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

Phase 3TerminatedNCT05603143

Gilead Sciences468 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

468

Conditions

COVID-19

Interventions

ObeldesivirDRUG

Tablets administered orally without regard to food.

Obeldesivir PlaceboDRUG

Placebo tablets administered orally without regard to food.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (81)

Outcomes

Primary Outcomes

Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by 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.

Time frame: Up to Day 29

Secondary Outcomes

Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)

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.

Time frame: First dose date up to 5 Days plus 30 Days

Percentage of Participants Experiencing Laboratory Abnormalities

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.

Time frame: First dose date up to 5 Days plus 30 Days

Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation

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.

Data from ClinicalTrials.gov

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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, Brazil

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

...and 71 more locations

Time frame: First dose date up to 5 Days plus 30 Days

Percentage of Participants With All-Cause Hospitalization by 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.

Time frame: Up to Day 29

Percentage of Participants With COVID-19-Related Medically Attended Visits (MAVs) or All-Cause Death by 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.

Time frame: Up to Day 29

Percentage of Participants With COVID-19-Related MAVs by Day 29

Time frame: Up to Day 29

Percentage of Participants With All-cause Death by Day 29

Percentages were rounded off.

Time frame: Up to Day 29

Time to COVID-19 Symptom Alleviation by 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.

Time frame: Up to Day 15

Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5

The mixed model for repeated measures (MMRM) was used for analysis.

Time frame: Day 5

Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)

Time frame: Day 1, 0.75 and 2 hours postdose and Day 5 predose and 0.75 hours postdose