Clinical trial NCT05603143: Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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.

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 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.

Primary outcomes:
measure: Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by Day 29
timeFrame: Up to Day 29
Secondary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)
timeFrame: First dose date up to 5 Days plus 30 Days
measure: Percentage of Participants Experiencing Laboratory Abnormalities
timeFrame: First dose date up to 5 Days plus 30 Days
measure: Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
timeFrame: First dose date up to 5 Days plus 30 Days
measure: Percentage of Participants With All-Cause Hospitalization by Day 29
timeFrame: Up to Day 29
measure: Percentage of Participants With COVID-19-Related Medically Attended Visits (MAVs) or All-Cause Death by Day 29
timeFrame: Up to Day 29
measure: Percentage of Participants With COVID-19-Related MAVs by Day 29
timeFrame: Up to Day 29
measure: Percentage of Participants With All-cause Death by Day 29
timeFrame: Up to Day 29
measure: Time to COVID-19 Symptom Alleviation by Day 15
timeFrame: Up to Day 15
measure: Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5
timeFrame: Day 5
measure: Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
timeFrame: Day 1, 0.75 and 2 hours postdose and Day 5 predose and 0.75 hours postdose
Other outcomes:
Locations:
city: Belo Horizonte - MG
country: Brazil
facility: Faculdade de Medicina da Universidade Federal de Minas Gerais
city: Brasília - DF
country: Brazil
facility: L2iP Instituto de Pesquisas Clínicas
city: São Caetano Do Sul - SP
country: Brazil
facility: Centro de Pesquisa Clinica da Universidade Municipal de São Caetano do Sul (USCS)
city: Blagoevgrad
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Puls AD, Department of Internal Diseases
city: Dupnitsa
country: Bulgaria
facility: Medical Center Asklepii OOD
city: Haskovo
country: Bulgaria
facility: Specialìzed Hosp¡tal for Active Trealment of Pneumophthisiatric Diseases Haskovo EOOD, Department of pneumology and phthisiatry
city: Kozloduy
country: Bulgaria
facility: Medical Center Zdrave-1 OOD
city: Lom
country: Bulgaria
facility: Diagnostic Consultative Center 1 - Lon EOOD
city: Montana
country: Bulgaria
facility: Medical Center Hera EOOD, Montana
city: Montana
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Dr. Stamen Iliev AD, Department of Pneumology Phthisiatrics
city: Pleven
country: Bulgaria
facility: Medical Center Medconsult Pleven OOD
city: Plovdiv
country: Bulgaria
facility: Diagnostic Consultative Center Sveti Georgi EOOD
city: Plovdiv
country: Bulgaria
facility: MHAT Sveta Karidad EAD, First Department of Anesthesiology and Intensive Care
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sveti Panteleymon EOOD, First Department of Internal Diseases
city: Ruse
country: Bulgaria
facility: Medical Center Prolet EOOD
city: Samokov
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Samokov EOOD, Department of Internal Diseases
city: Sevlievo
country: Bulgaria
facility: Medical Center Unimed EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic and Consulting Center Aleksandrovska EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center XX - Sofia EOOD
city: Vratsa
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa EOOD, Department of Pneumology
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group
city: Toronto
country: Canada
facility: Dr. Anil K. Gupta Medicine Professional Corporation
city: Vancouver
country: Canada
facility: Vancouver ID Research and Care Centre Society
city: Montpellier
country: France
facility: CHU de Montpellier-Hopital La Colombiere
city: Paris Cedex 13
country: France
facility: Hopital Pitie Salpetriere
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Milano
country: Italy
facility: Unita Operativa Di Malattie Infettive Ospedale San Raffaele S.r.l.
city: Chibaken
country: Japan
facility: IUHW Narita Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Suita
country: Japan
facility: Suita Municipal Hospital
city: Daejeon
country: Korea, Republic of
facility: ChungNam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Bitgoeul Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Col. El Salitre Juriquilla
country: Mexico
facility: Panamerican Clinical Research Mexico S.A. de C.V.
city: Culiacan Sinaloa
country: Mexico
facility: Neurociencias Estudios Clinicos S.C.
city: Guadalajara
country: Mexico
facility: PanAmerican Clinical Research Mexico S.A de C.V.
city: Merida
country: Mexico
facility: EME RED Hospitalaria
city: Mexico City
country: Mexico
facility: Clinstile, S.A. De C.V.
city: Mérida
country: Mexico
facility: Kohler & Milstein Research S.A de C.V.
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C.
city: Veracruz
country: Mexico
facility: FAICIC S. de R.L. de C.V.
city: Skierniewice
country: Poland
facility: ClinMedica Research
state: Lodzkie
city: Wroclaw
country: Poland
facility: Ginemedica OVO 21
city: Zgierz
country: Poland
facility: ETG Lodz
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas
city: Santa Maria da Feira
country: Portugal
facility: Centro Hospitalar de Entre Douro e Vouga - Hospital de Sao Sebaststiao
city: Vila Nova de Gaia
country: Portugal
facility: Hospital da Luz - Arrabida
city: Bucharest
country: Romania
facility: "Prof. Dr. Matei Bals" National Institute for Infectious Diseases
city: Caracal
country: Romania
facility: County Hospital Caracal
city: Sibiu
country: Romania
facility: Sibiu Emergency Clinical County Hospital
city: Singapore
country: Singapore
facility: National Centre for Infectious Diseases, Tan Tock Seng Hospital
city: Brits
country: South Africa
facility: Madibeng Centre for Research
city: City Of Johannesburg
country: South Africa
facility: Clinresco Centres (Pty) Ltd
city: Durban
country: South Africa
facility: Synapta Clinical Research Centre
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit (PHRU)
city: Pretoria West
country: South Africa
facility: Jongaie Research
city: Pretoria
country: South Africa
facility: Global Clinical Trials
city: Thabazimbi
country: South Africa
facility: Limpopo Clinical Research Initiative
city: Vereeniging
country: South Africa
facility: FCRN Clinical Trial Centre (Pty) Ltd
city: a Gudiña
country: Spain
facility: Hospital Universitario Virgen de Las Nieves.
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: CAP La Mina
city: Barcelona
country: Spain
facility: Hospital HM Nou Delfos
city: las Cabezas de San Juan
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofia
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Valencia
country: Spain
facility: Hospital Universitaro y Politecnico La Fe
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Tao-Yuan General Hospital
city: Zuo Ying Qu
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Trabzon
country: Turkey
facility: Acibadem University School of Medicine Atakent Hospital
city: Belfast
country: United Kingdom
facility: Ormeau Clinical Trials Limited
city: Corby
country: United Kingdom
facility: Lakeside Healthcare
city: Glasgow
country: United Kingdom
facility: CPS Research
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: