Status:
TERMINATED
COVID MED Trial - Comparison Of Therapeutics for Hospitalized Patients Infected With COVID-19
Lead Sponsor:
Bassett Healthcare
Collaborating Sponsors:
Reid Health
Goshen Health System
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Although a number of therapeutics have been utilized by clinicians to treat hospitalized patients with COVID-19, none were systematically evaluated in clinical trials at the time of the outset of this...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Hospitalized patient
- Age \>= 18 years
- Able to ingest oral medication or be administered medication via gastric tube or equivalent
- Laboratory confirmation of SARS-CoV-2 infection within 1 week prior to randomization
- Randomization within 72 hr of hospital admission
- Negative pregnancy test for reproductive age women
- Patient or LAR able to provide informed consent
- Exclusion criteria
- Allergy or intolerance to losartan or other ARBs
- Already taking ACE or ARB (within 1 month)
- Hypotension at time of enrollment (SBP \< 100 mm Hg)
- Hyperkalemia (K \>/= 5.0 at time of screening or history of hyperkalemia)
- Severe renal dysfunction (estimated GFR \< 30 ml/min at time of screening or history advanced renal disease)
- Severe volume depletion or acute kidney injury (AKI) at time of enrollment
- Known cirrhotic ascites
- Known severe aortic or mitral valve stenosis
- Known unstented renal artery stenosis
- Co-administration with certain drugs due to CYP3A interactions if taken in \< 24 hr
- Severe hepatic insufficiency (LFTs \> 5 times the upper limit of normal or known ESLD or cirrhosis)
- Nausea/vomiting or aspiration risk precluding oral medications unless can be given by gastric tube
- Pregnancy or breast feeding
- Absence of dependable contraception in reproductive age women
- Inability to obtain or declined informed consent
Exclusion
Key Trial Info
Start Date :
April 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04328012
Start Date
April 6 2020
End Date
December 1 2021
Last Update
March 24 2022
Active Locations (1)
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1
Bassett Medical Center
Cooperstown, New York, United States, 13326