Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness
- Registration Number
- NCT05603143
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 468
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obeldesivir Obeldesivir Participants will receive obeldesivir 350 mg orally twice daily for 5 days. Placebo Obeldesivir Placebo Participants will receive placebo-to-match obeldesivir orally twice daily for 5 days.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by Day 29 Up to 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) First dose date up to 5 Days plus 30 Days TEAEs were defined as 1 or both of the following:
Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. Any AEs leading to premature discontinuation of study drug. Percentages were rounded off.Percentage of Participants Experiencing Laboratory Abnormalities First dose date up to 5 Days plus 30 Days Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Percentages were rounded off.
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 A treatment emergent AE is defined as an AE that occurs or worsens in severity on or after the date of the first dose of study drug but no later than 30 days after the permanent discontinuation of study drug or an AE leading to discontinuation of study drug. A SAE is defined as an event that, at any dose, resulted in any of the following: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction. Percentages were rounded off.
Percentage of Participants With All-Cause Hospitalization by Day 29 Up to Day 29 All-cause hospitalization was defined as ≥ 24 hours of acute care, 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 includes specialized acute medical care units within an assisted living facility or nursing home. This does not include hospitalization for the purposes of public health and/or clinical study execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization is related to COVID-19) were recorded. Percentages were rounded off.
Percentage of Participants With COVID-19-Related Medically Attended Visits (MAVs) or All-Cause Death by Day 29 Up to Day 29 Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off.
Percentage of Participants With COVID-19-Related MAVs by Day 29 Up to Day 29 Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off.
Percentage of Participants With All-cause Death by Day 29 Up to Day 29 Percentages were rounded off.
Time to COVID-19 Symptom Alleviation by Day 15 Up to Day 15 Time to COVID-19 symptom alleviation was calculated as symptom alleviation date/time minus the first dose date/time. Symptom alleviation was evaluated for the 15 targeted symptoms using symptoms of infection with coronavirus-19 (SIC) questionnaire. The SIC questionnaire assessed all targeted symptoms, alleviation was defined as the SIC rating of 0, or at least 3 points decrease in rating from baseline, or an answer "No" to the question for at least 48 consecutive hours.
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5 Day 5 The mixed model for repeated measures (MMRM) was used for analysis.
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir) Day 1, 0.75 and 2 hours postdose and Day 5 predose and 0.75 hours postdose
Trial Locations
- Locations (81)
Hospital CUF Descobertas
🇵🇹Lisboa, Portugal
China Medical University Hospital
🇨🇳Taichung, Taiwan
Diagnostic and Consulting Center Aleksandrovska EOOD
🇧🇬Sofia, Bulgaria
Medical Center Asklepii OOD
🇧🇬Dupnitsa, Bulgaria
Faculdade de Medicina da Universidade Federal de Minas Gerais
🇧🇷Belo Horizonte - MG, Brazil
Diagnostic Consultative Center 1 - Lon EOOD
🇧🇬Lom, Bulgaria
Hamilton Medical Research Group
🇨🇦Hamilton, Canada
Medical Center Medconsult Pleven OOD
🇧🇬Pleven, Bulgaria
Multiprofile Hospital for Active Treatment Dr. Stamen Iliev AD, Department of Pneumology Phthisiatrics
🇧🇬Montana, Bulgaria
L2iP Instituto de Pesquisas Clínicas
🇧🇷Brasília - DF, Brazil
Centro de Pesquisa Clinica da Universidade Municipal de São Caetano do Sul (USCS)
🇧🇷São Caetano Do Sul - SP, Brazil
Multiprofile Hospital for Active Treatment Puls AD, Department of Internal Diseases
🇧🇬Blagoevgrad, Bulgaria
PanAmerican Clinical Research Mexico S.A de C.V.
🇲🇽Guadalajara, Mexico
EME RED Hospitalaria
🇲🇽Merida, Mexico
Jongaie Research
🇿🇦Pretoria West, South Africa
Diagnostic Consultative Center XX - Sofia EOOD
🇧🇬Sofia, Bulgaria
IUHW Narita Hospital
🇯🇵Chibaken, Japan
Dr. Anil K. Gupta Medicine Professional Corporation
🇨🇦Toronto, Canada
CHU de Montpellier-Hopital La Colombiere
🇫🇷Montpellier, France
Hospital da Luz - Arrabida
🇵🇹Vila Nova de Gaia, Portugal
County Hospital Caracal
🇷🇴Caracal, Romania
Hospital Universitario Virgen del Rocio
🇪🇸las Cabezas de San Juan, Spain
Limpopo Clinical Research Initiative
🇿🇦Thabazimbi, South Africa
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Suita Municipal Hospital
🇯🇵Suita, Japan
Kohler & Milstein Research S.A de C.V.
🇲🇽Mérida, Mexico
Madibeng Centre for Research
🇿🇦Brits, South Africa
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Ormeau Clinical Trials Limited
🇬🇧Belfast, United Kingdom
Lakeside Healthcare
🇬🇧Corby, United Kingdom
CPS Research
🇬🇧Glasgow, United Kingdom
Hopital Pitie Salpetriere
🇫🇷Paris Cedex 13, France
Vancouver ID Research and Care Centre Society
🇨🇦Vancouver, Canada
FCRN Clinical Trial Centre (Pty) Ltd
🇿🇦Vereeniging, South Africa
Specialìzed Hosp¡tal for Active Trealment of Pneumophthisiatric Diseases Haskovo EOOD, Department of pneumology and phthisiatry
🇧🇬Haskovo, Bulgaria
Medical Center Zdrave-1 OOD
🇧🇬Kozloduy, Bulgaria
Medical Center Hera EOOD, Montana
🇧🇬Montana, Bulgaria
Diagnostic Consultative Center Sveti Georgi EOOD
🇧🇬Plovdiv, Bulgaria
MHAT Sveta Karidad EAD, First Department of Anesthesiology and Intensive Care
🇧🇬Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment Sveti Panteleymon EOOD, First Department of Internal Diseases
🇧🇬Plovdiv, Bulgaria
Medical Center Prolet EOOD
🇧🇬Ruse, Bulgaria
Medical Center Unimed EOOD
🇧🇬Sevlievo, Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa EOOD, Department of Pneumology
🇧🇬Vratsa, Bulgaria
Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
Multiprofile Hospital for Active Treatment - Samokov EOOD, Department of Internal Diseases
🇧🇬Samokov, Bulgaria
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Unita Operativa Di Malattie Infettive Ospedale San Raffaele S.r.l.
🇮🇹Milano, Italy
Neurociencias Estudios Clinicos S.C.
🇲🇽Culiacan Sinaloa, Mexico
Panamerican Clinical Research Mexico S.A. de C.V.
🇲🇽Col. El Salitre Juriquilla, Mexico
Okayama University Hospital
🇯🇵Okayama, Japan
Chonnam National University Bitgoeul Hospital
🇰🇷Gwangju, Korea, Republic of
ClinMedica Research
🇵🇱Skierniewice, Lodzkie, Poland
Oaxaca Site Management Organization S.C.
🇲🇽Oaxaca, Mexico
ETG Lodz
🇵🇱Zgierz, Poland
Sibiu Emergency Clinical County Hospital
🇷🇴Sibiu, Romania
Clinresco Centres (Pty) Ltd
🇿🇦City Of Johannesburg, South Africa
Synapta Clinical Research Centre
🇿🇦Durban, South Africa
Perinatal HIV Research Unit (PHRU)
🇿🇦Johannesburg, South Africa
Global Clinical Trials
🇿🇦Pretoria, South Africa
Hospital General Universitario Dr. Balmis
🇪🇸Alicante, Spain
CAP La Mina
🇪🇸Barcelona, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Hospital Universitario Virgen de Las Nieves.
🇪🇸a Gudiña, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital HM Nou Delfos
🇪🇸Barcelona, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
🇪🇸Majadahonda, Spain
Hospital General Universitario Reina Sofia
🇪🇸Murcia, Spain
Hospital Universitaro y Politecnico La Fe
🇪🇸Valencia, Spain
Hospital Universitario Son Espases
🇪🇸Palma de Mallorca, Spain
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Tao-Yuan General Hospital
🇨🇳Taoyuan City, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Zuo Ying Qu, Taiwan
Acibadem University School of Medicine Atakent Hospital
🇹🇷Trabzon, Turkey
ChungNam National University Hospital
🇰🇷Daejeon, Korea, Republic of
National Centre for Infectious Diseases, Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
"Prof. Dr. Matei Bals" National Institute for Infectious Diseases
🇷🇴Bucharest, Romania
Clinstile, S.A. De C.V.
🇲🇽Mexico City, Mexico
FAICIC S. de R.L. de C.V.
🇲🇽Veracruz, Mexico
Ginemedica OVO 21
🇵🇱Wroclaw, Poland
Centro Hospitalar de Entre Douro e Vouga - Hospital de Sao Sebaststiao
🇵🇹Santa Maria da Feira, Portugal
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
🇨🇳Hualien City, Taiwan