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Ramipril for the Treatment of COVID-19 (RAMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366050
Recruitment Status : Not yet recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rohit Loomba, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Ramipril 2.5 MG Oral Capsule Drug: Placebo oral capsule Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril

Arm Intervention/treatment
Experimental: Ramipril 2.5mg orally daily

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

Intervention: Ramipril

Drug: Ramipril 2.5 MG Oral Capsule
Include description or ramipril from protocol
Other Name: Ramipril

Placebo Comparator: Placebo
Placebo in the form of a capsule, taken orally for 14 days
Drug: Placebo oral capsule
Placebo
Other Name: Placebo




Primary Outcome Measures :
  1. Composite of mortality or need for ICU admission or ventilator use [ Time Frame: 14 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Use of aliskiren, amifostine, lithium, sacubitril within 7 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366050


Contacts
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Contact: Len Lazaro 858-822-2661 llazaro@health.ucsd.edu
Contact: Archana Bhatt 858-822-2661 abhatt@health.ucsd.edu

Sponsors and Collaborators
University of California, San Diego
Pfizer
Additional Information:
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Responsible Party: Rohit Loomba, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04366050    
Other Study ID Numbers: RAMIC Trial
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents