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

NCT04328012 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 1581969
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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).

Conditions

SARS-CoV-2 Infection

Keywords

COVID; COVID-19; coronavirus

Outcome Measures

Primary Outcomes (1)

• National Institute of Allergy and Infectious Diseases COVID-19 Ordinal Severity Scale (NCOSS)

  difference in NCOSS scores between the different treatment groups

  60 days

Secondary Outcomes (4)

• Hospital length of stay (LOS)

  60 days

• Intensive care unit level LOS

  60 days

• Mechanical ventilation

  60 days

• survival

  60 days

Study Arms (2)

Losartan

EXPERIMENTAL

losartan 25 mg po QD X 14 days

Drug: Losartan

Placebo

PLACEBO COMPARATOR

placebo QD X 14 days

Drug: Placebo

Interventions

Losartan DRUG

administered 14 days

Also known as: Cozaar

Losartan

Placebo DRUG

administered 14 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bassett Healthcare: lead
• Reid Health: collaborator
• Goshen Health System: collaborator

Study Sites (1)

Bassett Medical Center

Cooperstown, New York, 13326, United States

Location

Related Publications (1)

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Losartan

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Daniel Freilich, MD

  Bassett Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician - hospitalist

Model Details: randomized, double blind, placebo controlled clinical trial

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: April 6, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)