Study Details

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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

COVID-19

Gender

N/A

Date

November 2022 - November 2023

Study Type

INTERVENTIONAL

Study Phase

PHASE3

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

Medical Center Asklepii OOD

Dupnitsa, Bulgaria, 2600

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

Haskovo, Bulgaria, 6300

Medical Center Zdrave-1 OOD

Kozloduy, Bulgaria, 3320

Diagnostic Consultative Center 1 - Lon EOOD

Lom, Bulgaria, 3600

Medical Center Hera EOOD, Montana

Montana, Bulgaria, 3400

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

Montana, Bulgaria, 3400

Medical Center Medconsult Pleven OOD

Pleven, Bulgaria, 5800

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

Medical Center Prolet EOOD

Ruse, Bulgaria, 7002

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

Samokov, Bulgaria, 2000

Medical Center Unimed EOOD

Sevlievo, Bulgaria, 5400

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, Bulgaria, 1431

Medical Center Hera EOOD

Sofia, Bulgaria, 1510

Diagnostic Consultative Center XX - Sofia EOOD

Sofia, Bulgaria, 1618

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

Vratsa, Bulgaria, 3000

Hamilton Medical Research Group

Hamilton, Canada, L8M 1K7

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, Canada, M9V 4B4

Vancouver ID Research and Care Centre Society

Vancouver, Canada, V6Z 2C9

CHU de Montpellier-Hopital La Colombiere

Montpellier, France, 34090

Hopital Pitie Salpetriere

Paris Cedex 13, France, 75651

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4031

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

Milano, Italy, 20127

IUHW Narita Hospital

Chibaken, Japan, 286-0124

Okayama University Hospital

Okayama, Japan, 700-8558

Suita Municipal Hospital

Suita, Japan, 564-8567

ChungNam National University Hospital

Daejeon, Korea, Republic of, 35015

Chonnam National University Bitgoeul Hospital

Gwangju, Korea, Republic of, 61748

Korea University Guro Hospital

Seoul, Korea, Republic of, 152-703

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

Col. El Salitre Juriquilla, Mexico, 13030

Neurociencias Estudios Clinicos S.C.

Culiacan Sinaloa, Mexico, 80020

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

Guadalajara, Mexico, 44670

EME RED Hospitalaria

Merida, Mexico, 97000

Clinstile, S.A. De C.V.

Mexico City, Mexico, 06700

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

Mérida, Mexico, 97070

Oaxaca Site Management Organization S.C.

Oaxaca, Mexico, 68000

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

Veracruz, Mexico, 91900

ClinMedica Research

Skierniewice, Lodzkie, Poland, 96-100

Ginemedica OVO 21

Wroclaw, Poland, 50414

ETG Lodz

Zgierz, Poland, 95-100

Hospital CUF Descobertas

Lisboa, Portugal, 1998-018

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

Santa Maria da Feira, Portugal, 4520-211

Hospital da Luz - Arrabida

Vila Nova de Gaia, Portugal, 4099-346

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

Bucharest, Romania, 021105

County Hospital Caracal

Caracal, Romania, 235200

Sibiu Emergency Clinical County Hospital

Sibiu, Romania, 550253

National Centre for Infectious Diseases, Tan Tock Seng Hospital

Singapore, Singapore, 308433

Madibeng Centre for Research

Brits, South Africa, 0250

Clinresco Centres (Pty) Ltd

City Of Johannesburg, South Africa, 1619

Synapta Clinical Research Centre

Durban, South Africa, 4001

Perinatal HIV Research Unit (PHRU)

Johannesburg, South Africa, 2013

Jongaie Research

Pretoria West, South Africa, 0183

Global Clinical Trials

Pretoria, South Africa, 0001

Limpopo Clinical Research Initiative

Thabazimbi, South Africa, 0380

FCRN Clinical Trial Centre (Pty) Ltd

Vereeniging, South Africa, 1938

Hospital Universitario Virgen de Las Nieves.

a Gudiña, Spain, 32540

Hospital General Universitario Dr. Balmis

Alicante, Spain, 3010

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

CAP La Mina

Barcelona, Spain, 8007

Hospital HM Nou Delfos

Barcelona, Spain, 8023

Hospital Universitario Virgen del Rocio

las Cabezas de San Juan, Spain, 41730

Hospital Universitario Infanta Leonor

Madrid, Spain, 28031

Hospital Clinico San Carlos

Madrid, Spain, 28040

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Spain, 28222

Hospital General Universitario Reina Sofia

Murcia, Spain, 30003

Hospital Universitario Son Espases

Palma de Mallorca, Spain, 07120

Hospital Universitaro y Politecnico La Fe

Valencia, Spain, 46016

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Taiwan, 970

China Medical University Hospital

Taichung, Taiwan, 40447

National Taiwan University Hospital

Taipei City, Taiwan, 100

Tao-Yuan General Hospital

Taoyuan City, Taiwan, 320

Kaohsiung Veterans General Hospital

Zuo Ying Qu, Taiwan, 813

Acibadem University School of Medicine Atakent Hospital

Trabzon, Turkey, 61030

Ormeau Clinical Trials Limited

Belfast, United Kingdom, BT7 2EB

Lakeside Healthcare

Corby, United Kingdom, NN17 2UR

CPS Research

Glasgow, United Kingdom, G20 0XA

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

OVERVIEW