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

Last updated: December 13, 2024
Sponsor: Gilead Sciences
Overall Status: Terminated

Phase

3

Condition

Covid-19

Treatment

Obeldesivir

Obeldesivir Placebo

Clinical Study ID

NCT05603143
GS-US-611-6273
2022-002741-18
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Willing and able to provide written informed consent.

  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed byPCR or an approved alternative assay (eg. Rapid Antigen Test) ≤ 5 days beforerandomization. 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 atany point) for progression to severe disease.

Exclusion

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 ofCOVID-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 (includingbooster dose) <120 days before randomization.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 468
Treatment Group(s): 2
Primary Treatment: Obeldesivir
Phase: 3
Study Start date:
November 05, 2022
Estimated Completion Date:
November 07, 2023

Connect with a study center

  • Faculdade de Medicina da Universidade Federal de Minas Gerais

    Belo Horizonte - MG, 30130-100
    Brazil

    Site Not Available

  • L2iP Instituto de Pesquisas Clínicas

    Brasília - DF, 70200-730
    Brazil

    Site Not Available

  • Hospital da PUC Campinas - Centro de Pesquisa Sao Lucas

    Campinas, 13060-904
    Brazil

    Site Not Available

  • Hospital do Rocio/ Maternidade e Cirurgia Nossa Senhora do Rocio

    Campo Largo, 83606
    Brazil

    Site Not Available

  • Centro de Pesquisa NEIMPI - Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

    Ribeirao Preto, 14051
    Brazil

    Site Not Available

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

    São Caetano Do Sul - SP, 09530-905
    Brazil

    Site Not Available

  • Faculdade de Medicina da Universidade Estadual Paulista-UNESP/HC da Faculdade de Medicina de Botucatu-HCFMB

    São Paulo, 03272-060
    Brazil

    Site Not Available

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

    Blagoevgrad, 2700
    Bulgaria

    Site Not Available

  • Medical Center Asklepii OOD

    Dupnitsa, 2600
    Bulgaria

    Site Not Available

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

    Haskovo, 6300
    Bulgaria

    Site Not Available

  • Medical Center Zdrave-1 OOD

    Kozloduy, 3320
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center 1 - Lon EOOD

    Lom, 3600
    Bulgaria

    Site Not Available

  • Medical Center Hera EOOD, Montana

    Montana, 3400
    Bulgaria

    Site Not Available

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

    Montana, 3400
    Bulgaria

    Site Not Available

  • Medical Center Medconsult Pleven OOD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Sveta Marina - Pleven OOD, Clinic of Anesthesiology and lntensive Care

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center Sveti Georgi EOOD

    Plovdiv, 4000
    Bulgaria

    Site Not Available

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

    Plovdiv, 4004
    Bulgaria

    Site Not Available

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

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Razgrad AD, Department of pneumology and phthisiatry

    Razgrad, 7200
    Bulgaria

    Site Not Available

  • Medical Center Prolet EOOD

    Ruse, 7002
    Bulgaria

    Site Not Available

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

    Samokov, 2000
    Bulgaria

    Site Not Available

  • Medical Center Unimed EOOD

    Sevlievo, 5400
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center XX - Sofia EOOD

    Sofia, 1618
    Bulgaria

    Site Not Available

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Medical Center Hera EOOD

    Sofia, 1510
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Sofiamed OOD, block 2, Department of lnfectious Diseases, COVID cabinet

    Sofia, 1750
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine ,,N. l. Pirogov" EAD,Clinic of lnternal Diseases

    Sofia, 1606
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD, Infectious Diseases Clinic

    Stara Zagora, 6003
    Bulgaria

    Site Not Available

  • Medical Center Leo Clinic EOOD

    Varna, 9020
    Bulgaria

    Site Not Available

  • Medical Center Sanador M EOOD

    Vidin, 3700
    Bulgaria

    Site Not Available

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

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • Hamilton Medical Research Group

    Hamilton, L8M 1K7
    Canada

    Site Not Available

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Toronto, M9V 4B4
    Canada

    Site Not Available

  • Vancouver ID Research and Care Centre Society

    Vancouver, V6Z 2C9
    Canada

    Site Not Available

  • FamilyMED s.r.o.

    Brno, 612 00
    Czechia

    Site Not Available

  • Neocnice Nove Mesto Morave p.o. Infekcni oddeleni

    Nove Mesto na Morave, 59231
    Czechia

    Site Not Available

  • MEDISON, s.r.o.

    Přeštice, 334 01
    Czechia

    Site Not Available

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • Hopital St Joseph

    Marseille, 13285
    France

    Site Not Available

  • CHU de Montpellier-Hopital La Colombiere

    Montpellier, 34090
    France

    Site Not Available

  • CHU Caremeau

    Nimes, 30029
    France

    Site Not Available

  • Hopital Saint Louis

    Paris, 75010
    France

    Site Not Available

  • Hopital Pitie Salpetriere

    Paris Cedex 13, 75651
    France

    Site Not Available

  • CH de Tourcoing

    Tourcoing, 59208
    France

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4031
    Hungary

    Site Not Available

  • Dipartimento di Malattie Infettive Ospedale Luigi Sacco ASST Fatebenefratelli Sacco

    Milano, 20157
    Italy

    Site Not Available

  • SC Malattie Infettive ASST GOM Niguarda

    Milano, 20162
    Italy

    Site Not Available

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

    Milano, 20127
    Italy

    Site Not Available

  • Azienda Universitaria Federico II - UOC Malattie Infettive

    Napoli, 80131
    Italy

    Site Not Available

  • Divisione di Malattie Infettive Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124
    Italy

    Site Not Available

  • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS - U.O.C. Malattie Infettive ad Alta Intensita di Cura

    Roma, 00149
    Italy

    Site Not Available

  • IUHW Narita Hospital

    Chibaken, 286-0124
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Site Not Available

  • Suita Municipal Hospital

    Suita, 564-8567
    Japan

    Site Not Available

  • ChungNam National University Hospital

    Daejeon, 35015
    Korea, Republic of

    Site Not Available

  • Chonnam National University Bitgoeul Hospital

    Gwangju, 61748
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju, 61469
    Korea, Republic of

    Site Not Available

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul, 05355
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 152-703
    Korea, Republic of

    Site Not Available

  • Seoul Medical Center

    Seoul, 02053
    Korea, Republic of

    Site Not Available

  • Centro Regional de Infectologia del Norte de Mexico

    Chihuahua, 31000
    Mexico

    Site Not Available

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

    Col. El Salitre Juriquilla, 13030
    Mexico

    Site Not Available

  • Neurociencias Estudios Clinicos S.C.

    Culiacan Sinaloa, 80020
    Mexico

    Site Not Available

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

    Guadalajara, 44670
    Mexico

    Site Not Available

  • EME RED Hospitalaria

    Merida, 97000
    Mexico

    Site Not Available

  • Clinstile, S.A. De C.V.

    Mexico City, 06700
    Mexico

    Site Not Available

  • Sociedad Administradora de Servicios de Salud, S.C.

    Morelia, 58260
    Mexico

    Site Not Available

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

    Mérida, 97070
    Mexico

    Site Not Available

  • Oaxaca Site Management Organization S.C.

    Oaxaca, 68000
    Mexico

    Site Not Available

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900
    Mexico

    Site Not Available

  • ClinMedica Research

    Skierniewice, Lodzkie 96-100
    Poland

    Site Not Available

  • Centrum Medyczne Pulawska Sp. z o.o

    Piaseczno, 05500
    Poland

    Site Not Available

  • Provita Poliklinika

    Warszawa, 02-091
    Poland

    Site Not Available

  • Centrum Badan Klinicznych JCI

    Wroclaw, 50-349
    Poland

    Site Not Available

  • Ginemedica OVO 21

    Wroclaw, 50414
    Poland

    Site Not Available

  • ETG Lodz

    Zgierz, 95-100
    Poland

    Site Not Available

  • Hospital Senhora da Oliveira - Guimareas EPE

    Braga, 4835-044
    Portugal

    Site Not Available

  • Hospital CUF Descobertas

    Lisboa, 1998-018
    Portugal

    Site Not Available

  • Centro Hospitalar Universitario de Santo Antonio E.P.E

    Porto, 4099-001
    Portugal

    Site Not Available

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

    Santa Maria da Feira, 4520-211
    Portugal

    Site Not Available

  • Hospital da Luz - Arrabida

    Vila Nova de Gaia, 4099-346
    Portugal

    Site Not Available

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

    Bucharest, 021105
    Romania

    Site Not Available

  • County Hospital Caracal

    Caracal, 235200
    Romania

    Site Not Available

  • Sibiu Emergency Clinical County Hospital

    Sibiu, 550253
    Romania

    Site Not Available

  • National Centre for Infectious Diseases, Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Site Not Available

  • National University Hospital

    Singapore, 119228
    Singapore

    Site Not Available

  • Madibeng Centre for Research

    Brits, 0250
    South Africa

    Site Not Available

  • Clinresco Centres (Pty) Ltd

    City Of Johannesburg, 1619
    South Africa

    Site Not Available

  • Synapta Clinical Research Centre

    Durban, 4001
    South Africa

    Site Not Available

  • Perinatal HIV Research Unit (PHRU)

    Johannesburg, 2013
    South Africa

    Site Not Available

  • Setshaba Research Centre

    Limpopo, 0470
    South Africa

    Site Not Available

  • Global Clinical Trials

    Pretoria, 0001
    South Africa

    Site Not Available

  • Jongaie Research

    Pretoria West, 0183
    South Africa

    Site Not Available

  • Limpopo Clinical Research Initiative

    Thabazimbi, 0380
    South Africa

    Site Not Available

  • FCRN Clinical Trial Centre (Pty) Ltd

    Vereeniging, 1938
    South Africa

    Site Not Available

  • Hospital General Universitario Dr. Balmis

    Alicante, 3010
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • CAP La Mina

    Barcelona, 8007
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 8036
    Spain

    Site Not Available

  • Hospital HM Nou Delfos

    Barcelona, 8023
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    Barcelona, 8907
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital General Universitario De Elche

    Elche, 03202
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor

    Madrid, 28031
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, 28222
    Spain

    Site Not Available

  • Hospital Costa Del Sol

    Marbella, 29603
    Spain

    Site Not Available

  • Hospital General Universitario Reina Sofia

    Murcia, 30003
    Spain

    Site Not Available

  • Hospital Universitario Son Espases

    Palma de Mallorca, 07120
    Spain

    Site Not Available

  • Hospital Universitaro y Politecnico La Fe

    Valencia, 46016
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47005
    Spain

    Site Not Available

  • Hospital Universitario A Coruña

    a Coruña, 15006
    Spain

    Site Not Available

  • Hospital Universitario Virgen de Las Nieves.

    a Gudiña, 32540
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    las Cabezas de San Juan, 41730
    Spain

    Site Not Available

  • Hopitaux Universitaires de Geneve (HUG)

    Geneve 14, 1205
    Switzerland

    Site Not Available

  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    Hualien City, 970
    Taiwan

    Site Not Available

  • Far Eastern Memorial Hospital

    New Taipei City, 22060
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Site Not Available

  • Chi Mei Medical Center

    Tainan City, 710
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei City, 100
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital (CGMH)

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Tao-Yuan General Hospital

    Taoyuan City, 320
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Zuo Ying Qu, 813
    Taiwan

    Site Not Available

  • Izmir Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital

    Konak, 35170
    Turkey

    Site Not Available

  • Cukurova University Medical Faculty Balcali Hospital

    Nilüfer, 16265
    Turkey

    Site Not Available

  • Acibadem University School of Medicine Atakent Hospital

    Trabzon, 61030
    Turkey

    Site Not Available

  • Karadeniz Technical University Faculty of Medicine

    Trabzon, 61080
    Turkey

    Site Not Available

  • Ormeau Clinical Trials Limited

    Belfast, BT7 2EB
    United Kingdom

    Site Not Available

  • Lakeside Healthcare

    Corby, NN17 2UR
    United Kingdom

    Site Not Available

  • CPS Research

    Glasgow, G20 0XA
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.