Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness
NCT ID: NCT05603143
Last Updated: 2024-12-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
468 participants
INTERVENTIONAL
2022-11-05
2023-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Obeldesivir
Participants will receive obeldesivir 350 mg orally twice daily for 5 days.
Obeldesivir
Tablets administered orally without regard to food.
Placebo
Participants will receive placebo-to-match obeldesivir orally twice daily for 5 days.
Obeldesivir Placebo
Placebo tablets administered orally without regard to food.
Interventions
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Obeldesivir
Tablets administered orally without regard to food.
Obeldesivir Placebo
Placebo tablets administered orally without regard to food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Faculdade de Medicina da Universidade Federal de Minas Gerais
Belo Horizonte - MG, , Brazil
L2iP Instituto de Pesquisas Clínicas
Brasília - DF, , Brazil
Centro de Pesquisa Clinica da Universidade Municipal de São Caetano do Sul (USCS)
São Caetano Do Sul - SP, , Brazil
Multiprofile Hospital for Active Treatment Puls AD, Department of Internal Diseases
Blagoevgrad, , Bulgaria
Medical Center Asklepii OOD
Dupnitsa, , Bulgaria
Specialìzed Hosp¡tal for Active Trealment of Pneumophthisiatric Diseases Haskovo EOOD, Department of pneumology and phthisiatry
Haskovo, , Bulgaria
Medical Center Zdrave-1 OOD
Kozloduy, , Bulgaria
Diagnostic Consultative Center 1 - Lon EOOD
Lom, , Bulgaria
Medical Center Hera EOOD, Montana
Montana, , Bulgaria
Multiprofile Hospital for Active Treatment Dr. Stamen Iliev AD, Department of Pneumology Phthisiatrics
Montana, , Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, , Bulgaria
Diagnostic Consultative Center Sveti Georgi EOOD
Plovdiv, , Bulgaria
MHAT Sveta Karidad EAD, First Department of Anesthesiology and Intensive Care
Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment Sveti Panteleymon EOOD, First Department of Internal Diseases
Plovdiv, , Bulgaria
Medical Center Prolet EOOD
Rousse, , Bulgaria
Multiprofile Hospital for Active Treatment - Samokov EOOD, Department of Internal Diseases
Samokov, , Bulgaria
Medical Center Unimed EOOD
Sevlievo, , Bulgaria
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, , Bulgaria
Medical Center Hera EOOD
Sofia, , Bulgaria
Diagnostic Consultative Center XX - Sofia EOOD
Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa EOOD, Department of Pneumology
Vratsa, , Bulgaria
Hamilton Medical Research Group
Hamilton, , Canada
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, , Canada
Vancouver ID Research and Care Centre Society
Vancouver, , Canada
CHU de Montpellier-Hopital La Colombiere
Montpellier, , France
Hopital Pitie Salpetriere
Paris, , France
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Unita Operativa Di Malattie Infettive Ospedale San Raffaele S.r.l.
Milan, , Italy
IUHW Narita Hospital
Chibaken, , Japan
Okayama University Hospital
Okayama, , Japan
Suita Municipal Hospital
Suita, , Japan
Panamerican Clinical Research Mexico S.A. de C.V.
Col. El Salitre Juriquilla, , Mexico
Neurociencias Estudios Clinicos S.C.
Culiacan Sinaloa, , Mexico
PanAmerican Clinical Research Mexico S.A de C.V.
Guadalajara, , Mexico
Clinstile, S.A. De C.V.
Mexico City, , Mexico
EME RED Hospitalaria
Mérida, , Mexico
Kohler & Milstein Research S.A de C.V.
Mérida, , Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, , Mexico
FAICIC S. de R.L. de C.V.
Veracruz, , Mexico
Ginemedica OVO 21
Wroclaw, , Poland
ETG Lodz
Zgierz, , Poland
ClinMedica Research
Skierniewice, Łódź Voivodeship, Poland
Hospital CUF Descobertas
Lisbon, , Portugal
Centro Hospitalar de Entre Douro e Vouga - Hospital de Sao Sebaststiao
Santa Maria da Feira, , Portugal
Hospital da Luz - Arrabida
Vila Nova de Gaia, , Portugal
"Prof. Dr. Matei Bals" National Institute for Infectious Diseases
Bucharest, , Romania
County Hospital Caracal
Caracal, , Romania
Sibiu Emergency Clinical County Hospital
Sibiu, , Romania
National Centre for Infectious Diseases, Tan Tock Seng Hospital
Singapore, , Singapore
Madibeng Centre for Research
Brits, , South Africa
Clinresco Centres (Pty) Ltd
City of Johannesburg, , South Africa
Synapta Clinical Research Centre
Durban, , South Africa
Perinatal HIV Research Unit (PHRU)
Johannesburg, , South Africa
Global Clinical Trials
Pretoria, , South Africa
Jongaie Research
Pretoria West, , South Africa
Limpopo Clinical Research Initiative
Thabazimbi, , South Africa
FCRN Clinical Trial Centre (Pty) Ltd
Vereeniging, , South Africa
ChungNam National University Hospital
Daejeon, , South Korea
Chonnam National University Bitgoeul Hospital
Gwangju, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital Universitario Virgen de Las Nieves.
A Gudiña, , Spain
Hospital General Universitario Dr. Balmis
Alicante, , Spain
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
CAP La Mina
Barcelona, , Spain
Hospital HM Nou Delfos
Barcelona, , Spain
Hospital Universitario Virgen del Rocio
Las Cabezas de San Juan, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, , Spain
Hospital General Universitario Reina Sofia
Murcia, , Spain
Hospital Universitario Son Espases
Palma de Mallorca, , Spain
Hospital Universitaro y Politecnico La Fe
Valencia, , Spain
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Tao-Yuan General Hospital
Taoyuan, , Taiwan
Kaohsiung Veterans General Hospital
Zuo Ying Qu, , Taiwan
Acibadem University School of Medicine Atakent Hospital
Trabzon, , Turkey (Türkiye)
Ormeau Clinical Trials Limited
Belfast, , United Kingdom
Lakeside Healthcare
Corby, , United Kingdom
CPS Research
Glasgow, , United Kingdom
Countries
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References
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Streinu-Cercel A, Castagna A, Chang SC, Chen YS, Koullias Y, Mozaffarian A, Hyland RH, Humeniuk R, Caro L, Davies S, Rodriguez L, Hedskog C, Chen S, Etchevers K, Behenna-Renton N, Llewellyn J, Osinusi A, Duff F, Barrat Hernandez A, McNally D, Simon-Campos JA, Leal FE, Fouche LF, Gonzalez Del Castillo JM. Efficacy and Safety of Obeldesivir in High-Risk Nonhospitalized Patients with COVID-19 (BIRCH): a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study. Clin Infect Dis. 2025 Jul 22:ciaf406. doi: 10.1093/cid/ciaf406. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2022-002741-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-611-6273
Identifier Type: -
Identifier Source: org_study_id