A Multicenter, Adaptive, Randomised Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Version for Eurpean Union/United Kingdom Sites

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

1. Admitted to a hospital with synmptoms suggestive of COVID-19 infection
2. Subject (or legally authorised representative) provides informed consent prior to initiation of any study procedures
3. Subject (or legally authorised representative) understands and agrees to comply wiht planned study procedures
4.Male or non-pregnant female adult = 18 years of age at time of enrollment
5. Has laboratory - confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen as documented by either of the following: PCR positive in sample collected < 72 hours prior to randomisation OR PCR positive in sample collected = 72 hours prior to randomisation, documented inabilty to obtain a repeat sample (e.g. due to lack of testing supplies limited testing capacity, results taking > 24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection
6. Illness of any duaration, and at least one of the following:
Radiographic infiltrates by imagin (chest X-ray, CT-scanm etc.) OR SpO2 = 94% on room air, OR Requiring supplemental oxygen, OR Requiring mechanical ventilation
7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not incluidng hormonal contraception from the time of screening through Day 29
8. Agrees to not participate in another clinical trial for treatment of COVID-19 or SARS-CoV-2 thorugh Day 29

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

1. ALT/AST > 5 times the upper limit of normal
2. Estimated glumerular filtration rate (eGFR) < 30 ml/min (inlcuding patientes receiving hemodialysis or hemofiltration)
3. Pregnancy or breast feeding
4. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours
5. Allergy to any study medication

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

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