Phase
Condition
Covid-19
Treatment
Obeldesivir
Obeldesivir Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Faculdade de Medicina da Universidade Federal de Minas Gerais
Belo Horizonte - MG, 30130-100
BrazilSite Not Available
L2iP Instituto de Pesquisas Clínicas
Brasília - DF, 70200-730
BrazilSite Not Available
Hospital da PUC Campinas - Centro de Pesquisa Sao Lucas
Campinas, 13060-904
BrazilSite Not Available
Hospital do Rocio/ Maternidade e Cirurgia Nossa Senhora do Rocio
Campo Largo, 83606
BrazilSite Not Available
Centro de Pesquisa NEIMPI - Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirao Preto, 14051
BrazilSite Not Available
Centro de Pesquisa Clinica da Universidade Municipal de São Caetano do Sul (USCS)
São Caetano Do Sul - SP, 09530-905
BrazilSite Not Available
Faculdade de Medicina da Universidade Estadual Paulista-UNESP/HC da Faculdade de Medicina de Botucatu-HCFMB
São Paulo, 03272-060
BrazilSite Not Available
Multiprofile Hospital for Active Treatment Puls AD, Department of Internal Diseases
Blagoevgrad, 2700
BulgariaSite Not Available
Medical Center Asklepii OOD
Dupnitsa, 2600
BulgariaSite Not Available
Specialìzed Hosp¡tal for Active Trealment of Pneumophthisiatric Diseases Haskovo EOOD, Department of pneumology and phthisiatry
Haskovo, 6300
BulgariaSite Not Available
Medical Center Zdrave-1 OOD
Kozloduy, 3320
BulgariaSite Not Available
Diagnostic Consultative Center 1 - Lon EOOD
Lom, 3600
BulgariaSite Not Available
Medical Center Hera EOOD, Montana
Montana, 3400
BulgariaSite Not Available
Multiprofile Hospital for Active Treatment Dr. Stamen Iliev AD, Department of Pneumology Phthisiatrics
Montana, 3400
BulgariaSite Not Available
Medical Center Medconsult Pleven OOD
Pleven, 5800
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment Sveta Marina - Pleven OOD, Clinic of Anesthesiology and lntensive Care
Pleven, 5800
BulgariaSite Not Available
Diagnostic Consultative Center Sveti Georgi EOOD
Plovdiv, 4000
BulgariaSite Not Available
MHAT Sveta Karidad EAD, First Department of Anesthesiology and Intensive Care
Plovdiv, 4004
BulgariaSite Not Available
Multiprofile Hospital for Active Treatment Sveti Panteleymon EOOD, First Department of Internal Diseases
Plovdiv, 4004
BulgariaSite Not Available
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Razgrad AD, Department of pneumology and phthisiatry
Razgrad, 7200
BulgariaSite Not Available
Medical Center Prolet EOOD
Ruse, 7002
BulgariaSite Not Available
Multiprofile Hospital for Active Treatment - Samokov EOOD, Department of Internal Diseases
Samokov, 2000
BulgariaSite Not Available
Medical Center Unimed EOOD
Sevlievo, 5400
BulgariaSite Not Available
Diagnostic Consultative Center XX - Sofia EOOD
Sofia, 1618
BulgariaSite Not Available
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, 1431
BulgariaSite Not Available
Medical Center Hera EOOD
Sofia, 1510
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment Sofiamed OOD, block 2, Department of lnfectious Diseases, COVID cabinet
Sofia, 1750
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment and Emergency Medicine ,,N. l. Pirogov" EAD,Clinic of lnternal Diseases
Sofia, 1606
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD, Infectious Diseases Clinic
Stara Zagora, 6003
BulgariaSite Not Available
Medical Center Leo Clinic EOOD
Varna, 9020
BulgariaSite Not Available
Medical Center Sanador M EOOD
Vidin, 3700
BulgariaSite Not Available
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa EOOD, Department of Pneumology
Vratsa, 3000
BulgariaSite Not Available
Hamilton Medical Research Group
Hamilton, L8M 1K7
CanadaSite Not Available
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, M9V 4B4
CanadaSite Not Available
Vancouver ID Research and Care Centre Society
Vancouver, V6Z 2C9
CanadaSite Not Available
FamilyMED s.r.o.
Brno, 612 00
CzechiaSite Not Available
Neocnice Nove Mesto Morave p.o. Infekcni oddeleni
Nove Mesto na Morave, 59231
CzechiaSite Not Available
MEDISON, s.r.o.
Přeštice, 334 01
CzechiaSite Not Available
Hopital Gabriel Montpied
Clermont-Ferrand, 63000
FranceSite Not Available
Hopital St Joseph
Marseille, 13285
FranceSite Not Available
CHU de Montpellier-Hopital La Colombiere
Montpellier, 34090
FranceSite Not Available
CHU Caremeau
Nimes, 30029
FranceSite Not Available
Hopital Saint Louis
Paris, 75010
FranceSite Not Available
Hopital Pitie Salpetriere
Paris Cedex 13, 75651
FranceSite Not Available
CH de Tourcoing
Tourcoing, 59208
FranceSite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4031
HungarySite Not Available
Dipartimento di Malattie Infettive Ospedale Luigi Sacco ASST Fatebenefratelli Sacco
Milano, 20157
ItalySite Not Available
SC Malattie Infettive ASST GOM Niguarda
Milano, 20162
ItalySite Not Available
Unita Operativa Di Malattie Infettive Ospedale San Raffaele S.r.l.
Milano, 20127
ItalySite Not Available
Azienda Universitaria Federico II - UOC Malattie Infettive
Napoli, 80131
ItalySite Not Available
Divisione di Malattie Infettive Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
ItalySite Not Available
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS - U.O.C. Malattie Infettive ad Alta Intensita di Cura
Roma, 00149
ItalySite Not Available
IUHW Narita Hospital
Chibaken, 286-0124
JapanSite Not Available
Okayama University Hospital
Okayama, 700-8558
JapanSite Not Available
Suita Municipal Hospital
Suita, 564-8567
JapanSite Not Available
ChungNam National University Hospital
Daejeon, 35015
Korea, Republic ofSite Not Available
Chonnam National University Bitgoeul Hospital
Gwangju, 61748
Korea, Republic ofSite Not Available
Chonnam National University Hospital
Gwangju, 61469
Korea, Republic ofSite Not Available
Hallym University Kangdong Sacred Heart Hospital
Seoul, 05355
Korea, Republic ofSite Not Available
Korea University Guro Hospital
Seoul, 152-703
Korea, Republic ofSite Not Available
Seoul Medical Center
Seoul, 02053
Korea, Republic ofSite Not Available
Centro Regional de Infectologia del Norte de Mexico
Chihuahua, 31000
MexicoSite Not Available
Panamerican Clinical Research Mexico S.A. de C.V.
Col. El Salitre Juriquilla, 13030
MexicoSite Not Available
Neurociencias Estudios Clinicos S.C.
Culiacan Sinaloa, 80020
MexicoSite Not Available
PanAmerican Clinical Research Mexico S.A de C.V.
Guadalajara, 44670
MexicoSite Not Available
EME RED Hospitalaria
Merida, 97000
MexicoSite Not Available
Clinstile, S.A. De C.V.
Mexico City, 06700
MexicoSite Not Available
Sociedad Administradora de Servicios de Salud, S.C.
Morelia, 58260
MexicoSite Not Available
Kohler & Milstein Research S.A de C.V.
Mérida, 97070
MexicoSite Not Available
Oaxaca Site Management Organization S.C.
Oaxaca, 68000
MexicoSite Not Available
FAICIC S. de R.L. de C.V.
Veracruz, 91900
MexicoSite Not Available
ClinMedica Research
Skierniewice, Lodzkie 96-100
PolandSite Not Available
Centrum Medyczne Pulawska Sp. z o.o
Piaseczno, 05500
PolandSite Not Available
Provita Poliklinika
Warszawa, 02-091
PolandSite Not Available
Centrum Badan Klinicznych JCI
Wroclaw, 50-349
PolandSite Not Available
Ginemedica OVO 21
Wroclaw, 50414
PolandSite Not Available
ETG Lodz
Zgierz, 95-100
PolandSite Not Available
Hospital Senhora da Oliveira - Guimareas EPE
Braga, 4835-044
PortugalSite Not Available
Hospital CUF Descobertas
Lisboa, 1998-018
PortugalSite Not Available
Centro Hospitalar Universitario de Santo Antonio E.P.E
Porto, 4099-001
PortugalSite Not Available
Centro Hospitalar de Entre Douro e Vouga - Hospital de Sao Sebaststiao
Santa Maria da Feira, 4520-211
PortugalSite Not Available
Hospital da Luz - Arrabida
Vila Nova de Gaia, 4099-346
PortugalSite Not Available
"Prof. Dr. Matei Bals" National Institute for Infectious Diseases
Bucharest, 021105
RomaniaSite Not Available
County Hospital Caracal
Caracal, 235200
RomaniaSite Not Available
Sibiu Emergency Clinical County Hospital
Sibiu, 550253
RomaniaSite Not Available
National Centre for Infectious Diseases, Tan Tock Seng Hospital
Singapore, 308433
SingaporeSite Not Available
National University Hospital
Singapore, 119228
SingaporeSite Not Available
Madibeng Centre for Research
Brits, 0250
South AfricaSite Not Available
Clinresco Centres (Pty) Ltd
City Of Johannesburg, 1619
South AfricaSite Not Available
Synapta Clinical Research Centre
Durban, 4001
South AfricaSite Not Available
Perinatal HIV Research Unit (PHRU)
Johannesburg, 2013
South AfricaSite Not Available
Setshaba Research Centre
Limpopo, 0470
South AfricaSite Not Available
Global Clinical Trials
Pretoria, 0001
South AfricaSite Not Available
Jongaie Research
Pretoria West, 0183
South AfricaSite Not Available
Limpopo Clinical Research Initiative
Thabazimbi, 0380
South AfricaSite Not Available
FCRN Clinical Trial Centre (Pty) Ltd
Vereeniging, 1938
South AfricaSite Not Available
Hospital General Universitario Dr. Balmis
Alicante, 3010
SpainSite Not Available
Hospital Universitari Germans Trias i Pujol
Badalona, 08916
SpainSite Not Available
CAP La Mina
Barcelona, 8007
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona, 8036
SpainSite Not Available
Hospital HM Nou Delfos
Barcelona, 8023
SpainSite Not Available
Hospital Universitario de Bellvitge
Barcelona, 8907
SpainSite Not Available
Hospital del Mar
Barcelona, 08003
SpainSite Not Available
Hospital General Universitario De Elche
Elche, 03202
SpainSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario Infanta Leonor
Madrid, 28031
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, 28222
SpainSite Not Available
Hospital Costa Del Sol
Marbella, 29603
SpainSite Not Available
Hospital General Universitario Reina Sofia
Murcia, 30003
SpainSite Not Available
Hospital Universitario Son Espases
Palma de Mallorca, 07120
SpainSite Not Available
Hospital Universitaro y Politecnico La Fe
Valencia, 46016
SpainSite Not Available
Hospital Clinico Universitario de Valladolid
Valladolid, 47005
SpainSite Not Available
Hospital Universitario A Coruña
a Coruña, 15006
SpainSite Not Available
Hospital Universitario Virgen de Las Nieves.
a Gudiña, 32540
SpainSite Not Available
Hospital Universitario Virgen del Rocio
las Cabezas de San Juan, 41730
SpainSite Not Available
Hopitaux Universitaires de Geneve (HUG)
Geneve 14, 1205
SwitzerlandSite Not Available
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, 970
TaiwanSite Not Available
Far Eastern Memorial Hospital
New Taipei City, 22060
TaiwanSite Not Available
China Medical University Hospital
Taichung, 40447
TaiwanSite Not Available
Chi Mei Medical Center
Tainan City, 710
TaiwanSite Not Available
National Taiwan University Hospital
Taipei City, 100
TaiwanSite Not Available
Chang Gung Memorial Hospital (CGMH)
Taoyuan, 333
TaiwanSite Not Available
Tao-Yuan General Hospital
Taoyuan City, 320
TaiwanSite Not Available
Kaohsiung Veterans General Hospital
Zuo Ying Qu, 813
TaiwanSite Not Available
Izmir Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
Konak, 35170
TurkeySite Not Available
Cukurova University Medical Faculty Balcali Hospital
Nilüfer, 16265
TurkeySite Not Available
Acibadem University School of Medicine Atakent Hospital
Trabzon, 61030
TurkeySite Not Available
Karadeniz Technical University Faculty of Medicine
Trabzon, 61080
TurkeySite Not Available
Ormeau Clinical Trials Limited
Belfast, BT7 2EB
United KingdomSite Not Available
Lakeside Healthcare
Corby, NN17 2UR
United KingdomSite Not Available
CPS Research
Glasgow, G20 0XA
United KingdomSite Not Available
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