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Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19 (MORNINGSKY)

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RO7496998
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus Disease 2019; COVID-19; antiviral drug; SARS-CoV-2; Mild to Moderate COVID-19; antiviral efficacy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) ≤72 hours prior to randomization
  • At least three of the following symptoms of at least moderate (score ≥2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea.
  • Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days before dosing on Day 1

Exclusion Criteria:

  • Clinical signs indicative of COVID-19 illness requiring hospitalization
  • Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19
  • In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization
  • Treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization
  • Treatment with a COVID-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against SARS-CoV-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2 or interleukin 6 (IL-6), intravenous immunoglobulin or other EUA-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit
  • Concomitant use of P-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol
  • Known allergy or hypersensitivity to components of study drug
  • Abnormal laboratory test results at screening
  • Requirement of any prohibited medications during the study
  • Other known active viral or bacterial infection at the time of screening, such as influenza
  • Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study
  • COVID-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)

Sites / Locations

  • Instituto Medico Rio Cuarto
  • Instituto Ave Pulmo
  • Clínica Independencia
  • Instituto Medico de la Fundacion Estudios Clinicos
  • Clinica Mayo de U.M.C.B. S.R.L
  • Sanatorio Medico de Diagnostico Y Tratamiento
  • Maison Médicale La Brèche
  • Private Practice Dr Jean Benoit Martinot
  • Medif
  • L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar
  • Chronos Pesquisa Clinica
  • Hospital das Clinicas - UFMG
  • Hospital Agamenon Magalhães
  • Hospital Nossa Senhora das Graças
  • Hospital Erasto Gaertner
  • Hospital E Maternidade Celso Pierro PUCCAMP
  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
  • CPQuali Pesquisa Clínica Sao Paulo
  • Institute of Infectious Diseases Emilio Ribas
  • Conjunto Hospitalar do Mandaqui
  • Healthy Medical Center SAS
  • Aalborg Universitetshospital
  • Rigshospitalet Copenhagen University Hospital
  • Sjællands Universitetshospital, Roskilde
  • Centre Hospitalier Victor Dupouy
  • Hôpital Saint Joseph
  • Hopital Tenon
  • Klinikum Chemnitz gGmbH
  • Universitätsklinikum Frankfurt
  • Universitätsklinikum Freiburg
  • Praxis am Ebertplatz
  • ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco
  • Ospedale San Raffaele S.r.l.
  • Comprensorio Amedeo Di Savoia Birago Di Vische
  • Funabashi Central Hospital
  • Higashiosaka city Medical Center
  • Rinku General Medical Center
  • Sagamihara Kyodo Hospital
  • Misyuku hospital
  • Nagoya City East Medical Center
  • Fujita Health University Banbuntane Hotokukai Hospital
  • Tokyo Metropolitan Police Hospital
  • IUHW Narita Hospital
  • Houjin Syadan Kouhoukai Takagi Hospital
  • Okayama City Hospital
  • Ome Municipal General Hospital
  • Osaka City General Hospital
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
  • St. Luke's International Hospital
  • Edogawa Medicare Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • JCHO Tokyo Shinjuku Medical Center
  • Tokyo Medical University Hachioji Medical Center
  • National Hospital Organization Kasumigaura Medical Center
  • Mie Prefectural Medical Centre
  • CIMAB SA de CV
  • Panamerican Clinical Research S.A de C.V.
  • Clinstile S.A de C.V.
  • PanAmerican Clinical Research, Querétaro
  • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • CEPREP; Hospital Universitario
  • Hospital Senhora da Oliveira - Guimaraes, E.P.E
  • Centro Hospitalar de Leiria (CHL)
  • Unidade Local de Saude de Matosinhos SA
  • Prof. Dr. Matei Bals Institute of Infectious Diseases
  • County Hospital Caracal
  • Sibiu Emergency Clinical County Hospital
  • Dr. Victor Babes Clinical Hospital of Pneumophthisiology and Infectious Diseases
  • Dr JM Engelbrecht Trial site
  • TASK Eden
  • Langeberg Clinical Trials
  • Clinical Projects Research
  • Hôpital Universitaire de Genève (HUG)
  • Universitätsspital Zürich
  • Gazi Universitesi Tip Fakultesi
  • Hacettepe University Medical Faculty
  • Koc University Medical Faculty Hospital
  • Ege University Medical Faculty
  • Karadeniz Technical University Faculty of Medicine
  • Ankara University Medical Faculty - PPDS
  • Istanbul University Cerrahpasa Medical Faculty Hospital; Tesvikiye Caddesi No:20
  • Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council
  • Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council
  • Public Non-Profit Enterprise "City Outpatient Clinic #9" of Kharkiv City Council
  • CNPE City Clinical Hospital #6 of DCC
  • Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council
  • CNPE Ivano-Frankivsk Regional Centre of Phthisiology and Pulmonology of IFRC
  • Private Enterprise Private Manufacture Company "Acinus", diagnostic and treatment center
  • Medical Center LLC "Harmony of Beauty"
  • CNE Kyiv City Clinical Hospital#1 of Exec. Body
  • Medical Center of LLC Preventclinic
  • Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail
  • Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem
  • Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
  • Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RO7496998 (AT-527)

Placebo

Arm Description

Orally administered, 550 mg twice daily (BID) for 5 days

The dose and regimen of the placebo will match that of AT-527.

Outcomes

Primary Outcome Measures

Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 hours)
COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe). Alleviation of new symptoms is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 21.5 hours. For preexisting symptoms, the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 21.5 hours.

Secondary Outcome Measures

Time to Alleviation or Improvement of COVID-19 Symptoms (43 hours)
COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe). Alleviation of new symptoms is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 43 hours. For preexisting symptoms, the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 43 hours.
Time to Alleviation of COVID-19 Symptoms (21.5 hours)
Time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours. - Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary.
Time to Alleviation of COVID-19 Symptoms (43 hours)
Time from randomization to the point at which the following criterion is met and maintained for at least 43 hours. - Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary.
Time to One-Category Improvement of Baseline Presenting COVID-19 Symptoms
Time from randomization to the point at which symptoms have improved by at least one category from baseline on the COVID-19 Symptom Diary Likert scale, maintained for at least 21.5 hours.
Time to Alleviation of Individual Symptoms
Time from randomization to the point at which the following criterion is met and maintained (for each individual symptom) for at least 21.5 hours. - Score of 0 or 1 for Items 1-14 of the COVID-19 Symptom Diary
Proportion of Participants Requiring Hospitalization for COVID-19
Proportion of Participants with Greater than or Equal to 1 COVID-19 Related Medically Attended Visit
Medically attended visit is defined as hospitalization, emergency room (ER) visit, urgent care visit, physician's office visit, or telemedicine visit, with the primary reason for the visit being COVID-19.
Duration of Fever
Time to return to an afebrile state (temperature ≤ 37.5°C) maintained for at least 21.5 hours
Frequency of COVID-19 Related Complications
Examples of COVID-19 related complications include death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis and cardiac failure.
Proportion of Participants with any Post-Treatment Infection
Change from Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA
SARS-CoV-2 virus RNA will be measured by reverse-transcriptase quantitative polymerase chain reaction (RT-qPCR)
Time to Cessation of SARS-CoV-2 Viral Shedding
Defined as the length of time from randomization to first time when the virus RNA by RT-qPCR is below the limit of detection.
Proportion of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints
Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA
AUC in the amount of SARS-CoV-2 virus RNA from randomization to the last sample timepoint.
Percentage of Participants with Adverse Events (AEs)
Plasma Concentration of AT-511, AT-551, AT-229 and AT-273 at Specified Timepoints
AT-511 is the free base form of RO7496998 (AT-527). Major metabolites are AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010)

Full Information

First Posted
May 10, 2021
Last Updated
January 21, 2022
Sponsor
Hoffmann-La Roche
Collaborators
Atea Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04889040
Brief Title
Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19
Acronym
MORNINGSKY
Official Title
A Multicenter, Phase III Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Evaluate the Efficacy, Safety, Antiviral Activity of RO7496998 (AT-527) in Patients With Mild or Moderate COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Based on program revaluation and in agreement with the co-development partner the sponsor took the decision to terminate this study.
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
November 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Atea Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Coronavirus Disease 2019; COVID-19; antiviral drug; SARS-CoV-2; Mild to Moderate COVID-19; antiviral efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1386 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RO7496998 (AT-527)
Arm Type
Experimental
Arm Description
Orally administered, 550 mg twice daily (BID) for 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The dose and regimen of the placebo will match that of AT-527.
Intervention Type
Drug
Intervention Name(s)
RO7496998
Other Intervention Name(s)
AT-527
Intervention Description
275 mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching tablets
Primary Outcome Measure Information:
Title
Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 hours)
Description
COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe). Alleviation of new symptoms is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 21.5 hours. For preexisting symptoms, the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 21.5 hours.
Time Frame
Up to 29 days
Secondary Outcome Measure Information:
Title
Time to Alleviation or Improvement of COVID-19 Symptoms (43 hours)
Description
COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe). Alleviation of new symptoms is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 43 hours. For preexisting symptoms, the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 43 hours.
Time Frame
Up to 29 days
Title
Time to Alleviation of COVID-19 Symptoms (21.5 hours)
Description
Time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours. - Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary.
Time Frame
Up to 29 days
Title
Time to Alleviation of COVID-19 Symptoms (43 hours)
Description
Time from randomization to the point at which the following criterion is met and maintained for at least 43 hours. - Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary.
Time Frame
Up to 29 days
Title
Time to One-Category Improvement of Baseline Presenting COVID-19 Symptoms
Description
Time from randomization to the point at which symptoms have improved by at least one category from baseline on the COVID-19 Symptom Diary Likert scale, maintained for at least 21.5 hours.
Time Frame
Up to 29 days
Title
Time to Alleviation of Individual Symptoms
Description
Time from randomization to the point at which the following criterion is met and maintained (for each individual symptom) for at least 21.5 hours. - Score of 0 or 1 for Items 1-14 of the COVID-19 Symptom Diary
Time Frame
Up to 29 days
Title
Proportion of Participants Requiring Hospitalization for COVID-19
Time Frame
Up to 33 days
Title
Proportion of Participants with Greater than or Equal to 1 COVID-19 Related Medically Attended Visit
Description
Medically attended visit is defined as hospitalization, emergency room (ER) visit, urgent care visit, physician's office visit, or telemedicine visit, with the primary reason for the visit being COVID-19.
Time Frame
Up to 33 days
Title
Duration of Fever
Description
Time to return to an afebrile state (temperature ≤ 37.5°C) maintained for at least 21.5 hours
Time Frame
Up to 29 days
Title
Frequency of COVID-19 Related Complications
Description
Examples of COVID-19 related complications include death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis and cardiac failure.
Time Frame
Up to 33 days
Title
Proportion of Participants with any Post-Treatment Infection
Time Frame
Up to 33 days
Title
Change from Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA
Description
SARS-CoV-2 virus RNA will be measured by reverse-transcriptase quantitative polymerase chain reaction (RT-qPCR)
Time Frame
Up to 14 days
Title
Time to Cessation of SARS-CoV-2 Viral Shedding
Description
Defined as the length of time from randomization to first time when the virus RNA by RT-qPCR is below the limit of detection.
Time Frame
Up to 14 days
Title
Proportion of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints
Time Frame
Up to 14 days
Title
Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA
Description
AUC in the amount of SARS-CoV-2 virus RNA from randomization to the last sample timepoint.
Time Frame
Up to 14 days
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
Up to 33 days
Title
Plasma Concentration of AT-511, AT-551, AT-229 and AT-273 at Specified Timepoints
Description
AT-511 is the free base form of RO7496998 (AT-527). Major metabolites are AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010)
Time Frame
Up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) ≤72 hours prior to randomization At least three of the following symptoms of at least moderate (score ≥2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea. Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days before dosing on Day 1 Exclusion Criteria: Clinical signs indicative of COVID-19 illness requiring hospitalization Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19 In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization Treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization Treatment with a COVID-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against SARS-CoV-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2 or interleukin 6 (IL-6), intravenous immunoglobulin or other EUA-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit Concomitant use of P-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol Known allergy or hypersensitivity to components of study drug Abnormal laboratory test results at screening Requirement of any prohibited medications during the study Other known active viral or bacterial infection at the time of screening, such as influenza Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study COVID-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Medico Rio Cuarto
City
Cordoba
ZIP/Postal Code
5800
Country
Argentina
Facility Name
Instituto Ave Pulmo
City
Mar Del Plata
ZIP/Postal Code
B7602DCK
Country
Argentina
Facility Name
Clínica Independencia
City
Munro
ZIP/Postal Code
1605
Country
Argentina
Facility Name
Instituto Medico de la Fundacion Estudios Clinicos
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Clinica Mayo de U.M.C.B. S.R.L
City
San Miguel de Tucumán
ZIP/Postal Code
T4000IHE
Country
Argentina
Facility Name
Sanatorio Medico de Diagnostico Y Tratamiento
City
Santa Fe
ZIP/Postal Code
S3000FUJ
Country
Argentina
Facility Name
Maison Médicale La Brèche
City
Châtelineau
ZIP/Postal Code
6200
Country
Belgium
Facility Name
Private Practice Dr Jean Benoit Martinot
City
Erpent
ZIP/Postal Code
5101
Country
Belgium
Facility Name
Medif
City
Gozée
ZIP/Postal Code
6534
Country
Belgium
Facility Name
L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar
City
Brasilia
State/Province
DF
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Chronos Pesquisa Clinica
City
Taguatinga
State/Province
DF
ZIP/Postal Code
72145-450
Country
Brazil
Facility Name
Hospital das Clinicas - UFMG
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
31270-901
Country
Brazil
Facility Name
Hospital Agamenon Magalhães
City
Recife
State/Province
PE
ZIP/Postal Code
52051-380
Country
Brazil
Facility Name
Hospital Nossa Senhora das Graças
City
Curitiba
State/Province
PR
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Hospital Erasto Gaertner
City
Curitiba
State/Province
PR
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Hospital E Maternidade Celso Pierro PUCCAMP
City
Campinas
State/Province
SP
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
City
Sao Jose Do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
CPQuali Pesquisa Clínica Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Institute of Infectious Diseases Emilio Ribas
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-900
Country
Brazil
Facility Name
Conjunto Hospitalar do Mandaqui
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
02401-400
Country
Brazil
Facility Name
Healthy Medical Center SAS
City
Zipaquirá
Country
Colombia
Facility Name
Aalborg Universitetshospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Rigshospitalet Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Sjællands Universitetshospital, Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Hôpital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Praxis am Ebertplatz
City
Köln
ZIP/Postal Code
50668
Country
Germany
Facility Name
ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco
City
Lecco
State/Province
Lombardia
ZIP/Postal Code
23900
Country
Italy
Facility Name
Ospedale San Raffaele S.r.l.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Comprensorio Amedeo Di Savoia Birago Di Vische
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10149
Country
Italy
Facility Name
Funabashi Central Hospital
City
Funabashi-Shi
ZIP/Postal Code
273-0021
Country
Japan
Facility Name
Higashiosaka city Medical Center
City
Higashiosaka-Shi
ZIP/Postal Code
578-0947
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumisano
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
Sagamihara Kyodo Hospital
City
Kanagawa
ZIP/Postal Code
252-5188
Country
Japan
Facility Name
Misyuku hospital
City
Meguro-Ku
ZIP/Postal Code
153-0051
Country
Japan
Facility Name
Nagoya City East Medical Center
City
Nagoya-Shi Chikusa-Ku
ZIP/Postal Code
464-0071
Country
Japan
Facility Name
Fujita Health University Banbuntane Hotokukai Hospital
City
Nagoya-shi
ZIP/Postal Code
454-8509
Country
Japan
Facility Name
Tokyo Metropolitan Police Hospital
City
Nakano-Ku
ZIP/Postal Code
164-0001
Country
Japan
Facility Name
IUHW Narita Hospital
City
Narita
ZIP/Postal Code
286-8520
Country
Japan
Facility Name
Houjin Syadan Kouhoukai Takagi Hospital
City
Okawa-Shi
ZIP/Postal Code
831-0016
Country
Japan
Facility Name
Okayama City Hospital
City
Okayama
ZIP/Postal Code
700-8557
Country
Japan
Facility Name
Ome Municipal General Hospital
City
Ome-Shi
ZIP/Postal Code
198-0042
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Sakai-shi
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
City
Shinagawa
ZIP/Postal Code
140-8522
Country
Japan
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Edogawa Medicare Hospital
City
Tokyo
ZIP/Postal Code
133-0071
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Tokyo
ZIP/Postal Code
162-0052
Country
Japan
Facility Name
JCHO Tokyo Shinjuku Medical Center
City
Tokyo
ZIP/Postal Code
162-8543
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
National Hospital Organization Kasumigaura Medical Center
City
Tsuchiurat
ZIP/Postal Code
300-0812
Country
Japan
Facility Name
Mie Prefectural Medical Centre
City
Yokkaichi
ZIP/Postal Code
510-8561
Country
Japan
Facility Name
CIMAB SA de CV
City
Torreón
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Panamerican Clinical Research S.A de C.V.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Clinstile S.A de C.V.
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06700
Country
Mexico
Facility Name
PanAmerican Clinical Research, Querétaro
City
Queréaro
State/Province
Queretaro
ZIP/Postal Code
76230
Country
Mexico
Facility Name
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
City
Guadalajara
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico
Country
Mexico
Facility Name
CEPREP; Hospital Universitario
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Senhora da Oliveira - Guimaraes, E.P.E
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar de Leiria (CHL)
City
Leiria
ZIP/Postal Code
2410-197
Country
Portugal
Facility Name
Unidade Local de Saude de Matosinhos SA
City
Matosinhos
ZIP/Postal Code
4454-509
Country
Portugal
Facility Name
Prof. Dr. Matei Bals Institute of Infectious Diseases
City
Bucuresti
ZIP/Postal Code
021105
Country
Romania
Facility Name
County Hospital Caracal
City
Caracal
ZIP/Postal Code
235200
Country
Romania
Facility Name
Sibiu Emergency Clinical County Hospital
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Dr. Victor Babes Clinical Hospital of Pneumophthisiology and Infectious Diseases
City
Timişoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
Dr JM Engelbrecht Trial site
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
TASK Eden
City
George
ZIP/Postal Code
6530
Country
South Africa
Facility Name
Langeberg Clinical Trials
City
Kraaifontein
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Clinical Projects Research
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Hôpital Universitaire de Genève (HUG)
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Gazi Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Koc University Medical Faculty Hospital
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Karadeniz Technical University Faculty of Medicine
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Ankara University Medical Faculty - PPDS
City
Çankaya
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty Hospital; Tesvikiye Caddesi No:20
City
Şi̇şli̇
ZIP/Postal Code
34365
Country
Turkey
Facility Name
Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council
City
Ivano-Frankivsk
State/Province
Katerynoslav Governorate
ZIP/Postal Code
76025
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
Public Non-Profit Enterprise "City Outpatient Clinic #9" of Kharkiv City Council
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61172
Country
Ukraine
Facility Name
CNPE City Clinical Hospital #6 of DCC
City
Dnipro
State/Province
Kholm Governorate
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council
City
Dnipro
State/Province
KIEV Governorate
ZIP/Postal Code
41102
Country
Ukraine
Facility Name
CNPE Ivano-Frankivsk Regional Centre of Phthisiology and Pulmonology of IFRC
City
Ivano Frankivsk
State/Province
KIEV Governorate
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Private Enterprise Private Manufacture Company "Acinus", diagnostic and treatment center
City
Kirovograd
State/Province
KIEV Governorate
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
Medical Center LLC "Harmony of Beauty"
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
01135
Country
Ukraine
Facility Name
CNE Kyiv City Clinical Hospital#1 of Exec. Body
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Medical Center of LLC Preventclinic
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
03035
Country
Ukraine
Facility Name
Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
City
Vinnytsya
State/Province
Podolia Governorate
Country
Ukraine
Facility Name
Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council
City
Zaporizhzhia
State/Province
Tavria Okruha
ZIP/Postal Code
69118
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

Learn more about this trial

Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19

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