ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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
- 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
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| 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 |
| ||||
| Study Arms ICMJE |
| ||||
| Publications * | Not Provided | ||||
* 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 | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| 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 |
| ||||
| 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 | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||