A Multicentre, Adaptive, Randomised, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalised Adults

Phase 1

• Conditions: COVID-19 (Coronavirus RNA); MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Health Care [N] - Environment and Public Health [N06]

• Registration Number: EUCTR2020-001052-18-GB
• 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: 2020-03-23
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

1.Admitted to a hospital with symptoms suggestive of COVID-19 infection.
2.Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
3.Understands and agrees to comply with planned study procedures.
4.Male or non-pregnant female adult =18 years of age at time of enrolment.
5.Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen collected < 72 hours prior to randomization.
Note – 72 hours is not necessarily time from initial diagnosis. If =72 hours since positive PCR, the PCR may be repeated to assess eligibility.
6.Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR Clinical assessment (evidence of rales/crackles 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 including hormonal contraception from the time of screening through Day 29.
8.Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. ALT/AST > 5 times the upper limit of normal.
2.Estimated glomerular 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