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

COVID-19 Clinical Trial

— BIRCH  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05603143
• Other study ID #: GS-US-611-6273
• Secondary ID: 2022-002741-18
• Status: Terminated
• Phase: Phase 3
• Start date: November 5, 2022
• Est. completion date: November 7, 2023

Study information

• Verified date: November 2023
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical study is to test how well the study drug, obeldesivir (formerly 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 468
• Est. completion date: November 7, 2023
• Est. primary completion date: November 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Obeldesivir
Tablets administered orally without regard to food.
• Obeldesivir Placebo
Placebo tablets administered orally without regard to food.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina da Universidade Federal de Minas Gerais	Belo Horizonte - MG
Brazil	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
Bulgaria	Multiprofile Hospital for Active Treatment Puls AD, Department of Internal Diseases	Blagoevgrad
Bulgaria	Medical Center Asklepii OOD	Dupnitsa
Bulgaria	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	Diagnostic Consultative Center 1 - Lon EOOD	Lom
Bulgaria	Medical Center Hera EOOD, Montana	Montana
Bulgaria	Multiprofile Hospital for Active Treatment Dr. Stamen Iliev AD, Department of Pneumology Phthisiatrics	Montana
Bulgaria	Medical Center Medconsult Pleven OOD	Pleven
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	Multiprofile Hospital for Active Treatment - Samokov EOOD, Department of Internal Diseases	Samokov
Bulgaria	Medical Center Unimed EOOD	Sevlievo
Bulgaria	Diagnostic and Consulting Center Aleksandrovska EOOD	Sofia
Bulgaria	Diagnostic Consultative Center XX - Sofia EOOD	Sofia
Bulgaria	Medical Center Hera EOOD	Sofia
Bulgaria	Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa EOOD, Department of Pneumology	Vratsa
Canada	Hamilton Medical Research Group	Hamilton
Canada	Dr. Anil K. Gupta Medicine Professional Corporation	Toronto
Canada	Vancouver ID Research and Care Centre Society	Vancouver
France	CHU de Montpellier-Hopital La Colombiere	Montpellier
France	Hopital Pitie Salpetriere	Paris Cedex 13
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Italy	Unita Operativa Di Malattie Infettive Ospedale San Raffaele S.r.l.	Milano
Japan	IUHW Narita Hospital	Chibaken
Japan	Okayama University Hospital	Okayama
Japan	Suita Municipal Hospital	Suita
Korea, Republic of	ChungNam National University Hospital	Daejeon
Korea, Republic of	Chonnam National University Bitgoeul Hospital	Gwangju
Korea, Republic of	Korea University Guro Hospital	Seoul
Mexico	Panamerican Clinical Research Mexico S.A. de C.V.	Col. El Salitre Juriquilla
Mexico	Neurociencias Estudios Clinicos S.C.	Culiacan Sinaloa
Mexico	PanAmerican Clinical Research Mexico S.A de C.V.	Guadalajara
Mexico	EME RED Hospitalaria	Merida
Mexico	Kohler & Milstein Research S.A de C.V.	Mérida
Mexico	Clinstile, S.A. De C.V.	Mexico City
Mexico	Oaxaca Site Management Organization S.C.	Oaxaca
Mexico	FAICIC S. de R.L. de C.V.	Veracruz
Poland	ClinMedica Research	Skierniewice	Lodzkie
Poland	Ginemedica OVO 21	Wroclaw
Poland	ETG Lodz	Zgierz
Portugal	Hospital CUF Descobertas	Lisboa
Portugal	Centro Hospitalar de Entre Douro e Vouga - Hospital de Sao Sebaststiao	Santa Maria da Feira
Portugal	Hospital da Luz - Arrabida	Vila Nova de Gaia
Romania	"Prof. Dr. Matei Bals" National Institute for Infectious Diseases	Bucharest
Romania	County Hospital Caracal	Caracal
Romania	Sibiu Emergency Clinical County Hospital	Sibiu
Singapore	National Centre for Infectious Diseases, Tan Tock Seng Hospital	Singapore
South Africa	Madibeng Centre for Research	Brits
South Africa	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	Jongaie Research	Pretoria West
South Africa	Limpopo Clinical Research Initiative	Thabazimbi
South Africa	FCRN Clinical Trial Centre (Pty) Ltd	Vereeniging
Spain	Hospital Universitario Virgen de Las Nieves.	a Gudiña
Spain	Hospital General Universitario Dr. Balmis	Alicante
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	CAP La Mina	Barcelona
Spain	Hospital HM Nou Delfos	Barcelona
Spain	Hospital Universitario Virgen del Rocio	las Cabezas de San Juan
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda
Spain	Hospital General Universitario Reina Sofia	Murcia
Spain	Hospital Universitario Son Espases	Palma de Mallorca
Spain	Hospital Universitaro y Politecnico La Fe	Valencia
Taiwan	Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	Hualien City
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Tao-Yuan General Hospital	Taoyuan City
Taiwan	Kaohsiung Veterans General Hospital	Zuo Ying Qu
Turkey	Acibadem University School of Medicine Atakent Hospital	Trabzon
United Kingdom	Ormeau Clinical Trials Limited	Belfast
United Kingdom	Lakeside Healthcare	Corby
United Kingdom	CPS Research	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

Brazil,  Bulgaria,  Canada,  France,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Portugal,  Romania,  Singapore,  South Africa,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Coronavirus Disease 2019 (COVID-19)- Related Hospitalizations or All-cause Death by Day 29		First dose date up to Day 29
Secondary	Percentage Of Participants With Treatment-Emergent Adverse Events		First dose date up to Day 5 plus 30 days
Secondary	Percentage of Participants Experiencing Laboratory Abnormalities		First dose date up to Day 5 plus 30 days
Secondary	Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation		First dose date up to Day 5 plus 30 days
Secondary	Proportion of Participants With All-cause Hospitalization by Day 29		First dose date up to Day 29
Secondary	Proportion of Participants With COVID-19-related Medically Attended Visits (MAVs) or All-cause Death by Day 29		First dose date up to Day 29
Secondary	Proportion of Participants With COVID-19-related MAVs by Day 29		First dose date up to Day 29
Secondary	Proportion of Participants With All-cause Death by Day 29		First dose date up to Day 29
Secondary	Time to COVID-19 Symptom Alleviation by Day 15		First dose date up to Day 15
Secondary	Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5		Baseline, Day 5
Secondary	Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)		Day 1 and Day 5
Secondary	Pharmacokinetic (PK) Parameter: AUCtau of GS-441524	AUCtau is defined as the area under the concentration versus time curve over the dosing interval	Day 1 and Day 5
Secondary	PK Parameter: Ctau of GS-441524	Ctau is defined as the observed drug concentration at the end of the dosing interval	Day 1 and Day 5
Secondary	PK Parameter: Cmax of GS-441524	Cmax is defined as the maximum observed plasma concentration of drug	Day 1 and Day 5

External Links

•   Gilead Clinical Trials Website