LAST UPDATED
December 20, 2024
Clinicaltrials.gov ID
EudraCT ID
OVERVIEW
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 (BIRCH)
PROTOCOL SUMMARY
The goal of this clinical study is to test how well the study drug, obeldesivir (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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
COVID-19
Gender
N/A
Date
November 2022 - November 2023
Study Type
Interventional
Study Phase
Phase 3
Product
Obeldesivir, Obeldesivir Placebo
Eligibility information
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.
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.
Locations
Locations (81)
Faculdade de Medicina da Universidade Federal de Minas Gerais
Belo Horizonte - MG, Brazil, 30130-100
L2iP Instituto de Pesquisas Clínicas
Brasília - DF, Brazil, 70200-730
Centro de Pesquisa Clinica da Universidade Municipal de São Caetano do Sul (USCS)
São Caetano Do Sul - SP, Brazil, 09530-905
Multiprofile Hospital for Active Treatment Puls AD, Department of Internal Diseases
Blagoevgrad, Bulgaria, 2700
Specialìzed Hosp¡tal for Active Trealment of Pneumophthisiatric Diseases Haskovo EOOD, Department of pneumology and phthisiatry
Haskovo, Bulgaria, 6300
Multiprofile Hospital for Active Treatment Dr. Stamen Iliev AD, Department of Pneumology Phthisiatrics
Montana, Bulgaria, 3400
Diagnostic Consultative Center Sveti Georgi EOOD
Plovdiv, Bulgaria, 4000
MHAT Sveta Karidad EAD, First Department of Anesthesiology and Intensive Care
Plovdiv, Bulgaria, 4004
Multiprofile Hospital for Active Treatment Sveti Panteleymon EOOD, First Department of Internal Diseases
Plovdiv, Bulgaria, 4004
Multiprofile Hospital for Active Treatment - Samokov EOOD, Department of Internal Diseases
Samokov, Bulgaria, 2000
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, Bulgaria, 1431
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa EOOD, Department of Pneumology
Vratsa, Bulgaria, 3000
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Canada, M9V 4B4
Vancouver ID Research and Care Centre Society
Vancouver, Canada, V6Z 2C9
Unita Operativa Di Malattie Infettive Ospedale San Raffaele S.r.l.
Milan, Italy, 20127
Panamerican Clinical Research Mexico S.A. de C.V.
Col. El Salitre Juriquilla, Mexico, 13030
PanAmerican Clinical Research Mexico S.A de C.V.
Guadalajara, Mexico, 44670
Centro Hospitalar de Entre Douro e Vouga - Hospital de Sao Sebaststiao
Santa Maria da Feira, Portugal, 4520-211
"Prof. Dr. Matei Bals" National Institute for Infectious Diseases
Bucharest, Romania, 021105
National Centre for Infectious Diseases, Tan Tock Seng Hospital
Singapore, Singapore, 308433
Chonnam National University Bitgoeul Hospital
Gwangju, South Korea, 61748
Hospital Universitario Virgen del Rocio
Las Cabezas de San Juan, Spain, 41730
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Spain, 28222
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, Taiwan, 970
Acibadem University School of Medicine Atakent Hospital
Trabzon, Turkey (Türkiye), 61030
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