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

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 (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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: Obeldesivir; Drug: Obeldesivir Placebo

• Study Type: Interventional
• Enrollment (Actual): 468
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gilead Clinical Study Information Center; Phone Number: 1-833-445-3230 (GILEAD-0); Email: GileadClinicalTrials@gilead.com

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
    • Hopital Pitie Salpetriere
• 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
    • Köhler & 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

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obeldesivir; Participants will receive obeldesivir 350 mg 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 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	Time Frame
Proportion of Coronavirus Disease 2019 (COVID-19)- Related Hospitalizations or All-cause Death by Day 29	First dose date up to Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Of Participants With Treatment-Emergent Adverse Events		First dose date up to Day 5 plus 30 days
Proportion of Participants With All-cause Hospitalization by Day 29		First dose date up to Day 29
Proportion of Participants With COVID-19-related Medically Attended Visits (MAVs) or All-cause Death by Day 29		First dose date up to Day 29
Proportion of Participants With COVID-19-related MAVs by Day 29		First dose date up to Day 29
Percentage of Participants Experiencing Laboratory Abnormalities		First dose date up to Day 5 plus 30 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation		First dose date up to Day 5 plus 30 days
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5		Baseline, Day 5
Proportion of Participants With All-cause Death by Day 29		First dose date up to Day 29
Time to COVID-19 Symptom Alleviation by Day 15		First dose date up to Day 15
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)		Day 1 and Day 5
Pharmacokinetic (PK) Parameter: AUCtau of GS-441524	AUCtau is defined as the area under the concentration versus time curve over the dosing interval	Day 1 and Day 5
PK Parameter: Ctau of GS-441524	Ctau is defined as the observed drug concentration at the end of the dosing interval	Day 1 and Day 5
PK Parameter: Cmax of GS-441524	Cmax is defined as the maximum observed plasma concentration of drug	Day 1 and Day 5

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

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): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• 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