ACEi/ARB medications for hospitalized patients with COVID-19 – an individual patient data (IPD) based pooled analysis

Lead Investigator: Malathi Ram, Johns Hopkins University
Title of Proposal Research: ACEi/ARB medications for hospitalized patients with COVID-19 – an individual patient data (IPD) based pooled analysis
Vivli Data Request: 7520
Funding Source: Funding is via an administrative supplement mechanism of an existing NCATS award
Potential Conflicts of Interest: None

Summary of the Proposed Research:

ACEi/ARB medications might be beneficial in COVID-19 due to inhibition of viral entry into pneumocytes and alteration of local inflammatory and vasoconstriction/vasodilation balance. The current preclinical and clinical database, albeit limited, suggests equipoise or potential benefit for these medications in hospitalized patients with COVID-19.

This study is designed to confirm our hypothesis that treatment of hospitalized patients with SARS-CoV-2 infection with ACEi/ARB medications will improve clinical outcome in comparison with control treatments.

The necessity of this research is urgent given that over 650,000 Americans have died of COVID-19, daily deaths again surpassed 2,000 at the peak of the delta variant surge, and thus there is a continued need for effective therapeutics.

Currently, starting ACEi/ARB for COVID-19 de novo is not standard because supportive data is weak and evolving. If administration of simple and inexpensive ACEi/ARB medications in COVID-19 will decrease morbidity and mortality, the drugs can have an important effect on outcome of many thousands of hospitalized patients internationally.

This study will be the first IPD-meta analysis of ACEi/ARB medications in COVID-19 and only the third IPD-meta analysis in COVID-19 more broadly.

After down selection of targeted RCTs, finalization of data harmonization spreadsheets and deidentification/anonymization processes, completion of data sharing agreements, trialists will collate IPD data per supplied data harmonization spreadsheets, and upload the data to Vivil. Data will be transferred to JHU where analysis per our prespecified SAP will occur using Bayesian statistical methods. The study, including its SAP, were registered on PROSPERO (CRD42021254261).

Requested Studies:

An Open Label Phase 1 Trial of Losartan for Worsening Respiratory Illness in COVID-19
Data Contributor: University of Kansas Medical Center
Study ID: NCT04335123
Sponsor ID: STUDY00145514

Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection
Data Contributor: Sharp Healthcare
Study ID: NCT04340557

Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization
Data Contributor: University of Minnesota
Study ID: NCT04312009
Sponsor ID: SURG-2020-28675

COVIDMED-Comparison Of Therapeutics for Hospitalized Patients Infected With SARS-CoV
Data Contributor: Bassett Medical Center
Study ID: NCT04328012
Sponsor ID: NCT04328012