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Ramipril for the Treatment of COVID-19 (RAMIC)

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

Tracking Information
First Submitted Date  ICMJE April 24, 2020
First Posted Date  ICMJE April 28, 2020
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE May 11, 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ramipril for the Treatment of COVID-19
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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  ICMJE
  • 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 * 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 Feb 22;103:106330. doi: 10.1016/j.cct.2021.106330. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2020)
560
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Len Lazaro 858-822-3708 llazaro@health.ucsd.edu
Contact: Archana Bhatt 858-822-2661 abhatt@health.ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04366050
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Rohit Loomba, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account University of California, San Diego
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP