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

Phase 1

• Conditions: Influenza COVID-19; MedDRA version: 20.0Level: HLTClassification code 10022005Term: Influenza viral infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001052-18-ES
• Lead Sponsor: Regents of the University of Minnesota

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-07
• Study Completion: 2020-09-10
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1062

Inclusion Criteria

1. Admitted to a hospital with synmptoms suggestive of COVID-19 infection
2. Subject (or legally authorised representative) provides written 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 othe rcommercial or public health assay in any specimen collected < 72 hous prior to randomisation
6. Illness of any duaration, and at least one of the following:
Radiographic infiltrates by imagin, OR Clincial assessment (evidence of rales/crackels on exam) AND 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 antoehr clinical trial for treatment of COVID-19 or SARS-CoV-2
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 340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. ALT/AST > 5 times the upper limit of normal
2. Estimated glumerular filtration rate (eGFR) < 50 or requiring dialysis
3. Pregnancy or breast feeding
4. Anticipated 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