CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 160 enrolled
Drug / intervention
Ramipril 2.5 MG Oral Capsule +1 moredrug
Likely dose
Ramipril 2.5 mg oral capsuleAI-extracted
Key inclusion· 4
  • Age ≥18 years
  • SARS-CoV-2 infection confirmed by PCR within 5 days before randomization OR clinical presentation consistent with COVID-19 with positive IgM serology
  • Currently hospitalized or in emergency department
  • Peripheral oxygen saturation (SpO2) ≥93% on room air at screening
Key exclusion· 14
  • Requiring mechanical ventilation at screening
  • Requiring ICU care at admission
  • ALT or AST >5× upper limit of normal
  • Estimated GFR <40 mL/min

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04366050
NCT04366050Phase 2Completed

A Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy of Ramipril to Prevent ICU Admission, Need for Mechanical Ventilation or Death in Persons With COVID-19

University of California, San Diego·interventional·Posted Apr 28, 2020·Updated Sep 28, 2023

In Brief

A Phase 2 clinical trial evaluating Ramipril 2.5 MG Oral Capsule and Placebo oral capsule for COVID-19. Completed, enrolled 160 participants across 1 site.

Detailed Summary

In this study we propose to treat 560 patients with ramipril or placebo for 14 days. After an initial evaluation for COVID-19 status, medical history, and symptom assessment, patients will receive either 2.5 mg/day of ramipril or placebo. Patients' symptoms and study endpoints will be monitored at regular intervals. After 14 days, patients will undergo a laboratory assessment and an end-of-treatment follow-up visit at day 28. The primary endpoints of successful therapy will be improved survival, reductions in ICU admissions, and/or reductions in use of mechanical ventilator support.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 28, 2020
Enrollment StartMay 11, 2020
Primary CompletionMay 12, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.2 years ago

Interventions

Ramipril 2.5 MG Oral Capsuledrug

Include description or ramipril from protocol

Placebo oral capsuledrug

Placebo