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NCT04366050: RAMIC

Ramipril for the Treatment of COVID-19

Completed Phase 2 Results posted Last updated 28 September 2023
What this trial tests

Phase 2 trial testing Ramipril 2.5 MG Oral Capsule in COVID-19 in 160 participants. Completed in 12 May 2021.

Timeline
11 May 2020
Primary endpoint
12 May 2021
12 May 2021

Quick facts

Lead sponsorUniversity of California, San Diego
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment160
Start date11 May 2020
Primary completion12 May 2021
Estimated completion12 May 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Diego

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Composite of Mortality or Need for ICU Admission or Ventilator Use Primary · 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.

GroupValue95% CI
Ramipril 2.5mg Orally Daily2
Placebo0

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 Days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ramipril 2.5mg Orally Daily
Serious: 2/79 (3%)
Deaths: 1/79
Placebo
Serious: 0/35 (0%)
Deaths: 0/35

Serious adverse events (2 terms)

ReactionSystemRamipril 2.5mg Orally DailyPlacebo
Cardiopulmonary FailureCardiac disorders
HypertensionCardiac disorders
Other adverse events (17 terms — click to expand)

ReactionSystemRamipril 2.5mg Orally DailyPlacebo
LightheadednessGeneral disorders
Head or Body PainGeneral disorders
Cough/Shortness of Breath/Pulmonary embolusRespiratory, thoracic and mediastinal disorders
Cardiovascular IssuesCardiac disorders
Diarrhea/VomitingGastrointestinal disorders
Elevated Lab MarkersGeneral disorders
Drenching SweatsGeneral disorders
Loss of SmellGeneral disorders
AcneSkin and subcutaneous tissue disorders
Rectal HemorrhageGeneral disorders
Ear InfectionEar and labyrinth disorders
Steroid induced DiabetesEndocrine disorders
Worsening GERDGastrointestinal disorders
Urinary Tract InfectionRenal and urinary disorders
PancreatitisEndocrine disorders
Throat SwellingRespiratory, thoracic and mediastinal disorders
JitteryGeneral disorders

Most-reported serious reactions: Cardiopulmonary Failure, Hypertension.

Data from ClinicalTrials.gov NCT04366050 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
    Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
  2. Endothelial dysfunction in COVID-19: Current findings and therapeutic implications.
    Nägele MP, Haubner B, Tanner FC, Ruschitzka F, et al · · 2020 · cited 205× · PMID 33161318 · DOI 10.1016/j.atherosclerosis.2020.10.014
  3. ACE2 imbalance as a key player for the poor outcomes in COVID-19 patients with age-related comorbidities - Role of gut microbiota dysbiosis.
    Viana SD, Nunes S, Reis F. · · 2020 · cited 122× · PMID 32683039 · DOI 10.1016/j.arr.2020.101123
  4. Cardiac involvement in the long-term implications of COVID-19.
    Satterfield BA, Bhatt DL, Gersh BJ. · · 2022 · cited 101× · PMID 34686843 · DOI 10.1038/s41569-021-00631-3
  5. DPP4 and ACE2 in Diabetes and COVID-19: Therapeutic Targets for Cardiovascular Complications?
    Valencia I, Peiró C, Lorenzo Ó, Sánchez-Ferrer CF, et al · · 2020 · cited 79× · PMID 32848769 · DOI 10.3389/fphar.2020.01161
  6. Inflammation and thrombosis in COVID-19 pathophysiology: proteinase-activated and purinergic receptors as drivers and candidate therapeutic targets.
    Sriram K, Insel PA. · · 2021 · cited 70× · PMID 33124941 · DOI 10.1152/physrev.00035.2020
  7. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
    Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
  8. Potential Therapeutic Options for COVID-19: Current Status, Challenges, and Future Perspectives.
    Sarkar C, Mondal M, Torequl Islam M, Martorell M, et al · · 2020 · cited 64× · PMID 33041814 · DOI 10.3389/fphar.2020.572870

Verify or expand the search:

Other recruiting trials for COVID-19

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04366050.

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