COVID MED Trial - Comparison Of Therapeutics for Hospitalized Patients Infected With COVID-19

• Status: Recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

In a randomized, double-blind, placebo-controlled, multi-center, Phase 2-like, investigator-directed trial, hospitalized adult patients with laboratory confirmed SARS-CoV-2 infection meeting inclusion and exclusion criteria, will be provided information on the trial, offered enrollment, and if informed consent provided, enrolled randomly in a 2:1 ratio to one of two groups: Group 1 standard care and losartan or Group 2 standard care and placebo. Patients will be followed for up to 60 days, with data collected to quantify the NCOSS over time (the primary objective), and for the trial's secondary objectives (see outcome measurements below).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bassett Healthcare
• Collaborators: Goshen Health System; Reid Health
• Treatments: Coal Tar; Hydroxychloroquine; Lopinavir; Losartan; Ritonavir

Criteria

Inclusion criteria

1. Hospitalized patient

2. Age >= 18 years

3. Able to ingest oral medication or be administered medication via gastric tube or equivalent

4. Laboratory confirmation of SARS-CoV-2 infection within 1 week prior to randomization

5. Randomization within 72 hr of hospital admission

6. Negative pregnancy test for reproductive age women

7. Patient or LAR able to provide informed consent

Exclusion criteria

1. Allergy or intolerance to losartan or other ARBs

2. Already taking ACE or ARB (within 1 month)

3. Hypotension at time of enrollment (SBP < 100 mm Hg)

4. Hyperkalemia (K >/= 5.0 at time of screening or history of hyperkalemia)

5. Severe renal dysfunction (estimated GFR < 30 ml/min at time of screening or history advanced renal disease)

6. Severe volume depletion or acute kidney injury (AKI) at time of enrollment

7. Known cirrhotic ascites

8. Known severe aortic or mitral valve stenosis

9. Known unstented renal artery stenosis

10. Co-administration with certain drugs due to CYP3A interactions if taken in < 24 hr

11. Severe hepatic insufficiency (LFTs > 5 times the upper limit of normal or known ESLD or cirrhosis)

12. Nausea/vomiting or aspiration risk precluding oral medications unless can be given by gastric tube

13. Pregnancy or breast feeding

14. Absence of dependable contraception in reproductive age women

15. Inability to obtain or declined informed consent