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Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness (BIRCH)

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Obeldesivir
Obeldesivir Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

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

Key Inclusion Criteria: Willing and able to provide written informed consent. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by PCR or an approved alternative assay (eg. Rapid Antigen Test) ≤ 5 days before randomization. Serologic tests will not be accepted. Initial onset of COVID-19 signs/symptoms ≤ 5 days before randomization. Not currently hospitalized or requiring hospitalization. Presence of ≥ 1 risk factor (if unvaccinated) or ≥ 2 risk factors (if vaccinated at any point) for progression to severe disease. Key Exclusion Criteria: Anticipated use of COVID-19 therapies during the current COVID-19 illness. Received any direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization. Anticipated need for hospitalization < 48 hours after randomization. New oxygen requirement < 24 hours before randomization. Decompensated cirrhosis (Child-Pugh class B or C) or acute liver injury/failure. Undergoing dialysis, or history of moderate to severe renal impairment. Pregnant or breastfeeding (nursing). Unwilling to use protocol-mandated birth control. Received an approved, authorized or investigational COVID-19 vaccine (including booster dose) <120 days before randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Faculdade de Medicina da Universidade Federal de Minas Gerais
  • L2iP Instituto de Pesquisas Clínicas
  • Hospital da PUC Campinas - Centro de Pesquisa Sao Lucas
  • Hospital do Rocio/ Maternidade e Cirurgia Nossa Senhora do Rocio
  • Centro de Pesquisa NEIMPI - Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
  • Centro de Pesquisa Clinica da Universidade Municipal de São Caetano do Sul (USCS)
  • Faculdade de Medicina da Universidade Estadual Paulista-UNESP/HC da Faculdade de Medicina de Botucatu-HCFMB
  • Multiprofile Hospital for Active Treatment Puls AD, Department of Internal Diseases
  • Medical Center Asklepii OOD
  • Specialìzed Hosp¡tal for Active Trealment of Pneumophthisiatric Diseases Haskovo EOOD, Department of pneumology and phthisiatry
  • Medical Center Zdrave-1 OOD
  • Diagnostic Consultative Center 1 - Lon EOOD
  • Medical Center Hera EOOD, Montana
  • Multiprofile Hospital for Active Treatment Dr. Stamen Iliev AD, Department of Pneumology Phthisiatrics
  • Medical Center Medconsult Pleven OOD
  • University Multiprofile Hospital for Active Treatment Sveta Marina - Pleven OOD, Clinic of Anesthesiology and lntensive Care
  • Diagnostic Consultative Center Sveti Georgi EOOD
  • MHAT Sveta Karidad EAD, First Department of Anesthesiology and Intensive Care
  • Multiprofile Hospital for Active Treatment Sveti Panteleymon EOOD, First Department of Internal Diseases
  • Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Razgrad AD, Department of pneumology and phthisiatry
  • Medical Center Prolet EOOD
  • Multiprofile Hospital for Active Treatment - Samokov EOOD, Department of Internal Diseases
  • Medical Center Unimed EOOD
  • Diagnostic and Consulting Center Aleksandrovska EOOD
  • Medical Center Hera EOOD
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine ,,N. l. Pirogov" EAD,Clinic of lnternal Diseases
  • Diagnostic Consultative Center XX - Sofia EOOD
  • University Multiprofile Hospital for Active Treatment Sofiamed OOD, block 2, Department of lnfectious Diseases, COVID cabinet
  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD, Infectious Diseases Clinic
  • Medical Center Leo Clinic EOOD
  • Medical Center Sanador M EOOD
  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa EOOD, Department of Pneumology
  • Hamilton Medical Research Group
  • Dr. Anil K. Gupta Medicine Professional Corporation
  • Vancouver ID Research and Care Centre Society
  • FamilyMED s.r.o.
  • Neocnice Nove Mesto Morave p.o. Infekcni oddeleni
  • MEDISON, s.r.o.
  • Hopital Gabriel Montpied
  • Hopital St Joseph
  • CHU de Montpellier-Hopital La Colombiere
  • CHU Caremeau
  • Hopital Pitie Salpetriere
  • Hopital Saint Louis
  • CH de Tourcoing
  • Debreceni Egyetem Klinikai Kozpont
  • Unita Operativa Di Malattie Infettive Ospedale San Raffaele S.r.l.
  • Dipartimento di Malattie Infettive Ospedale Luigi Sacco ASST Fatebenefratelli Sacco
  • SC Malattie Infettive ASST GOM Niguarda
  • Azienda Universitaria Federico II - UOC Malattie Infettive
  • Divisione di Malattie Infettive Azienda Ospedaliero Universitaria Pisana
  • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS - U.O.C. Malattie Infettive ad Alta Intensita di Cura
  • IUHW Narita Hospital
  • Okayama University Hospital
  • Suita Municipal Hospital
  • ChungNam National University Hospital
  • Chonnam National University Hospital
  • Chonnam National University Bitgoeul Hospital
  • Seoul Medical Center
  • Hallym University Kangdong Sacred Heart Hospital
  • Korea University Guro Hospital
  • Centro Regional de Infectologia del Norte de Mexico
  • Panamerican Clinical Research Mexico S.A. de C.V.
  • Neurociencias Estudios Clinicos S.C.
  • PanAmerican Clinical Research Mexico S.A de C.V.
  • EME RED Hospitalaria
  • Clinstile, S.A. De C.V.
  • Sociedad Administradora de Servicios de Salud, S.C.
  • Kohler & Milstein Research S.A de C.V.
  • Oaxaca Site Management Organization S.C.
  • FAICIC S. de R.L. de C.V.
  • ClinMedica Research
  • Centrum Medyczne Pulawska Sp. z o.o
  • Provita Poliklinika
  • Centrum Badan Klinicznych JCI
  • Ginemedica OVO 21
  • ETG Lodz
  • Hospital Senhora da Oliveira - Guimareas EPE
  • Hospital CUF Descobertas
  • Centro Hospitalar Universitario de Santo Antonio E.P.E
  • Centro Hospitalar de Entre Douro e Vouga - Hospital de Sao Sebaststiao
  • Hospital da Luz - Arrabida
  • "Prof. Dr. Matei Bals" National Institute for Infectious Diseases
  • County Hospital Caracal
  • Sibiu Emergency Clinical County Hospital
  • National University Hospital
  • National Centre for Infectious Diseases, Tan Tock Seng Hospital
  • Madibeng Centre for Research
  • Clinresco Centres (Pty) Ltd
  • Synapta Clinical Research Centre
  • Perinatal HIV Research Unit (PHRU)
  • Setshaba Research Centre
  • Jongaie Research
  • Global Clinical Trials
  • Limpopo Clinical Research Initiative
  • FCRN Clinical Trial Centre (Pty) Ltd
  • Hospital Universitario A Coruña
  • Hospital Universitario Virgen de Las Nieves.Recruiting
  • Hospital General Universitario Dr. Balmis
  • Hospital Universitari Germans Trias i Pujol
  • Hospital del Mar
  • CAP La Mina
  • Hospital HM Nou Delfos
  • Hospital Clinic de Barcelona
  • Hospital Universitario de Bellvitge
  • Hospital General Universitario De Elche
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitario Infanta Leonor
  • Hospital Clinico San Carlos
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta de Hierro - MajadahondaRecruiting
  • Hospital Costa Del Sol
  • Hospital General Universitario Reina Sofia
  • Hospital Universitario Son Espases
  • Hospital Universitaro y Politecnico La Fe
  • Hospital Clinico Universitario de Valladolid
  • Hopitaux Universitaires de Geneve (HUG)
  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • Far Eastern Memorial Hospital
  • China Medical University Hospital
  • Chi Mei Medical Center
  • National Taiwan University Hospital
  • Tao-Yuan General Hospital
  • Chang Gung Memorial Hospital (CGMH)
  • Kaohsiung Veterans General Hospital
  • Izmir Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
  • Cukurova University Medical Faculty Balcali Hospital
  • Acibadem University School of Medicine Atakent Hospital
  • Karadeniz Technical University Faculty of Medicine
  • Ormeau Clinical Trials Limited
  • Lakeside Healthcare
  • CPS Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Obeldesivir

Placebo

Arm Description

Participants will receive obeldesivir 350 mg twice daily for 5 days.

Participants will receive placebo twice daily for 5 days.

Outcomes

Primary Outcome Measures

Proportion of Coronavirus Disease 2019 (COVID-19)- Related Hospitalizations or All-cause Death by Day 29

Secondary Outcome Measures

Percentage Of Participants With Treatment-Emergent Adverse Events
Percentage of Participants Experiencing Laboratory Abnormalities
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
Proportion of Participants With All-cause Hospitalization by Day 29
Proportion of Participants With COVID-19-related Medically Attended Visits (MAVs) or All-cause Death by Day 29
Proportion of Participants With COVID-19-related MAVs by Day 29
Proportion of Participants With All-cause Death by Day 29
Time to COVID-19 Symptom Alleviation by Day 15
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Pharmacokinetic (PK) Parameter: AUCtau of GS-441524
AUCtau is defined as the area under the concentration versus time curve over the dosing interval
PK Parameter: Ctau of GS-441524
Ctau is defined as the observed drug concentration at the end of the dosing interval
PK Parameter: Cmax of GS-441524
Cmax is defined as the maximum observed plasma concentration of drug

Full Information

First Posted
October 31, 2022
Last Updated
October 18, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05603143
Brief Title
Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness
Acronym
BIRCH
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical study is to test how well the study drug, obeldesivir (formerly GS-5245), works and how safe it is in treating coronavirus disease 2019 (COVID-19) in participants that have a higher risk of getting a serious illness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obeldesivir
Arm Type
Experimental
Arm Description
Participants will receive obeldesivir 350 mg twice daily for 5 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo twice daily for 5 days.
Intervention Type
Drug
Intervention Name(s)
Obeldesivir
Other Intervention Name(s)
GS-5245
Intervention Description
Tablets administered orally without regard to food.
Intervention Type
Drug
Intervention Name(s)
Obeldesivir Placebo
Intervention Description
Placebo tablets administered orally without regard to food.
Primary Outcome Measure Information:
Title
Proportion of Coronavirus Disease 2019 (COVID-19)- Related Hospitalizations or All-cause Death by Day 29
Time Frame
First dose date up to Day 29
Secondary Outcome Measure Information:
Title
Percentage Of Participants With Treatment-Emergent Adverse Events
Time Frame
First dose date up to Day 5 plus 30 days
Title
Percentage of Participants Experiencing Laboratory Abnormalities
Time Frame
First dose date up to Day 5 plus 30 days
Title
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
Time Frame
First dose date up to Day 5 plus 30 days
Title
Proportion of Participants With All-cause Hospitalization by Day 29
Time Frame
First dose date up to Day 29
Title
Proportion of Participants With COVID-19-related Medically Attended Visits (MAVs) or All-cause Death by Day 29
Time Frame
First dose date up to Day 29
Title
Proportion of Participants With COVID-19-related MAVs by Day 29
Time Frame
First dose date up to Day 29
Title
Proportion of Participants With All-cause Death by Day 29
Time Frame
First dose date up to Day 29
Title
Time to COVID-19 Symptom Alleviation by Day 15
Time Frame
First dose date up to Day 15
Title
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5
Time Frame
Baseline, Day 5
Title
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Time Frame
Day 1 and Day 5
Title
Pharmacokinetic (PK) Parameter: AUCtau of GS-441524
Description
AUCtau is defined as the area under the concentration versus time curve over the dosing interval
Time Frame
Day 1 and Day 5
Title
PK Parameter: Ctau of GS-441524
Description
Ctau is defined as the observed drug concentration at the end of the dosing interval
Time Frame
Day 1 and Day 5
Title
PK Parameter: Cmax of GS-441524
Description
Cmax is defined as the maximum observed plasma concentration of drug
Time Frame
Day 1 and Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Willing and able to provide written informed consent. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by PCR or an approved alternative assay (eg. Rapid Antigen Test) ≤ 5 days before randomization. Serologic tests will not be accepted. Initial onset of COVID-19 signs/symptoms ≤ 5 days before randomization. Not currently hospitalized or requiring hospitalization. Presence of ≥ 1 risk factor (if unvaccinated) or ≥ 2 risk factors (if vaccinated at any point) for progression to severe disease. Key Exclusion Criteria: Anticipated use of COVID-19 therapies during the current COVID-19 illness. Received any direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization. Anticipated need for hospitalization < 48 hours after randomization. New oxygen requirement < 24 hours before randomization. Decompensated cirrhosis (Child-Pugh class B or C) or acute liver injury/failure. Undergoing dialysis, or history of moderate to severe renal impairment. Pregnant or breastfeeding (nursing). Unwilling to use protocol-mandated birth control. Received an approved, authorized or investigational COVID-19 vaccine (including booster dose) <120 days before randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilead Clinical Study Information Center
Phone
1-833-445-3230 (GILEAD-0)
Email
GileadClinicalTrials@gilead.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Faculdade de Medicina da Universidade Federal de Minas Gerais
City
Belo Horizonte - MG
ZIP/Postal Code
30130-100
Country
Brazil
Individual Site Status
Completed
Facility Name
L2iP Instituto de Pesquisas Clínicas
City
Brasília - DF
ZIP/Postal Code
70200-730
Country
Brazil
Individual Site Status
Completed
Facility Name
Hospital da PUC Campinas - Centro de Pesquisa Sao Lucas
City
Campinas
ZIP/Postal Code
13060-904
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Hospital do Rocio/ Maternidade e Cirurgia Nossa Senhora do Rocio
City
Campo Largo
ZIP/Postal Code
83606
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Centro de Pesquisa NEIMPI - Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
City
Ribeirao Preto
ZIP/Postal Code
14051
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Centro de Pesquisa Clinica da Universidade Municipal de São Caetano do Sul (USCS)
City
São Caetano Do Sul - SP
ZIP/Postal Code
09530-905
Country
Brazil
Individual Site Status
Completed
Facility Name
Faculdade de Medicina da Universidade Estadual Paulista-UNESP/HC da Faculdade de Medicina de Botucatu-HCFMB
City
São Paulo
ZIP/Postal Code
03272-060
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Multiprofile Hospital for Active Treatment Puls AD, Department of Internal Diseases
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Center Asklepii OOD
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Specialìzed Hosp¡tal for Active Trealment of Pneumophthisiatric Diseases Haskovo EOOD, Department of pneumology and phthisiatry
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Center Zdrave-1 OOD
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Diagnostic Consultative Center 1 - Lon EOOD
City
Lom
ZIP/Postal Code
3600
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Center Hera EOOD, Montana
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Multiprofile Hospital for Active Treatment Dr. Stamen Iliev AD, Department of Pneumology Phthisiatrics
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Center Medconsult Pleven OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Completed
Facility Name
University Multiprofile Hospital for Active Treatment Sveta Marina - Pleven OOD, Clinic of Anesthesiology and lntensive Care
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Diagnostic Consultative Center Sveti Georgi EOOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Completed
Facility Name
MHAT Sveta Karidad EAD, First Department of Anesthesiology and Intensive Care
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Multiprofile Hospital for Active Treatment Sveti Panteleymon EOOD, First Department of Internal Diseases
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Razgrad AD, Department of pneumology and phthisiatry
City
Razgrad
ZIP/Postal Code
7200
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Medical Center Prolet EOOD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Multiprofile Hospital for Active Treatment - Samokov EOOD, Department of Internal Diseases
City
Samokov
ZIP/Postal Code
2000
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Center Unimed EOOD
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Diagnostic and Consulting Center Aleksandrovska EOOD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Center Hera EOOD
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Individual Site Status
Completed
Facility Name
University Multiprofile Hospital for Active Treatment and Emergency Medicine ,,N. l. Pirogov" EAD,Clinic of lnternal Diseases
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Diagnostic Consultative Center XX - Sofia EOOD
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Individual Site Status
Completed
Facility Name
University Multiprofile Hospital for Active Treatment Sofiamed OOD, block 2, Department of lnfectious Diseases, COVID cabinet
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD, Infectious Diseases Clinic
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Medical Center Leo Clinic EOOD
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Medical Center Sanador M EOOD
City
Vidin
ZIP/Postal Code
3700
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa EOOD, Department of Pneumology
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Hamilton Medical Research Group
City
Hamilton
ZIP/Postal Code
L8M 1K7
Country
Canada
Individual Site Status
Completed
Facility Name
Dr. Anil K. Gupta Medicine Professional Corporation
City
Toronto
ZIP/Postal Code
M9V 4B4
Country
Canada
Individual Site Status
Completed
Facility Name
Vancouver ID Research and Care Centre Society
City
Vancouver
ZIP/Postal Code
V6Z 2C9
Country
Canada
Individual Site Status
Completed
Facility Name
FamilyMED s.r.o.
City
Brno
ZIP/Postal Code
612 00
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
Neocnice Nove Mesto Morave p.o. Infekcni oddeleni
City
Nove Mesto na Morave
ZIP/Postal Code
59231
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
MEDISON, s.r.o.
City
Přeštice
ZIP/Postal Code
334 01
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
Hopital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopital St Joseph
City
Marseille
ZIP/Postal Code
13285
Country
France
Individual Site Status
Withdrawn
Facility Name
CHU de Montpellier-Hopital La Colombiere
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Completed
Facility Name
CHU Caremeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopital Pitie Salpetriere
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Individual Site Status
Suspended
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Withdrawn
Facility Name
CH de Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Individual Site Status
Withdrawn
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Individual Site Status
Completed
Facility Name
Unita Operativa Di Malattie Infettive Ospedale San Raffaele S.r.l.
City
Milano
ZIP/Postal Code
20127
Country
Italy
Individual Site Status
Completed
Facility Name
Dipartimento di Malattie Infettive Ospedale Luigi Sacco ASST Fatebenefratelli Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Withdrawn
Facility Name
SC Malattie Infettive ASST GOM Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Azienda Universitaria Federico II - UOC Malattie Infettive
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Divisione di Malattie Infettive Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS - U.O.C. Malattie Infettive ad Alta Intensita di Cura
City
Roma
ZIP/Postal Code
00149
Country
Italy
Individual Site Status
Withdrawn
Facility Name
IUHW Narita Hospital
City
Chibaken
ZIP/Postal Code
286-0124
Country
Japan
Individual Site Status
Completed
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Completed
Facility Name
Suita Municipal Hospital
City
Suita
ZIP/Postal Code
564-8567
Country
Japan
Individual Site Status
Completed
Facility Name
ChungNam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Chonnam National University Bitgoeul Hospital
City
Gwangju
ZIP/Postal Code
61748
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Seoul Medical Center
City
Seoul
ZIP/Postal Code
02053
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Hallym University Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
05355
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Centro Regional de Infectologia del Norte de Mexico
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Panamerican Clinical Research Mexico S.A. de C.V.
City
Col. El Salitre Juriquilla
ZIP/Postal Code
13030
Country
Mexico
Individual Site Status
Completed
Facility Name
Neurociencias Estudios Clinicos S.C.
City
Culiacan Sinaloa
ZIP/Postal Code
80020
Country
Mexico
Individual Site Status
Completed
Facility Name
PanAmerican Clinical Research Mexico S.A de C.V.
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Completed
Facility Name
EME RED Hospitalaria
City
Merida
ZIP/Postal Code
97000
Country
Mexico
Individual Site Status
Completed
Facility Name
Clinstile, S.A. De C.V.
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Completed
Facility Name
Sociedad Administradora de Servicios de Salud, S.C.
City
Morelia
ZIP/Postal Code
58260
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Kohler & Milstein Research S.A de C.V.
City
Mérida
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Completed
Facility Name
Oaxaca Site Management Organization S.C.
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Individual Site Status
Completed
Facility Name
FAICIC S. de R.L. de C.V.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Completed
Facility Name
ClinMedica Research
City
Skierniewice
State/Province
Lodzkie
ZIP/Postal Code
96-100
Country
Poland
Individual Site Status
Suspended
Facility Name
Centrum Medyczne Pulawska Sp. z o.o
City
Piaseczno
ZIP/Postal Code
05500
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Provita Poliklinika
City
Warszawa
ZIP/Postal Code
02-091
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Centrum Badan Klinicznych JCI
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Ginemedica OVO 21
City
Wroclaw
ZIP/Postal Code
50414
Country
Poland
Individual Site Status
Completed
Facility Name
ETG Lodz
City
Zgierz
ZIP/Postal Code
95-100
Country
Poland
Individual Site Status
Completed
Facility Name
Hospital Senhora da Oliveira - Guimareas EPE
City
Braga
ZIP/Postal Code
4835-044
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
Hospital CUF Descobertas
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Completed
Facility Name
Centro Hospitalar Universitario de Santo Antonio E.P.E
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
Centro Hospitalar de Entre Douro e Vouga - Hospital de Sao Sebaststiao
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Individual Site Status
Completed
Facility Name
Hospital da Luz - Arrabida
City
Vila Nova de Gaia
ZIP/Postal Code
4099-346
Country
Portugal
Individual Site Status
Completed
Facility Name
"Prof. Dr. Matei Bals" National Institute for Infectious Diseases
City
Bucharest
ZIP/Postal Code
021105
Country
Romania
Individual Site Status
Completed
Facility Name
County Hospital Caracal
City
Caracal
ZIP/Postal Code
235200
Country
Romania
Individual Site Status
Completed
Facility Name
Sibiu Emergency Clinical County Hospital
City
Sibiu
ZIP/Postal Code
550253
Country
Romania
Individual Site Status
Completed
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Withdrawn
Facility Name
National Centre for Infectious Diseases, Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Completed
Facility Name
Madibeng Centre for Research
City
Brits
ZIP/Postal Code
0250
Country
South Africa
Individual Site Status
Completed
Facility Name
Clinresco Centres (Pty) Ltd
City
City Of Johannesburg
ZIP/Postal Code
1619
Country
South Africa
Individual Site Status
Completed
Facility Name
Synapta Clinical Research Centre
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Individual Site Status
Completed
Facility Name
Perinatal HIV Research Unit (PHRU)
City
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Individual Site Status
Completed
Facility Name
Setshaba Research Centre
City
Limpopo
ZIP/Postal Code
0470
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Jongaie Research
City
Pretoria West
ZIP/Postal Code
0183
Country
South Africa
Individual Site Status
Completed
Facility Name
Global Clinical Trials
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Individual Site Status
Completed
Facility Name
Limpopo Clinical Research Initiative
City
Thabazimbi
ZIP/Postal Code
0380
Country
South Africa
Individual Site Status
Completed
Facility Name
FCRN Clinical Trial Centre (Pty) Ltd
City
Vereeniging
ZIP/Postal Code
1938
Country
South Africa
Individual Site Status
Completed
Facility Name
Hospital Universitario A Coruña
City
a Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario Virgen de Las Nieves.
City
a Gudiña
ZIP/Postal Code
32540
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Dr. Balmis
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Withdrawn
Facility Name
CAP La Mina
City
Barcelona
ZIP/Postal Code
8007
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital HM Nou Delfos
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital General Universitario De Elche
City
Elche
ZIP/Postal Code
03202
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario Virgen del Rocio
City
las Cabezas de San Juan
ZIP/Postal Code
41730
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Costa Del Sol
City
Marbella
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital General Universitario Reina Sofia
City
Murcia
ZIP/Postal Code
30003
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Son Espases
City
Palma de Mallorca
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitaro y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46016
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hopitaux Universitaires de Geneve (HUG)
City
Geneve 14
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Withdrawn
Facility Name
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Completed
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
22060
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Completed
Facility Name
Chi Mei Medical Center
City
Tainan City
ZIP/Postal Code
710
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Completed
Facility Name
Tao-Yuan General Hospital
City
Taoyuan City
ZIP/Postal Code
320
Country
Taiwan
Individual Site Status
Completed
Facility Name
Chang Gung Memorial Hospital (CGMH)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Kaohsiung Veterans General Hospital
City
Zuo Ying Qu
ZIP/Postal Code
813
Country
Taiwan
Individual Site Status
Completed
Facility Name
Izmir Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
City
Konak
ZIP/Postal Code
35170
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Cukurova University Medical Faculty Balcali Hospital
City
Nilüfer
ZIP/Postal Code
16265
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Acibadem University School of Medicine Atakent Hospital
City
Trabzon
ZIP/Postal Code
61030
Country
Turkey
Individual Site Status
Completed
Facility Name
Karadeniz Technical University Faculty of Medicine
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Ormeau Clinical Trials Limited
City
Belfast
ZIP/Postal Code
BT7 2EB
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Lakeside Healthcare
City
Corby
ZIP/Postal Code
NN17 2UR
Country
United Kingdom
Individual Site Status
Completed
Facility Name
CPS Research
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.gileadclinicaltrials.com/study/?id=GS-US-611-6273
Description
Gilead Clinical Trials Website

Learn more about this trial

Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness

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