Ramipril for the Treatment of COVID-19

NCT04366050 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: RAMIC Trial
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Composite of Mortality or Need for ICU Admission or Ventilator Use

  The major primary outcome to be evaluated is improving a composite outcome of mortality or need for ICU admission or ventilator use within a 14-day window.

  14 days

Study Arms (2)

Ramipril 2.5mg orally daily

EXPERIMENTAL

Total 2.5 mg Ramipril per day once a day orally for 14 days Intervention: Ramipril

Drug: Ramipril 2.5 MG Oral Capsule

Placebo

PLACEBO COMPARATOR

Placebo in the form of a capsule, taken orally for 14 days

Drug: Placebo oral capsule

Interventions

Ramipril 2.5 MG Oral Capsule DRUG

Include description or ramipril from protocol

Also known as: Ramipril

Ramipril 2.5mg orally daily

Placebo oral capsule DRUG

Placebo

Also known as: Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Willing and able to provide written informed consent prior to performing study procedures
• Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 5 days before randomization OR Clinical presentation consistent with COVID-19 infection (fever or cough or shortness of breath) with positive IgM serology
• Currently hospitalized or in an emergency department
• Peripheral capillary oxygen saturation (SpO2) ≥ 93% on room air at screening

You may not qualify if:

• Participation in any other clinical trial of an experimental treatment for COVID-19 (use of hydroxycholoroquine or compassionate use of choloroquine or azithromycin is allowed)
• Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited \< 24 hours prior to study drug/placebo dosing
• Requiring mechanical ventilation at screening
• Requiring ICU care at admission
• NSAID use within 12 hours of randomization or requiring continued NSAID use during this trial
• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN)
• Estimated GFR \< 40 mL/min
• History of serum creatinine ≥ 2 mg/dl in the previous 28 days
• Systolic BP \< 100 mm hg or diastolic BP \< 65 mm hg
• Hypersensitivity to ACEI
• History of angioedema
• Outpatient use of ACE inhibitor or Angiotensin II receptor blocker in the last 7 days
• History of renal artery stenosis
• Serum potassium ≥ 5.1 mEq/L
• Pregnancy or breastfeeding

Sponsors & Collaborators

• University of California, San Diego: lead
• Pfizer: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (2)

• Huang DQ, Ajmera V, Tomaszewski C, LaFree A, Bettencourt R, Thompson WK, Smith DM, Malhotra A, Mehta RL, Tolia V, Yin J, Insel PA, Leachman S, Jung J, Collier S, Richards L, Woods K, Amangurbanova M, Bhatt A, Zhang X, Penciu OM, Zarich S, Retta T, Harkins MS, Teixeira JP, Chinnock B, Utay NS, Lake JE, Loomba R. Ramipril for the Treatment of COVID-19: RAMIC, a Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Adv Ther. 2023 Nov;40(11):4805-4816. doi: 10.1007/s12325-023-02618-7. Epub 2023 Aug 24.

  PMID: 37615850 DERIVED

• Ajmera V, Thompson WK, Smith DM, Malhotra A, Mehta RL, Tolia V, Yin J, Sriram K, Insel PA, Collier S, Richards L, Loomba R. RAMIC: Design of a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of ramipril in patients with COVID-19. Contemp Clin Trials. 2021 Apr;103:106330. doi: 10.1016/j.cct.2021.106330. Epub 2021 Feb 22.

  PMID: 33631357 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ramipril

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Rohit Loomba, MD, MHSc
• Organization: UCSD

roloomba@ucsd.edu

858-246-2201

Study Officials

• Rohit Loomba

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: May 11, 2020
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Locations

US (1)