COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002741-18/HU

Gilead Sciences International Ltd. - Clinical Trials Mailbox

clinical.trials@gilead.com

2022-10-13

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Participants must meet all the following inclusion criteria to be eligible for participation in this study: 1) Aged ≥ 18 years at screening. 2) Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally and nationally approved). 3) SARS-CoV-2 infection confirmed by PCR or an alternative assay ≤ 5 days before randomization. 4) Initial onset of COVID-19 signs/symptoms ≤ 5 days before randomization with ≥ 1 sign/symptom present at randomization (not including changes in taste or smell). 5) Not currently hospitalized or requiring hospitalization. 6) Presence of ≥ 1 risk factor (if unvaccinated) or ≥ 2 risk factors (if vaccinated at any point) for progression to severe disease. Vaccinated individuals are eligible for enrollment only if it has been at least 4 months since the most recent dose, including boosters. Risk factors are the following: a. Aged ≥ 50 years. b. Current or recent (≤ 6 months prior to randomization) cancer (other than localized skin cancer). c. Have human immunodeficiency virus infection. d. Prior splenectomy. e. Prior solid organ, stem cell, or bone marrow transplant. f. Have systemic rheumatologic or dermatologic disorders. g. Use of systemic immunosuppressive agents. h. Have cerebrovascular disease. i. Have cardiovascular disease, including heart failure. j. Have chronic kidney disease (provided participant does not meet exclusion criterion 7). k. Have chronic lung disease. k.i. Interstitial lung disease k.ii. Pulmonary embolism k.iii. Pulmonary hypertension k.iv. Bronchiectasis k.v. Chronic obstructive pulmonary disease l. Have chronic liver disease. m. Have cystic fibrosis. n. Have diabetes mellitus, type 1 and/or type 2. o. Have neurodevelopmental and neurodegenerative conditions. p. Have a body mass index ≥ 25. q. Have sickle cell disease.

Exclusion criteria for participation include: 1) Anticipated access to and use of authorized or approved COVID-19 therapies during the current COVID-19 illness < 5 days after randomization (therapies include nirmatrelvir/ritonavir, molnupiravir, intravenous remdesivir [RDV, Veklury®], monoclonal antibodies). 2) Received any approved, authorized, or investigational 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. 3) Anticipated need for hospitalization < 48 hours after randomization. 4) New oxygen requirement < 24 hours before randomization. 5) Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention. 6) Cirrhosis or acute liver injury/failure. 7) Undergoing dialysis, or known history of moderate to severe renal impairment, or known CLcr < 60 mL/min (as calculated by Cockcroft-Gault) or eGFR < 60 mL/min/1.73 m² within the last 6 months. Potential participants meeting the laboratory criterion may be enrolled if test results available before dosing show that renal function no longer meets this criterion. 8) Known history of any of the following abnormal laboratory results (< 6 months before randomization) unless confirmed as resolved to not meet criteria at screening. a. Alanine aminotransferase (ALT) ≥ 5 x upper limit of normal (ULN) b. Bilirubin ≥ 5 x ULN 9) Positive urine pregnancy test at screening. 10) Breastfeeding (nursing). 11) Unwilling to use protocol-mandated birth control. 12) Known hypersensitivity to the study drug, its metabolites, or formulation excipient. 13) Requirement for ongoing therapy with or prior use of any prohibited medications.

2

Gilead Sciences, Inc.

18

100

Argentina;Brazil;Bulgaria;Canada;Colombia;Czech Republic;Denmark;France;Germany;Hungary;India;Italy;Japan;Kenya;Republic of Korea;Mexico;Peru;Philippines;Poland;Portugal;Romania;Serbia;Singapore;South Africa;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;United States

Mild disease at enrollment

1: Mild disease at enrollment

36

•Proportion of COVID-19–related hospitalization or all-cause death by Day 29

Declared number of arm (3.0) differs from found arms (2.0)

Phase 3

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