Adaptive COVID-19 treatment trial in the EU & UK

Phase 3

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN13035264
• Lead Sponsor: niversity of Minnesota

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32445440/ (added 14/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-24
• Study Completion: 2020-08-30
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1063

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. Subject (or legally authorized representative) understands and agrees to comply with 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 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:
6.1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
6.2. Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air, OR
6.3. Requiring supplemental oxygen, OR
6.4. 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. through Day 29

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 breastfeeding
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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Time to recovery: day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale:<br> 1. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care<br> 2. Not hospitalized, limitation on activities and/or requiring home oxygen<br> 3. Not hospitalized, no limitations on activities<br> Measured from Day 1 to Day 29<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Clinical status measured using an eight-category ordinal scale from Day 3 to Day 29<br> 2. Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) measured using patients’ medical records from Day 1 to Day 29<br> 3. Cumulative incidence of serious adverse events (SAEs) measured using patients’ medical records from Day 1 to Day 29<br> 4. Duration of hospitalization measured using patients’ medical records from Day 1 to Day 29<br> 5. 14-day mortality measured using patients’ medical records from Day 1 to Day 15<br> 6. 29-day mortality measured using patients’ medical records from Day 1 to Day 29<br>