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

NCT05603143 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: GS-US-611-62732022-002741-18
• Study Type: interventional
• Target: 468
• Locations: 18 countries
• Sites: 81

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by 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 Outcomes (10)

• Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)

  First dose date up to 5 Days plus 30 Days

• Percentage of Participants Experiencing Laboratory Abnormalities

  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

  First dose date up to 5 Days plus 30 Days

• Percentage of Participants With All-Cause Hospitalization by Day 29

  Up to Day 29

• Percentage of Participants With COVID-19-Related Medically Attended Visits (MAVs) or All-Cause Death by Day 29

  Up to Day 29

Study Arms (2)

Obeldesivir

EXPERIMENTAL

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

Drug: Obeldesivir

Placebo

PLACEBO COMPARATOR

Participants will receive placebo-to-match obeldesivir orally twice daily for 5 days.

Drug: Obeldesivir Placebo

Interventions

Obeldesivir DRUG

Tablets administered orally without regard to food.

Also known as: GS-5245

Obeldesivir

Obeldesivir Placebo DRUG

Placebo tablets administered orally without regard to food.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (81)

Faculdade de Medicina da Universidade Federal de Minas Gerais

Belo Horizonte - MG, 30130-100, Brazil

Location

L2iP Instituto de Pesquisas Clínicas

Brasília - DF, 70200-730, Brazil

Location

Centro de Pesquisa Clinica da Universidade Municipal de São Caetano do Sul (USCS)

São Caetano Do Sul - SP, 09530-905, Brazil

Location

Multiprofile Hospital for Active Treatment Puls AD, Department of Internal Diseases

Blagoevgrad, 2700, Bulgaria

Location

Medical Center Asklepii OOD

Dupnitsa, 2600, Bulgaria

Location

Specialìzed Hosp¡tal for Active Trealment of Pneumophthisiatric Diseases Haskovo EOOD, Department of pneumology and phthisiatry

Haskovo, 6300, Bulgaria

Location

Medical Center Zdrave-1 OOD

Kozloduy, 3320, Bulgaria

Location

Diagnostic Consultative Center 1 - Lon EOOD

Lom, 3600, Bulgaria

Location

Medical Center Hera EOOD, Montana

Montana, 3400, Bulgaria

Location

Multiprofile Hospital for Active Treatment Dr. Stamen Iliev AD, Department of Pneumology Phthisiatrics

Montana, 3400, Bulgaria

Location

Medical Center Medconsult Pleven OOD

Pleven, 5800, Bulgaria

Location

Diagnostic Consultative Center Sveti Georgi EOOD

Plovdiv, 4000, Bulgaria

Location

MHAT Sveta Karidad EAD, First Department of Anesthesiology and Intensive Care

Plovdiv, 4004, Bulgaria

Location

Multiprofile Hospital for Active Treatment Sveti Panteleymon EOOD, First Department of Internal Diseases

Plovdiv, 4004, Bulgaria

Location

Medical Center Prolet EOOD

Rousse, 7002, Bulgaria

Location

Multiprofile Hospital for Active Treatment - Samokov EOOD, Department of Internal Diseases

Samokov, 2000, Bulgaria

Location

Medical Center Unimed EOOD

Sevlievo, 5400, Bulgaria

Location

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, 1431, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

Diagnostic Consultative Center XX - Sofia EOOD

Sofia, 1618, Bulgaria

Location

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa EOOD, Department of Pneumology

Vratsa, 3000, Bulgaria

Location

Hamilton Medical Research Group

Hamilton, L8M 1K7, Canada

Location

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, M9V 4B4, Canada

Location

Vancouver ID Research and Care Centre Society

Vancouver, V6Z 2C9, Canada

Location

CHU de Montpellier-Hopital La Colombiere

Montpellier, 34090, France

Location

Hopital Pitie Salpetriere

Paris, 75651, France

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4031, Hungary

Location

Unita Operativa Di Malattie Infettive Ospedale San Raffaele S.r.l.

Milan, 20127, Italy

Location

IUHW Narita Hospital

Chibaken, 286-0124, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Suita Municipal Hospital

Suita, 564-8567, Japan

Location

Panamerican Clinical Research Mexico S.A. de C.V.

Col. El Salitre Juriquilla, 13030, Mexico

Location

Neurociencias Estudios Clinicos S.C.

Culiacan Sinaloa, 80020, Mexico

Location

PanAmerican Clinical Research Mexico S.A de C.V.

Guadalajara, 44670, Mexico

Location

Clinstile, S.A. De C.V.

Mexico City, 06700, Mexico

Location

EME RED Hospitalaria

Mérida, 97000, Mexico

Location

Kohler & Milstein Research S.A de C.V.

Mérida, 97070, Mexico

Location

Oaxaca Site Management Organization S.C.

Oaxaca City, 68000, Mexico

Location

FAICIC S. de R.L. de C.V.

Veracruz, 91900, Mexico

Location

Ginemedica OVO 21

Wroclaw, 50414, Poland

Location

ETG Lodz

Zgierz, 95-100, Poland

Location

ClinMedica Research

Skierniewice, Łódź Voivodeship, 96-100, Poland

Location

Hospital CUF Descobertas

Lisbon, 1998-018, Portugal

Location

Centro Hospitalar de Entre Douro e Vouga - Hospital de Sao Sebaststiao

Santa Maria da Feira, 4520-211, Portugal

Location

Hospital da Luz - Arrabida

Vila Nova de Gaia, 4099-346, Portugal

Location

"Prof. Dr. Matei Bals" National Institute for Infectious Diseases

Bucharest, 021105, Romania

Location

County Hospital Caracal

Caracal, 235200, Romania

Location

Sibiu Emergency Clinical County Hospital

Sibiu, 550253, Romania

Location

National Centre for Infectious Diseases, Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Madibeng Centre for Research

Brits, 0250, South Africa

Location

Clinresco Centres (Pty) Ltd

City of Johannesburg, 1619, South Africa

Location

Synapta Clinical Research Centre

Durban, 4001, South Africa

Location

Perinatal HIV Research Unit (PHRU)

Johannesburg, 2013, South Africa

Location

Global Clinical Trials

Pretoria, 0001, South Africa

Location

Jongaie Research

Pretoria West, 0183, South Africa

Location

Limpopo Clinical Research Initiative

Thabazimbi, 0380, South Africa

Location

FCRN Clinical Trial Centre (Pty) Ltd

Vereeniging, 1938, South Africa

Location

ChungNam National University Hospital

Daejeon, 35015, South Korea

Location

Chonnam National University Bitgoeul Hospital

Gwangju, 61748, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Hospital Universitario Virgen de Las Nieves.

A Gudiña, 32540, Spain

Location

Hospital General Universitario Dr. Balmis

Alicante, 3010, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

CAP La Mina

Barcelona, 8007, Spain

Location

Hospital HM Nou Delfos

Barcelona, 8023, Spain

Location

Hospital Universitario Virgen del Rocio

Las Cabezas de San Juan, 41730, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, 28222, Spain

Location

Hospital General Universitario Reina Sofia

Murcia, 30003, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, 07120, Spain

Location

Hospital Universitaro y Politecnico La Fe

Valencia, 46016, Spain

Location

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, 970, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Tao-Yuan General Hospital

Taoyuan, 320, Taiwan

Location

Kaohsiung Veterans General Hospital

Zuo Ying Qu, 813, Taiwan

Location

Acibadem University School of Medicine Atakent Hospital

Trabzon, 61030, Turkey (Türkiye)

Location

Ormeau Clinical Trials Limited

Belfast, BT7 2EB, United Kingdom

Location

Lakeside Healthcare

Corby, NN17 2UR, United Kingdom

Location

CPS Research

Glasgow, G20 0XA, United Kingdom

Location

Related Publications (2)

• Hedskog C, Rodriguez L, Hu Y, Li J, Han D, Peinovich N, Martinez C, Ho PY, Perry JK, Del Castillo JMG, Koullias Y, Martin R, Hyland RH. SARS-CoV-2 Resistance Analyses From the Phase 3 BIRCH Study of Obeldesivir in High-Risk Nonhospitalized Participants With COVID-19. Antiviral Res. 2026 Jan 19:106351. doi: 10.1016/j.antiviral.2026.106351. Online ahead of print.

  PMID: 41565160 DERIVED

• 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.

  PMID: 40694627 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 2, 2022
• Study Start: November 5, 2022
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (12); FR (2); BR (3); HU (1); ME (8); ZA (8); IT (1); PL (3); PT (3); JP (3); SG (1); KR (3); TW (5); GB (3); BU (18); CA (3); TU (1); RO (3)