A study to test a drug named remdesivir to evaluate the efficacy and safety of the drug in treating patients with COVID-19 in an outpatient setting (non-hospitalized)
- Conditions
- COVID-19MedDRA version: 23.0Level: LLTClassification code 10084382Term: Coronavirus disease 2019System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-003510-12-DK
- Lead Sponsor
- Gilead Sciences, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1264
Participants must meet all of the following inclusion criteria to be eligible for participation in this
study:
1) Willing and able to provide written informed consent, (participants = 18 years of age) or assent (participants = 12 and < 18 years of age) prior to performing study procedures. Participants aged = 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC). For participants = 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures
2) Either:
- Age = 18 years (at all sites) or aged = 12 and < 18 years of age weighing = 40 kg (where permitted according to local law and approved nationally and by the relevant IRB or IEC) with at least 1 of the following pre-existing risk factors for progression to hospitalization:
a) Chronic lung disease: chronic obstructive pulmonary disease, moderate-to-severe asthma, cystic fibrosis, pulmonary fibrosis
b) Hypertension: systemic or pulmonary
c) Cardiovascular or cerebrovascular disease: coronary artery disease, congenital heart disease, heart failure, cardiomyopathy, history of stroke, atrial fibrillation, hyperlipidemia
d) Diabetes mellitus: Type 1, type 2, or gestational
e) Obesity (BMI = 30)
f) Immunocompromised state; having a solid organ transplant, blood, or bone marrow transplant; immune deficiencies; HIV with a low CD4 cell count or not on HIV treatment; prolonged use of corticosteroids; or use of other immune weakening medicines
g) Chronic mild or moderate kidney disease
h) Chronic liver disease
i) Current cancer
j) Sickle cell disease
- OR aged = 60 years, regardless of the presence of other pre-existing risk factors for progression
3) SARS-CoV-2 infection confirmed by molecular diagnostics (nucleic acid [eg, PCR] or antigen testing) = 4 days prior to screening
4) Presence of = 1 symptom(s) consistent with COVID-19 for = 7 days prior to randomization (such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia)
5) Not currently receiving, requiring, or expected to require supplemental oxygen
6) Not currently requiring hospitalization (hospitalization defined as = 24 hours of acute care)
7) Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Protocol Appendix 3
Are the trial subjects under 18? yes
Number of subjects for this age range: 126
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1012
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 126
Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study:
1) Participation in any other clinical trial of an experimental treatment and prevention for COVID-19
2) Prior hospitalization for COVID-19 (hospitalization defined as = 24 hours of acute care)
3) Treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 or administration of any SARS-CoV-2 (or COVID-19) vaccine
4) Requiring oxygen supplementation
5) ALT or AST = 5 × upper limit of normal (ULN) at screening or within 90 days of screening Note: if per local practice only ALT is routinely measured, exclusion criteria will be evaluated on ALT alone
6) Creatinine clearance < 30 mL/min at screening or within 90 days of screening using the Cockcroft-Gault formula in participants = 18 years of age or 30 mL/min/1.73m2 at screening or within 90 days of screening using the Schwartz formula in participants < 18 years of age (see Protocol Section 6.6.1)
7) Currently breastfeeding (nursing)
8) Known hypersensitivity to the study drug, the metabolites, or formulation excipient
9) Use or planned use of exclusionary medications, refer to Protocol Section 5.4
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method