Ramipril for the Treatment of COVID-19 (RAMIC)

• ClinicalTrials.gov Identifier: NCT04366050
• Recruitment Status: Recruiting
• First Posted: April 28, 2020
• Last Update Posted: January 20, 2021
• Sponsor: University of California, San Diego
• Collaborator: Pfizer
• Information provided by (Responsible Party): Rohit Loomba, University of California, San Diego

Tracking Information

• First Submitted Date: April 24, 2020
• First Posted Date: April 28, 2020
• Last Update Posted Date: January 20, 2021
• Actual Study Start Date: May 11, 2020
• Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 24, 2020)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ramipril for the Treatment of COVID-19
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: COVID-19

Intervention

• Drug: Ramipril 2.5 MG Oral Capsule
  Include description or ramipril from protocol
  Other Name: Ramipril
• Drug: Placebo oral capsule
  Placebo
  Other Name: Placebo

Study Arms

• Experimental: Ramipril 2.5mg orally daily

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

  Intervention: Ramipril

  Intervention: Drug: Ramipril 2.5 MG Oral Capsule
• Placebo Comparator: Placebo
  Placebo in the form of a capsule, taken orally for 14 days
  Intervention: Drug: Placebo oral capsule

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 24, 2020): 560
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2021
• Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Len Lazaro; 858-822-3708; llazaro@health.ucsd.edu

Contact: Archana Bhatt; 858-822-2661; abhatt@health.ucsd.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04366050
• Other Study ID Numbers: RAMIC Trial
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Rohit Loomba, University of California, San Diego
• Study Sponsor: University of California, San Diego
• Collaborators: Pfizer
• Investigators: Not Provided
• PRS Account: University of California, San Diego
• Verification Date: January 2021