could limit gastrointestinal absorption of capsule contents
- Has received, is taking, or is anticipated to require any prohibited therapies
- Has received a COVID-19 vaccination with the first dose ≥7 days prior to randomization
- Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics
- Is living in a household with >10 people
Sites / Locations
- Cahaba Research, Inc. ( Site 2523)
- The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2484)
- The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2448)
- Hope Clinical Research ( Site 2400)
- Carbon Health ( Site 2515)
- UCSF Fresno ( Site 2528)
- ASCADA Research, LLC ( Site 2516)
- Marvel Clinical Research ( Site 2490)
- National Research Institute ( Site 2452)
- Valley Clinical Trials Inc. ( Site 2406)
- Carbon Health ( Site 2514)
- University of California Davis ( Site 2497)
- Millennium Clinical Trials ( Site 2468)
- Future Innovative Treatments, LLC ( Site 2471)
- Emerson Clinical Research Institute ( Site 2457)
- Synergy Healthcare ( Site 2521)
- Accel Research Sites-DeLand Clinical Research Unit ( Site 2535)
- Velocity Clinical Research, Hallandale Beach ( Site 2485)
- Indago Research and Health Center Inc ( Site 2412)
- Advanced Research For Health Improvement LLC ( Site 2436)
- Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2508)
- CDC Research Institute, LLC ( Site 2540)
- Clinical Research Trials of Florida ( Site 2402)
- Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2425)
- Balanced Life Healthcare Solutions/SKYCRNG ( Site 2539)
- Chicago Clinical Research Institute Inc ( Site 2454)
- Rush University Medical Center ( Site 2510)
- Southern Clinical Research Associates ( Site 2542)
- MedPharmics, LLC ( Site 2443)
- Institute of Human Virology ( Site 2504)
- Centennial Medical Group ( Site 2435)
- Jadestone Clinical Research, LLC ( Site 2530)
- Michigan Center of Medical Research ( Site 2445)
- Michigan Center of Medical Research ( Site 2525)
- Allina Health Infectious Diseases Research Clinic ( Site 2507)
- Prime Health and Wellness/SKYCRNG ( Site 2538)
- Quinn Healthcare/Skycrng ( Site 2537)
- University of Missouri Hospital ( Site 2486)
- Mercury Street Medical Group PLLC ( Site 2476)
- University of Nebraska Medical Center ( Site 2430)
- Excel Clinical Research, LLC ( Site 2404)
- ID Care ( Site 2466)
- Amici Clinical Research LLC ( Site 2426)
- AXCES Research Group ( Site 2437)
- Montefiore Medical Center ( Site 2503)
- ECU Adult Specialty Care ( Site 2415)
- The Lindner Center for Research and Education at The Christ Hospital ( Site 2517)
- Dayton Clinical Research ( Site 2488)
- Cherokee Nation WW Hastings Indian Hospital/Cherokee Nation Health Services ( Site 2459)
- Preferred Clinical Research ( Site 2470)
- Velocity Clinical Research-Providence ( Site 2432)
- Tribe Clinical Research, LLC ( Site 2409)
- PharmaTex Research, LLC ( Site 2541)
- TTS Research ( Site 2433)
- Houston Methodist Hospital ( Site 2463)
- Santa Clara Family Clinic ( Site 2462)
- Crossroads Clinical Research LLC ( Site 2451)
- TPMG Clinical Research ( Site 2495)
- Covid-19 Clinical Research Center (CCRC) ( Site 2421)
- Sanatorio de la Trinidad Mitre ( Site 0108)
- Mautalen Salud e Investigacion ( Site 0103)
- Hospital Italiano de Buenos Aires ( Site 0102)
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0105)
- Clinica Independencia ( Site 0104)
- Grupo Oroño Centro medico San Nicolas ( Site 0109)
- Instituto Medico de la Fundacion Estudios Clinicos ( Site 0106)
- CEMIC ( Site 0101)
- Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0303)
- Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul - UFMS ( Site 0305)
- Hospital Nossa Senhora das Gracas ( Site 0310)
- Oncosite-Centro de Pesquisa Clinica em Oncologia ( Site 0300)
- Centro de Referência e Treinamento DST/AIDS ( Site 0301)
- Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0312)
- Centro de Referencia Professor Helio Fraga - FIOCRUZ/RJ ( Site 0314)
- Medical Center Hera EOOD ( Site 3001)
- Medical Center Hera Kyustendi EOOD ( Site 3003)
- Medical Center Hera EOOD - Montana branch ( Site 3002)
- Fundacion Centro de Investigacion Clinica CIC ( Site 0402)
- Centro Cientifico Asistencial Jose Luis Accini ( Site 0412)
- Clinica de la Costa Ltda. ( Site 0407)
- Oncomedica S.A. ( Site 0406)
- Hospital Universitario Clinica San Rafael ( Site 0410)
- Healthy Medical Center S.A.S ( Site 0413)
- Caja de Compensacion Familiar CAFAM ( Site 0403)
- Fundacion Centro de Investigaciones Clinicas CARDIOMET ( Site 0409)
- Instituto Neumologico del Oriente S.A. ( Site 0408)
- Fundacion Valle del Lili ( Site 0405)
- Unidad de Aislamiento del Centro de Obstetricia y Ginecologia ( Site 2650)
- National Center for allergies and chest ( Site 2940)
- Imbaba Fevers Hospital ( Site 2945)
- Masri - CRC - Ain Shams University ( Site 2900)
- Masri - CRC - Ain Shams University ( Site 2910)
- National Hepatology and Tropical Medicine Research Institute ( Site 2930)
- Air Force Specialized Hospital Clinical Research Center ( Site 2920)
- Maison de Sante Universitaire La Providence ( Site 0506)
- Hôpital Pitié - Salpêtrière ( Site 0501)
- CHU de la Reunion - Groupe Hospitalier Sud ( Site 0508)
- CHU Martinique ( Site 0511)
- Maison de santé du Pays Neufchatelois ( Site 0507)
- Centro de Investigaciones Pediatricas ( Site 0703)
- Unidad de Diagnostico Cardiologico ( Site 0701)
- Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0702)
- Clinica Privada ( Site 0705)
- Private Clinic - Dr. Hugo Pezzarossi ( Site 0704)
- LONA MEDIC Kft ( Site 0804)
- Debreceni Egyetem Klinikai Kozpont- Infektologiai Klinika ( Site 0824)
- Bugat Pal Korhaz ( Site 0817)
- Medifarma-98 Kft. ( Site 0808)
- DRC Gyogyszervizsgalo Kozpont Kft. ( Site 0801)
- Obudai Egeszsegugyi Centrum - OEC ( Site 0821)
- Strazsahegy Medicina Bt ( Site 0823)
- Obudai Egeszsegugyi Centrum - Zalaegerszeg ( Site 0819)
- IUHW Narita Hospital ( Site 1105)
- National Hospital Organization Okinawa National Hospital ( Site 1109)
- Social Medical Corporation Yuuaikai Yuuai Medical Center ( Site 1108)
- Chiba Aoba Municipal Hospital ( Site 1100)
- Global Healthcare Clinic ( Site 1106)
- Den-en-chofu family clinic ( Site 1104)
- Center Hospital of the National Center for Global Health and Medicine ( Site 1101)
- Sekino Hospital ( Site 1110)
- Center for Clinical Research (CCR) KEMRI ( Site 1929)
- Partners in Health Research and Development PHRD ( Site 1928)
- KEMRI-CMR-RCTP- Kenya Medical Research Institute Kisumu ( Site 1925)
- Hospital Raja Perempuan Zainab II ( Site 2851)
- Klinik Kesihatan Masjid Tanah ( Site 2850)
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1308)
- Morales Vargas Centro de Investigacion, S.C. ( Site 1318)
- Hospital General de Acapulco ( Site 1319)
- Instituto Jalisciense de Metabolismo SC ( Site 1314)
- Centro Médico Universitario ( Site 1316)
- CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 1315)
- Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 1301)
- Köhler & Milstein Research S.A. de C.V. ( Site 1300)
- Centro de Investigacion Medica Aguascalientes ( Site 1305)
- ICARO Investigaciones en Medicina ( Site 1313)
- Medica Sur S.A.B de C.V. ( Site 1303)
- Oaxaca Site Management Organization S.C. ( Site 1304)
- Arké SMO S.A de C.V ( Site 1306)
- Policlínico Especializado en Neurología - Unid. Inv. Neurológica ( Site 1403)
- Clínica Ricardo Palma ( Site 1406)
- Asociacion Civil por la Salud ( Site 1411)
- Investigaciones Medicas en Salud - INMENSA ( Site 1401)
- Asociacion Civil IMPACTA Salud y Educacion - Sede San Miguel ( Site 1410)
- Clinica Providencia ( Site 1400)
- Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1404)
- Asian Hospital and Medical Center ( Site 1503)
- Quirino Memorial Medical Center ( Site 1501)
- Health Index Multi-Specialty and Lying -in Clinic ( Site 1504)
- Centrul Medical Unirea SRL Bucuresti ( Site 1706)
- Centrul Medical Unirea SRL ( Site 1707)
- S.C Materna Care SRL ( Site 1702)
- Centrul Medical Unirea ( Site 1705)
- Delta Heath Care S.R.L ( Site 1708)
- SC Policlinica CCBR SRL. Bucuresti ( Site 1704)
- Centrul Medical Unirea SRL Constanta ( Site 1703)
- Centrul Medical Unirea SRL IASI ( Site 1701)
- FSBI Central Hospital with Policlinics ( Site 1807)
- Infectious Clinical Hospital # 1 ( Site 1834)
- SPb SBHI City outpatient clinic 112 ( Site 1829)
- Smorodintsev Research Institute of Influenza ( Site 1833)
- Nikolaevskaya hospital ( Site 1810)
- SPb SBHI City outpatient clinic 4 ( Site 1831)
- Limited liability company "Scientific research center Eco-safety" ( Site 1809)
- City Polyclinic #88 ( Site 1808)
- LLC -Medical Center . Capital-Polis ( Site 1825)
- St.Petersburg Outpatient Clinic No. 109 ( Site 1818)
- SPb SBHI. City outpatient clinic No.44 ( Site 1830)
- Medical Research Institute LLC. ( Site 1814)
- Smolensk State Medical Academy ( Site 1803)
- Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1802)
- Voronezh Regional Clinical Hospital #1 ( Site 1823)
- LLC -Clinic of modern medicine of Doctor Bogorodskaya ( Site 1828)
- IATROS International ( Site 1921)
- REIMED Reiger Park ( Site 1910)
- Midrand Medical Centre ( Site 1913)
- Wits Health Consortium. Clinical HIV Research Unit ( Site 1923)
- Right To Care Research - Esizayo ( Site 1907)
- DJW Navorsing ( Site 1915)
- Zinakekele Medical Centre ( Site 1926)
- Mzansi Ethical Research Centre ( Site 1918)
- Jongaie Research ( Site 1900)
- Global Clinical Trial Centre ( Site 1904)
- Dr Jugnundun & Partners ( Site 1905)
- Enhancing Care Foundation-DICRS ( Site 1922)
- Private Practice - Dr. Neyaseelan Gounden ( Site 1911)
- Limpopo Clinical Research Initiative ( Site 1901)
- TASK Applied Science ( Site 1920)
- DTHF Masiphumelele Clinical Research Site ( Site 1919)
- Be Part Yoluntu Centre ( Site 1914)
- Paarl Research Centre ( Site 1924)
- Hospital Universitari Germans Trias i Pujol ( Site 2010)
- CAP Centelles ( Site 2011)
- Hospital de Alcorcon ( Site 2003)
- C.S. Vallcarca-Sant Gervasi ( Site 2000)
- CAP de Sardenya ( Site 2009)
- Hospital Universitario Infanta Leonor ( Site 2002)
- Hospital Universitario La Paz ( Site 2024)
- HIV-NAT AIDS Research Centre ( Site 2804)
- Chulabhorn Hospital ( Site 2801)
- Rajavithi Hospital ( Site 2803)
- The Golden Jubilee Medical Center ( Site 2800)
- Songklanagarind Hospital ( Site 2802)
- Atakent Acibadem Hastanesi ( Site 2103)
- Sancaktepe Prof Dr Ilhan Varank EAH-Prof Dr Feriha Oz Hastanesi ( Site 2113)
- Ankara Universitesi Ibni Sina Hastanesi ( Site 2101)
- Hacettepe Universitesi Tip Fakultesi ( Site 2102)
- Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2106)
- Ankara Sehir Hastanesi ( Site 2111)
- Istanbul Universitesi Istanbul Tip Fakultesi ( Site 2110)
- Medipol Universite Hastanesi ( Site 2108)
- Basaksehir Cam ve Sakura City Hospital ( Site 2112)
- Ege Universitesi Tip Fakultesi Hastanesi ( Site 2105)
- Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2107)
- Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 2232)
- Regional Phthisiopulmonological Center ( Site 2203)
- NPME -Central Clinical Hospital of Ivano-Frankivsk City Council ( Site 2204)
- Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 2229)
- PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 2201)
- Limited Liability Company Medical center Healthy Happy ( Site 2225)
- MNPE Consultative-Diagnostic Centre of Desnyanskyi District of Kyiv ( Site 2205)
- Kyiv railway clinical hospital 2 of Branch Health center ( Site 2207)
- Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 2200)
- Odesa Regional Center of Socially Significant Diseases ( Site 2230)
- MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 2226)
- Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 2227)
- Medical Clinical Investigational Center of Medical Center Health Clinic ( Site 2210)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Molnupiravir
Placebo
Arm Description
Participants take molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
Participants take placebo Q12H on Days 1 to 5.
Outcomes
Primary Outcome Measures
Percentage of participants who have undetectable SARS-CoV-2 in baseline nasopharyngeal (NP) swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14
Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2) infection with symptoms) through Day 14.
Percentage of participants with ≥1 adverse event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of participants discontinuing from study therapy due to AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Secondary Outcome Measures
Percentage of participants (regardless of SARS-CoV-2 in baseline NP swabs) who develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14
Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have NP swabs tested for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).
Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 29
Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have NP swabs tested for SARS-CoV-2 using RT-PCR.
Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop detectable SARS-CoV-2 in NP swabs on or before Day 14
All participants will have NP swabs collected at screening and through Day 14 to test for SARS-CoV-2 using RT-PCR.
Percentage of participants who have detectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14
Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have NP swabs tested for SARS-CoV-2 using RT-PCR.
Full Information
NCT ID
NCT04939428
First Posted
June 24, 2021
Last Updated
December 5, 2022
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04939428
Brief Title
Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)
Acronym
MOVe-AHEAD
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
November 16, 2022 (Actual)
Study Completion Date
November 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease (COVID-19)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1539 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Molnupiravir
Arm Type
Experimental
Arm Description
Participants take molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants take placebo Q12H on Days 1 to 5.
Intervention Type
Drug
Intervention Name(s)
Molnupiravir
Other Intervention Name(s)
MK-4482
Intervention Description
Four molnupiravir 200 mg capsules taken by mouth.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.
Primary Outcome Measure Information:
Title
Percentage of participants who have undetectable SARS-CoV-2 in baseline nasopharyngeal (NP) swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14
Description
Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2) infection with symptoms) through Day 14.
Time Frame
Up to Day 14
Title
Percentage of participants with ≥1 adverse event
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Up to 29 days
Title
Percentage of participants discontinuing from study therapy due to AE
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Up to 5 days
Secondary Outcome Measure Information:
Title
Percentage of participants (regardless of SARS-CoV-2 in baseline NP swabs) who develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14
Description
Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have NP swabs tested for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).
Time Frame
Up to Day 14
Title
Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 29
Description
Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have NP swabs tested for SARS-CoV-2 using RT-PCR.
Time Frame
Up to Day 29
Title
Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop detectable SARS-CoV-2 in NP swabs on or before Day 14
Description
All participants will have NP swabs collected at screening and through Day 14 to test for SARS-CoV-2 using RT-PCR.
Time Frame
Up to Day 14
Title
Percentage of participants who have detectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14
Description
Participants who experience targeted symptoms of COVID-19 (e.g., cough, sore throat) will have NP swabs tested for SARS-CoV-2 using RT-PCR.
Time Frame
Up to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Lives in a household with an index case where the index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have 1) a first detectable SARS-CoV-2 test result from a sample collected within ≤5 days prior to randomization of the participant, and 2) at least 1 symptom attributable to COVID-19 (e.g., fever, difficulty breathing)
Does not have confirmed or suspected COVID-19
Is willing and able to take oral medication
For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for ≥3 months after the last dose of study drug
Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method), or is a WOCBP who is abstinent from heterosexual intercourse
Exclusion Criteria:
Has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms) within 6 months prior to randomization
Has either of the following: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL (regardless of CD4 count) or an acquired immunodeficiency syndrome (AIDS)-defining illness
Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with any of the following: cirrhosis, end-stage liver disease, hepatocellular carcinoma; aspartate transaminase (AST) and/or (ALT) >3x upper limit of normal at screening
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to participants with conditions that could limit gastrointestinal absorption of capsule contents
Has received, is taking, or is anticipated to require any prohibited therapies
Has received a COVID-19 vaccination with the first dose ≥7 days prior to randomization
Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics
Is living in a household with >10 people
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Research, Inc. ( Site 2523)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2484)
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2448)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Hope Clinical Research ( Site 2400)
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Carbon Health ( Site 2515)
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
UCSF Fresno ( Site 2528)
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
ASCADA Research, LLC ( Site 2516)
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Marvel Clinical Research ( Site 2490)
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
National Research Institute ( Site 2452)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Valley Clinical Trials Inc. ( Site 2406)
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Carbon Health ( Site 2514)
City
Oakland
State/Province
California
ZIP/Postal Code
94610
Country
United States
Facility Name
University of California Davis ( Site 2497)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Millennium Clinical Trials ( Site 2468)
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Future Innovative Treatments, LLC ( Site 2471)
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Emerson Clinical Research Institute ( Site 2457)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Synergy Healthcare ( Site 2521)
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Accel Research Sites-DeLand Clinical Research Unit ( Site 2535)
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Velocity Clinical Research, Hallandale Beach ( Site 2485)
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Indago Research and Health Center Inc ( Site 2412)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Advanced Research For Health Improvement LLC ( Site 2436)
City
Immokalee
State/Province
Florida
ZIP/Postal Code
34142
Country
United States
Facility Name
Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2508)
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
CDC Research Institute, LLC ( Site 2540)
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Clinical Research Trials of Florida ( Site 2402)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2425)
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Balanced Life Healthcare Solutions/SKYCRNG ( Site 2539)
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Chicago Clinical Research Institute Inc ( Site 2454)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Rush University Medical Center ( Site 2510)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Southern Clinical Research Associates ( Site 2542)
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
MedPharmics, LLC ( Site 2443)
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Institute of Human Virology ( Site 2504)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Centennial Medical Group ( Site 2435)
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Jadestone Clinical Research, LLC ( Site 2530)
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
Michigan Center of Medical Research ( Site 2445)
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Michigan Center of Medical Research ( Site 2525)
City
Lathrup Village
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Facility Name
Allina Health Infectious Diseases Research Clinic ( Site 2507)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Prime Health and Wellness/SKYCRNG ( Site 2538)
City
Fayette
State/Province
Mississippi
ZIP/Postal Code
39069
Country
United States
Facility Name
Quinn Healthcare/Skycrng ( Site 2537)
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
University of Missouri Hospital ( Site 2486)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Mercury Street Medical Group PLLC ( Site 2476)
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
University of Nebraska Medical Center ( Site 2430)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3135
Country
United States
Facility Name
Excel Clinical Research, LLC ( Site 2404)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
ID Care ( Site 2466)
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Amici Clinical Research LLC ( Site 2426)
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Facility Name
AXCES Research Group ( Site 2437)
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Montefiore Medical Center ( Site 2503)
City
Bronx
State/Province
New York
ZIP/Postal Code
10462
Country
United States
Facility Name
ECU Adult Specialty Care ( Site 2415)
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
The Lindner Center for Research and Education at The Christ Hospital ( Site 2517)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Dayton Clinical Research ( Site 2488)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Cherokee Nation WW Hastings Indian Hospital/Cherokee Nation Health Services ( Site 2459)
City
Tahlequah
State/Province
Oklahoma
ZIP/Postal Code
74464
Country
United States
Facility Name
Preferred Clinical Research ( Site 2470)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Velocity Clinical Research-Providence ( Site 2432)
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Tribe Clinical Research, LLC ( Site 2409)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
PharmaTex Research, LLC ( Site 2541)
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
Facility Name
TTS Research ( Site 2433)
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Houston Methodist Hospital ( Site 2463)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Santa Clara Family Clinic ( Site 2462)
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Facility Name
Crossroads Clinical Research LLC ( Site 2451)
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
TPMG Clinical Research ( Site 2495)
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23188
Country
United States
Facility Name
Covid-19 Clinical Research Center (CCRC) ( Site 2421)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Sanatorio de la Trinidad Mitre ( Site 0108)
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
Facility Name
Mautalen Salud e Investigacion ( Site 0103)
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires ( Site 0102)
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0105)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZO
Country
Argentina
Facility Name
Clinica Independencia ( Site 0104)
City
Munro
State/Province
Buenos Aires
ZIP/Postal Code
B1605FRE
Country
Argentina
Facility Name
Grupo Oroño Centro medico San Nicolas ( Site 0109)
City
San Nicolas
State/Province
Buenos Aires
ZIP/Postal Code
B2900DPA
Country
Argentina
Facility Name
Instituto Medico de la Fundacion Estudios Clinicos ( Site 0106)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
CEMIC ( Site 0101)
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0303)
City
Manaus
State/Province
Amazonas
ZIP/Postal Code
69040-000
Country
Brazil
Facility Name
Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul - UFMS ( Site 0305)
City
Campo Grande
State/Province
Mato Grosso Do Sul
ZIP/Postal Code
79070-900
Country
Brazil
Facility Name
Hospital Nossa Senhora das Gracas ( Site 0310)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Oncosite-Centro de Pesquisa Clinica em Oncologia ( Site 0300)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Centro de Referência e Treinamento DST/AIDS ( Site 0301)
City
Sao Paoulo
State/Province
Sao Paulo
ZIP/Postal Code
04121-000
Country
Brazil
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0312)
City
São José do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090000
Country
Brazil
Facility Name
Centro de Referencia Professor Helio Fraga - FIOCRUZ/RJ ( Site 0314)
City
Rio de Janeiro
ZIP/Postal Code
22780-192
Country
Brazil
Facility Name
Medical Center Hera EOOD ( Site 3001)
City
Sofia
State/Province
Sofia (stolitsa)
ZIP/Postal Code
1510
Country
Bulgaria
Facility Name
Medical Center Hera Kyustendi EOOD ( Site 3003)
City
Kyustendil
ZIP/Postal Code
2500
Country
Bulgaria
Facility Name
Medical Center Hera EOOD - Montana branch ( Site 3002)
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
Fundacion Centro de Investigacion Clinica CIC ( Site 0402)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050021
Country
Colombia
Facility Name
Centro Cientifico Asistencial Jose Luis Accini ( Site 0412)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Clinica de la Costa Ltda. ( Site 0407)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Oncomedica S.A. ( Site 0406)
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Hospital Universitario Clinica San Rafael ( Site 0410)
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110411
Country
Colombia
Facility Name
Healthy Medical Center S.A.S ( Site 0413)
City
Zipaquira
State/Province
Cundinamarca
ZIP/Postal Code
250252
Country
Colombia
Facility Name
Caja de Compensacion Familiar CAFAM ( Site 0403)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111211
Country
Colombia
Facility Name
Fundacion Centro de Investigaciones Clinicas CARDIOMET ( Site 0409)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660003
Country
Colombia
Facility Name
Instituto Neumologico del Oriente S.A. ( Site 0408)
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
681004
Country
Colombia
Facility Name
Fundacion Valle del Lili ( Site 0405)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Unidad de Aislamiento del Centro de Obstetricia y Ginecologia ( Site 2650)
City
Santo Domingo
State/Province
Distrito Nacional
ZIP/Postal Code
10605
Country
Dominican Republic
Facility Name
National Center for allergies and chest ( Site 2940)
City
Giza
State/Province
Al Jizah
ZIP/Postal Code
12651
Country
Egypt
Facility Name
Imbaba Fevers Hospital ( Site 2945)
City
Giza
State/Province
Al Jizah
ZIP/Postal Code
12661
Country
Egypt
Facility Name
Masri - CRC - Ain Shams University ( Site 2900)
City
Cairo
State/Province
Al Qahirah
ZIP/Postal Code
11566
Country
Egypt
Facility Name
Masri - CRC - Ain Shams University ( Site 2910)
City
Cairo
State/Province
Al Qahirah
ZIP/Postal Code
11566
Country
Egypt
Facility Name
National Hepatology and Tropical Medicine Research Institute ( Site 2930)
City
Cairo
State/Province
Al Qahirah
ZIP/Postal Code
11796
Country
Egypt
Facility Name
Air Force Specialized Hospital Clinical Research Center ( Site 2920)
City
Cairo
State/Province
Al Qahirah
ZIP/Postal Code
11835
Country
Egypt
Facility Name
Maison de Sante Universitaire La Providence ( Site 0506)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31500
Country
France
Facility Name
Hôpital Pitié - Salpêtrière ( Site 0501)
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75013
Country
France
Facility Name
CHU de la Reunion - Groupe Hospitalier Sud ( Site 0508)
City
Saint Pierre Cedex
State/Province
La Reunion
ZIP/Postal Code
97448
Country
France
Facility Name
CHU Martinique ( Site 0511)
City
Fort De France
State/Province
Martinique
ZIP/Postal Code
97200
Country
France
Facility Name
Maison de santé du Pays Neufchatelois ( Site 0507)
City
Neufchatel-en-Bray
State/Province
Seine-Maritime
ZIP/Postal Code
76270
Country
France
Facility Name
Centro de Investigaciones Pediatricas ( Site 0703)
City
Guatemala
ZIP/Postal Code
01001
Country
Guatemala
Facility Name
Unidad de Diagnostico Cardiologico ( Site 0701)
City
Guatemala
ZIP/Postal Code
01001
Country
Guatemala
Facility Name
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0702)
City
Guatemala
ZIP/Postal Code
01009
Country
Guatemala
Facility Name
Clinica Privada ( Site 0705)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Private Clinic - Dr. Hugo Pezzarossi ( Site 0704)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
LONA MEDIC Kft ( Site 0804)
City
Oroshaza
State/Province
Bekes
ZIP/Postal Code
5900
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont- Infektologiai Klinika ( Site 0824)
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Bugat Pal Korhaz ( Site 0817)
City
Gyongyos
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Medifarma-98 Kft. ( Site 0808)
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft. ( Site 0801)
City
Balatonfured
State/Province
Veszprem
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum - OEC ( Site 0821)
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Strazsahegy Medicina Bt ( Site 0823)
City
Budapest
ZIP/Postal Code
1171
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum - Zalaegerszeg ( Site 0819)
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
IUHW Narita Hospital ( Site 1105)
City
Narita
State/Province
Chiba
ZIP/Postal Code
286-8520
Country
Japan
Facility Name
National Hospital Organization Okinawa National Hospital ( Site 1109)
City
Ginowan
State/Province
Okinawa
ZIP/Postal Code
901-2214
Country
Japan
Facility Name
Social Medical Corporation Yuuaikai Yuuai Medical Center ( Site 1108)
City
Tomigusuku
State/Province
Okinawa
ZIP/Postal Code
901-0224
Country
Japan
Facility Name
Chiba Aoba Municipal Hospital ( Site 1100)
City
Chiba
ZIP/Postal Code
260-0852
Country
Japan
Facility Name
Global Healthcare Clinic ( Site 1106)
City
Tokyo
ZIP/Postal Code
102-0083
Country
Japan
Facility Name
Den-en-chofu family clinic ( Site 1104)
City
Tokyo
ZIP/Postal Code
145-0071
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine ( Site 1101)
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Sekino Hospital ( Site 1110)
City
Tokyo
ZIP/Postal Code
171-0014
Country
Japan
Facility Name
Center for Clinical Research (CCR) KEMRI ( Site 1929)
City
Nairobi
State/Province
Nairobi City
ZIP/Postal Code
00200
Country
Kenya
Facility Name
Partners in Health Research and Development PHRD ( Site 1928)
City
Nairobi
State/Province
Nairobi City
ZIP/Postal Code
00202
Country
Kenya
Facility Name
KEMRI-CMR-RCTP- Kenya Medical Research Institute Kisumu ( Site 1925)
City
Kisumu
ZIP/Postal Code
40100
Country
Kenya
Facility Name
Hospital Raja Perempuan Zainab II ( Site 2851)
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
Facility Name
Klinik Kesihatan Masjid Tanah ( Site 2850)
City
Masjid Tanah
State/Province
Melaka
ZIP/Postal Code
78300
Country
Malaysia
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1308)
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Morales Vargas Centro de Investigacion, S.C. ( Site 1318)
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Hospital General de Acapulco ( Site 1319)
City
Acapulco
State/Province
Guerrero
ZIP/Postal Code
39570
Country
Mexico
Facility Name
Instituto Jalisciense de Metabolismo SC ( Site 1314)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Centro Médico Universitario ( Site 1316)
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62210
Country
Mexico
Facility Name
CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 1315)
City
Gral Escobedo
State/Province
Nuevo Leon
ZIP/Postal Code
66055
Country
Mexico
Facility Name
Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 1301)
City
Cancun
State/Province
Quintana Roo
ZIP/Postal Code
77500
Country
Mexico
Facility Name
Köhler & Milstein Research S.A. de C.V. ( Site 1300)
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Centro de Investigacion Medica Aguascalientes ( Site 1305)
City
Aguascalientes
ZIP/Postal Code
20116
Country
Mexico
Facility Name
ICARO Investigaciones en Medicina ( Site 1313)
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Medica Sur S.A.B de C.V. ( Site 1303)
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Oaxaca Site Management Organization S.C. ( Site 1304)
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Arké SMO S.A de C.V ( Site 1306)
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Policlínico Especializado en Neurología - Unid. Inv. Neurológica ( Site 1403)
City
La Perla
State/Province
Qallaw
ZIP/Postal Code
07011
Country
Peru
Facility Name
Clínica Ricardo Palma ( Site 1406)
City
Lima
ZIP/Postal Code
15036
Country
Peru
Facility Name
Asociacion Civil por la Salud ( Site 1411)
City
Lima
ZIP/Postal Code
15046
Country
Peru
Facility Name
Investigaciones Medicas en Salud - INMENSA ( Site 1401)
City
Lima
ZIP/Postal Code
15046
Country
Peru
Facility Name
Asociacion Civil IMPACTA Salud y Educacion - Sede San Miguel ( Site 1410)
City
Lima
ZIP/Postal Code
15088
Country
Peru
Facility Name
Clinica Providencia ( Site 1400)
City
Lima
ZIP/Postal Code
15088
Country
Peru
Facility Name
Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1404)
City
Lima
ZIP/Postal Code
15423
Country
Peru
Facility Name
Asian Hospital and Medical Center ( Site 1503)
City
Muntinlupa
State/Province
National Capital Region
ZIP/Postal Code
1780
Country
Philippines
Facility Name
Quirino Memorial Medical Center ( Site 1501)
City
Quezon City
State/Province
National Capital Region
ZIP/Postal Code
1109
Country
Philippines
Facility Name
Health Index Multi-Specialty and Lying -in Clinic ( Site 1504)
City
Cavite
ZIP/Postal Code
4102
Country
Philippines
Facility Name
Centrul Medical Unirea SRL Bucuresti ( Site 1706)
City
Bucaresti
State/Province
Bucuresti
ZIP/Postal Code
011601
Country
Romania
Facility Name
Centrul Medical Unirea SRL ( Site 1707)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400349
Country
Romania
Facility Name
S.C Materna Care SRL ( Site 1702)
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300645
Country
Romania
Facility Name
Centrul Medical Unirea ( Site 1705)
City
Brasov
ZIP/Postal Code
500091
Country
Romania
Facility Name
Delta Heath Care S.R.L ( Site 1708)
City
Bucuresti
ZIP/Postal Code
014142
Country
Romania
Facility Name
SC Policlinica CCBR SRL. Bucuresti ( Site 1704)
City
Bucuresti
ZIP/Postal Code
030463
Country
Romania
Facility Name
Centrul Medical Unirea SRL Constanta ( Site 1703)
City
Constanta
ZIP/Postal Code
900540
Country
Romania
Facility Name
Centrul Medical Unirea SRL IASI ( Site 1701)
City
Iasi
ZIP/Postal Code
700023
Country
Romania
Facility Name
FSBI Central Hospital with Policlinics ( Site 1807)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Infectious Clinical Hospital # 1 ( Site 1834)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125310
Country
Russian Federation
Facility Name
SPb SBHI City outpatient clinic 112 ( Site 1829)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
195427
Country
Russian Federation
Facility Name
Smorodintsev Research Institute of Influenza ( Site 1833)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Nikolaevskaya hospital ( Site 1810)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198510
Country
Russian Federation
Facility Name
SPb SBHI City outpatient clinic 4 ( Site 1831)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
199406
Country
Russian Federation
Facility Name
Limited liability company "Scientific research center Eco-safety" ( Site 1809)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
City Polyclinic #88 ( Site 1808)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198261
Country
Russian Federation
Facility Name
LLC -Medical Center . Capital-Polis ( Site 1825)
City
Saint-Petrsburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
190013
Country
Russian Federation
Facility Name
St.Petersburg Outpatient Clinic No. 109 ( Site 1818)
City
Saint-Petrsburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
192289
Country
Russian Federation
Facility Name
SPb SBHI. City outpatient clinic No.44 ( Site 1830)
City
St.Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
192071
Country
Russian Federation
Facility Name
Medical Research Institute LLC. ( Site 1814)
City
St.Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Smolensk State Medical Academy ( Site 1803)
City
Smolensk
State/Province
Smolenskaya Oblast
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1802)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420140
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Hospital #1 ( Site 1823)
City
Voronezh
State/Province
Voronezskaja Oblast
ZIP/Postal Code
394066
Country
Russian Federation
Facility Name
LLC -Clinic of modern medicine of Doctor Bogorodskaya ( Site 1828)
City
Yaroslavl
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150001
Country
Russian Federation
Facility Name
IATROS International ( Site 1921)
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9300
Country
South Africa
Facility Name
REIMED Reiger Park ( Site 1910)
City
Boksburg
State/Province
Gauteng
ZIP/Postal Code
1459
Country
South Africa
Facility Name
Midrand Medical Centre ( Site 1913)
City
Halfway House, Midrand
State/Province
Gauteng
ZIP/Postal Code
1685
Country
South Africa
Facility Name
Wits Health Consortium. Clinical HIV Research Unit ( Site 1923)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2041
Country
South Africa
Facility Name
Right To Care Research - Esizayo ( Site 1907)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2087
Country
South Africa
Facility Name
DJW Navorsing ( Site 1915)
City
Krugersdorp
State/Province
Gauteng
ZIP/Postal Code
1739
Country
South Africa
Facility Name
Zinakekele Medical Centre ( Site 1926)
City
Moloto
State/Province
Gauteng
ZIP/Postal Code
1022
Country
South Africa
Facility Name
Mzansi Ethical Research Centre ( Site 1918)
City
Mpumalanga
State/Province
Gauteng
ZIP/Postal Code
1055
Country
South Africa
Facility Name
Jongaie Research ( Site 1900)
City
Pretoria-West
State/Province
Gauteng
ZIP/Postal Code
0183
Country
South Africa
Facility Name
Global Clinical Trial Centre ( Site 1904)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0186
Country
South Africa
Facility Name
Dr Jugnundun & Partners ( Site 1905)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Enhancing Care Foundation-DICRS ( Site 1922)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Private Practice - Dr. Neyaseelan Gounden ( Site 1911)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4093
Country
South Africa
Facility Name
Limpopo Clinical Research Initiative ( Site 1901)
City
Thabazimbi
State/Province
Limpopo
ZIP/Postal Code
0380
Country
South Africa
Facility Name
TASK Applied Science ( Site 1920)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
DTHF Masiphumelele Clinical Research Site ( Site 1919)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7975
Country
South Africa
Facility Name
Be Part Yoluntu Centre ( Site 1914)
City
Paarl
State/Province
Western Cape
ZIP/Postal Code
7626
Country
South Africa
Facility Name
Paarl Research Centre ( Site 1924)
City
Paarl
State/Province
Western Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Hospital Universitari Germans Trias i Pujol ( Site 2010)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
CAP Centelles ( Site 2011)
City
Centelles
State/Province
Barcelona
ZIP/Postal Code
08540
Country
Spain
Facility Name
Hospital de Alcorcon ( Site 2003)
City
Alcorcon
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28922
Country
Spain
Facility Name
C.S. Vallcarca-Sant Gervasi ( Site 2000)
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
CAP de Sardenya ( Site 2009)
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor ( Site 2002)
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario La Paz ( Site 2024)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
HIV-NAT AIDS Research Centre ( Site 2804)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Chulabhorn Hospital ( Site 2801)
City
Lak Si
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10210
Country
Thailand
Facility Name
Rajavithi Hospital ( Site 2803)
City
Ratchathewi
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Facility Name
The Golden Jubilee Medical Center ( Site 2800)
City
Phutthamonthon
State/Province
Nakhon Pathom
ZIP/Postal Code
73170
Country
Thailand
Facility Name
Songklanagarind Hospital ( Site 2802)
City
Hat-Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Atakent Acibadem Hastanesi ( Site 2103)
City
Halkali/K.cekmece
State/Province
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Sancaktepe Prof Dr Ilhan Varank EAH-Prof Dr Feriha Oz Hastanesi ( Site 2113)
City
Istabul
State/Province
Istanbul
ZIP/Postal Code
34785
Country
Turkey
Facility Name
Ankara Universitesi Ibni Sina Hastanesi ( Site 2101)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi ( Site 2102)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2106)
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Ankara Sehir Hastanesi ( Site 2111)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi ( Site 2110)
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Medipol Universite Hastanesi ( Site 2108)
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Basaksehir Cam ve Sakura City Hospital ( Site 2112)
City
Istanbul
ZIP/Postal Code
34494
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2105)
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2107)
City
Sakarya
ZIP/Postal Code
54100
Country
Turkey
Facility Name
Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 2232)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76007
Country
Ukraine
Facility Name
Regional Phthisiopulmonological Center ( Site 2203)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
NPME -Central Clinical Hospital of Ivano-Frankivsk City Council ( Site 2204)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76025
Country
Ukraine
Facility Name
Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 2229)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 2201)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61172
Country
Ukraine
Facility Name
Limited Liability Company Medical center Healthy Happy ( Site 2225)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
01033
Country
Ukraine
Facility Name
MNPE Consultative-Diagnostic Centre of Desnyanskyi District of Kyiv ( Site 2205)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
02232
Country
Ukraine
Facility Name
Kyiv railway clinical hospital 2 of Branch Health center ( Site 2207)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 2200)
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79011
Country
Ukraine
Facility Name
Odesa Regional Center of Socially Significant Diseases ( Site 2230)
City
Odesa
State/Province
Odeska Oblast
ZIP/Postal Code
65014
Country
Ukraine
Facility Name
MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 2226)
City
Odessa
State/Province
Odeska Oblast
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 2227)
City
Poltava
State/Province
Poltavska Oblast
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Medical Clinical Investigational Center of Medical Center Health Clinic ( Site 2210)
City
Vinnytsia
State/Province
Vinnytska Oblast
ZIP/Postal Code
21009
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)
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