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

December 13, 2024 updated by: Gilead Sciences

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

468

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte - MG, Brazil, 30130-100
        • Faculdade de Medicina da Universidade Federal de Minas Gerais
      • Brasília - DF, Brazil, 70200-730
        • L2IP Instituto de Pesquisas Clinicas
      • São Caetano Do Sul - SP, Brazil, 09530-905
        • Centro de Pesquisa Clinica da Universidade Municipal de São Caetano do Sul (USCS)
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Multiprofile Hospital for Active Treatment Puls AD, Department of Internal Diseases
      • Dupnitsa, Bulgaria, 2600
        • Medical Center Asklepii OOD
      • Haskovo, Bulgaria, 6300
        • Specialìzed Hosp¡tal for Active Trealment of Pneumophthisiatric Diseases Haskovo EOOD, Department of pneumology and phthisiatry
      • Kozloduy, Bulgaria, 3320
        • Medical Center Zdrave-1 OOD
      • Lom, Bulgaria, 3600
        • Diagnostic Consultative Center 1 - Lon EOOD
      • Montana, Bulgaria, 3400
        • Medical Center Hera EOOD, Montana
      • Montana, Bulgaria, 3400
        • Multiprofile Hospital for Active Treatment Dr. Stamen Iliev AD, Department of Pneumology Phthisiatrics
      • Pleven, Bulgaria, 5800
        • Medical center Medconsult Pleven OOD
      • Plovdiv, Bulgaria, 4000
        • Diagnostic Consultative Center Sveti Georgi EOOD
      • Plovdiv, Bulgaria, 4004
        • 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
      • Ruse, Bulgaria, 7002
        • Medical Center Prolet EOOD
      • Samokov, Bulgaria, 2000
        • Multiprofile Hospital for Active Treatment - Samokov EOOD, Department of Internal Diseases
      • Sevlievo, Bulgaria, 5400
        • Medical Center Unimed Eood
      • Sofia, Bulgaria, 1510
        • Medical Center Hera EOOD
      • Sofia, Bulgaria, 1431
        • Diagnostic and Consulting Center Aleksandrovska EOOD
      • Sofia, Bulgaria, 1618
        • Diagnostic Consultative Center XX - Sofia EOOD
      • Vratsa, Bulgaria, 3000
        • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa EOOD, Department of Pneumology
  • Canada
      • Hamilton, Canada, L8M 1K7
        • Hamilton Medical Research Group
      • Toronto, Canada, M9V 4B4
        • Dr. Anil K. Gupta Medicine Professional Corporation
      • Vancouver, Canada, V6Z 2C9
        • Vancouver ID Research and Care Centre Society
  • France
      • Montpellier, France, 34090
        • CHU de Montpellier-Hopital La Colombiere
      • Paris Cedex 13, France, 75651
        • Hôpital Pitié Salpêtrière
  • Hungary
      • Debrecen, Hungary, 4031
        • Debreceni Egyetem Klinikai Kozpont
  • Italy
      • Milano, Italy, 20127
        • Unita Operativa Di Malattie Infettive Ospedale San Raffaele S.r.l.
  • Japan
      • Chibaken, Japan, 286-0124
        • Iuhw Narita Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Suita, Japan, 564-8567
        • Suita Municipal Hospital
  • Korea, Republic of
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Gwangju, Korea, Republic of, 61748
        • Chonnam National University Bitgoeul Hospital
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
  • Mexico
      • Col. El Salitre Juriquilla, Mexico, 13030
        • Panamerican Clinical Research Mexico S.A. de C.V.
      • Culiacan Sinaloa, Mexico, 80020
        • Neurociencias Estudios Clinicos S.C.
      • Guadalajara, Mexico, 44670
        • PanAmerican Clinical Research Mexico S.A de C.V.
      • Merida, Mexico, 97000
        • Eme Red Hospitalaria
      • Mexico City, Mexico, 06700
        • Clinstile, S.A. de C.V.
      • Mérida, Mexico, 97070
        • Kohler & Milstein Research S.A de C.V.
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization S.C.
      • Veracruz, Mexico, 91900
        • FAICIC S. de R.L. de C.V.
  • Poland
      • Wroclaw, Poland, 50414
        • Ginemedica OVO 21
      • Zgierz, Poland, 95-100
        • ETG Lodz
    • Lodzkie
      • Skierniewice, Lodzkie, Poland, 96-100
        • ClinMedica Research
  • Portugal
      • Lisboa, Portugal, 1998-018
        • Hospital CUF Descobertas
      • Santa Maria da Feira, Portugal, 4520-211
        • Centro Hospitalar de Entre Douro e Vouga - Hospital de Sao Sebaststiao
      • Vila Nova de Gaia, Portugal, 4099-346
        • Hospital da Luz - Arrabida
  • Romania
      • Bucharest, Romania, 021105
        • "Prof. Dr. Matei Bals" National Institute for Infectious Diseases
      • Caracal, Romania, 235200
        • County Hospital Caracal
      • Sibiu, Romania, 550253
        • Sibiu Emergency Clinical County Hospital
  • Singapore
      • Singapore, Singapore, 308433
        • National Centre for Infectious Diseases, Tan Tock Seng Hospital
  • South Africa
      • Brits, South Africa, 0250
        • Madibeng Centre for Research
      • City Of Johannesburg, South Africa, 1619
        • Clinresco Centres (Pty) Ltd
      • Durban, South Africa, 4001
        • Synapta Clinical Research Centre
      • Johannesburg, South Africa, 2013
        • Perinatal HIV Research Unit (PHRU)
      • Pretoria, South Africa, 0001
        • Global Clinical Trials
      • Pretoria West, South Africa, 0183
        • Jongaie Research
      • Thabazimbi, South Africa, 0380
        • Limpopo Clinical Research Initiative
      • Vereeniging, South Africa, 1938
        • FCRN Clinical Trial Centre (Pty) Ltd
  • Spain
      • Alicante, Spain, 3010
        • Hospital General Universitario Dr. Balmis
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 8007
        • CAP La Mina
      • Barcelona, Spain, 8023
        • Hospital HM Nou Delfos
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Murcia, Spain, 30003
        • Hospital General Universitario Reina Sofía
      • Palma de Mallorca, Spain, 07120
        • Hospital Universitario Son Espases
      • Valencia, Spain, 46016
        • Hospital Universitaro y Politecnico La Fe
      • a Gudiña, Spain, 32540
        • Hospital Universitario Virgen de Las Nieves.
      • las Cabezas de San Juan, Spain, 41730
        • Hospital Universitario Virgen del Rocio
  • Taiwan
      • Hualien City, Taiwan, 970
        • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital
      • Taoyuan City, Taiwan, 320
        • Tao-Yuan General Hospital
      • Zuo Ying Qu, Taiwan, 813
        • Kaohsiung Veterans General Hospital
  • Turkey
      • Trabzon, Turkey, 61030
        • Acibadem University School of Medicine Atakent Hospital
  • United Kingdom
      • Belfast, United Kingdom, BT7 2EB
        • Ormeau Clinical Trials Limited
      • Corby, United Kingdom, NN17 2UR
        • Lakeside Healthcare
      • Glasgow, United Kingdom, G20 0XA
        • CPS Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obeldesivir
Participants will receive obeldesivir 350 mg orally twice daily for 5 days.
Drug: Obeldesivir
Tablets administered orally without regard to food.
Other Names:
  • GS-5245
Placebo Comparator: Placebo
Participants will receive placebo-to-match obeldesivir orally twice daily for 5 days.
Drug: Obeldesivir Placebo
Placebo tablets administered orally without regard to food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by Day 29
Time Frame: Up to Day 29
COVID-19-related hospitalization was defined as ≥ 24 hours of acute care for a reason related to COVID-19, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This included specialized acute medical care units within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization was related to COVID-19) were recorded. Percentages were rounded off.
Up to Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)
Time Frame: First dose date up to 5 Days plus 30 Days

TEAEs were defined as 1 or both of the following:

Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. Any AEs leading to premature discontinuation of study drug. Percentages were rounded off.
First dose date up to 5 Days plus 30 Days
Percentage of Participants Experiencing Laboratory Abnormalities
Time Frame: First dose date up to 5 Days plus 30 Days
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Percentages were rounded off.
First dose date up to 5 Days plus 30 Days
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
Time Frame: First dose date up to 5 Days plus 30 Days
A treatment emergent AE is defined as an AE that occurs or worsens in severity on or after the date of the first dose of study drug but no later than 30 days after the permanent discontinuation of study drug or an AE leading to discontinuation of study drug. A SAE is defined as an event that, at any dose, resulted in any of the following: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction. Percentages were rounded off.
First dose date up to 5 Days plus 30 Days
Percentage of Participants With All-Cause Hospitalization by Day 29
Time Frame: Up to Day 29
All-cause hospitalization was defined as ≥ 24 hours of acute care, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This includes specialized acute medical care units within an assisted living facility or nursing home. This does not include hospitalization for the purposes of public health and/or clinical study execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization is related to COVID-19) were recorded. Percentages were rounded off.
Up to Day 29
Percentage of Participants With COVID-19-Related Medically Attended Visits (MAVs) or All-Cause Death by Day 29
Time Frame: Up to Day 29
Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off.
Up to Day 29
Percentage of Participants With COVID-19-Related MAVs by Day 29
Time Frame: Up to Day 29
Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off.
Up to Day 29
Percentage of Participants With All-cause Death by Day 29
Time Frame: Up to Day 29
Percentages were rounded off.
Up to Day 29
Time to COVID-19 Symptom Alleviation by Day 15
Time Frame: Up to Day 15
Time to COVID-19 symptom alleviation was calculated as symptom alleviation date/time minus the first dose date/time. Symptom alleviation was evaluated for the 15 targeted symptoms using symptoms of infection with coronavirus-19 (SIC) questionnaire. The SIC questionnaire assessed all targeted symptoms, alleviation was defined as the SIC rating of 0, or at least 3 points decrease in rating from baseline, or an answer "No" to the question for at least 48 consecutive hours.
Up to Day 15
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5
Time Frame: Day 5
The mixed model for repeated measures (MMRM) was used for analysis.
Day 5
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Time Frame: Day 1, 0.75 and 2 hours postdose and Day 5 predose and 0.75 hours postdose
Day 1, 0.75 and 2 hours postdose and Day 5 predose and 0.75 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2022

Primary Completion (Actual)

November 7, 2023

Study Completion (Actual)

November 7, 2023

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-611-6273
  • 2022-002741-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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