- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04328012
COVID MED Trial - Comparison Of Therapeutics for Hospitalized Patients Infected With COVID-19 (COVIDMED)
Comparison Of Therapeutics for Hospitalized Patients Infected With SARS-CoV-2 In a Pragmatic aDaptive randoMizED Clinical Trial During the COVID-19 Pandemic (COVID MED Trial)
Study Overview
Status
Conditions
Intervention / Treatment
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 RCT (COVID MED). Since then, dexamethasone has been shown to decrease mortality and remdesivir to possibly decrease hospital LOS in the RECOVERY and ACTT-II trials and others. The initial iteration of this protocol included 4 arms, hydroxychloroquine, lopinavir/ritonavir, losartan, and placebo based on suggestive efficacy and safety and widespread empiric use. The current iteration of COVID MED includes two arms, standard of care and losartan vs. standard of care and placebo.
Hydroxychloroquine was initially included in COVID MED based on suggestive in vitro, animal preclinical, and early RCT data, and widespread empiric use in hospitalized patients with COVID-19. Lopinavir/ritonavir, an antiretroviral medication, showed equivocal and possibly positive efficacy and safety in an early pandemic Chinese RCT published in NEJM. After public release and eventual publication of the negative results for hydroxychloroquine and then lopinavir/ritonavir initially from the RECOVERY trial and then others, enrollment in COVID MED in these two arms was halted and then discontinued permanently. Data from subjects enrolled in the hydroxychloroquine arm are being incorporated into a pooled analysis of RCTs by the Trial Innovation Network.
Losartan, an angiotensin II receptor blocker (ARB), has theoretical benefit as SARSCoV-2 appears to bind to lung tissue via Angiotensin-Converting Enzyme 2 (ACE-2) receptors which might be inhibited by ARBs; other potential benefits have been hypothesized as well. Since the initial iteration of this protocol, observational studies have shown that patients already taking ACEi/ARB medications do not have adverse outcome when these drugs are continued in hospitalized COVID-19 patients. These data have reinforced continuation of the losartan vs. placebo arms of this RCT which are ongoing.
This pragmatic adaptive trial continues to compare outcome in hospitalized COVID-19 patients treated with standard of care and losartan vs. standard of care and placebo.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
New York
-
Cooperstown, New York, United States, 13326
- Bassett Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Losartan
losartan 25 mg po QD X 14 days
|
administered 14 days
Other Names:
|
Placebo Comparator: Placebo
placebo QD X 14 days
|
administered 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
National Institute of Allergy and Infectious Diseases COVID-19 Ordinal Severity Scale (NCOSS)
Time Frame: 60 days
|
difference in NCOSS scores between the different treatment groups
|
60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital length of stay (LOS)
Time Frame: 60 days
|
difference in the total inpatient LOS between the three treatment groups
|
60 days
|
Intensive care unit level LOS
Time Frame: 60 days
|
difference in the total ICU level care LOS between the three treatment groups
|
60 days
|
Mechanical ventilation
Time Frame: 60 days
|
difference in length of use of mechanical ventilation between the three treatment groups
|
60 days
|
survival
Time Frame: 60 days
|
difference in all cause mortality between the four treatment groups
|
60 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Losartan
Other Study ID Numbers
- 1581969
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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