Ramipril for the Treatment of COVID-19: RAMIC, a Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Humans Female Male COVID-19 Ramipril / therapeutic use SARS-CoV-2 Retrospective Studies Prospective Studies Angiotensin-Converting Enzyme Inhibitors / therapeutic use Double-Blind Method Treatment Outcome
COVID-19 Coronavirus Ramipril Therapy

Journal

Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864

Informations de publication

Date de publication:
11 2023
Historique:
received: 23 05 2023
accepted: 14 07 2023
pmc-release: 01 05 2024
medline: 27 11 2023
pubmed: 24 8 2023
entrez: 24 8 2023
Statut: ppublish

Résumé

Retrospective studies report that angiotensin-converting enzyme inhibitors (ACEIs) may reduce the severity of COVID-19, but prospective data on de novo treatment with ACEIs are limited. The RAMIC trial was a randomized, multicenter, placebo-controlled, double-blind, allocation-concealed clinical trial to examine the efficacy of de novo ramipril versus placebo for the treatment of COVID-19. Eligible participants were aged 18 years and older with a confirmed diagnosis of SARS-CoV-2 infection, recruited from urgent care clinics, emergency departments, and hospital inpatient wards at eight sites in the USA. Participants were randomly assigned to daily ramipril 2.5 mg or placebo orally in a 2:1 ratio, using permuted block randomization. Analyses were conducted on an intention-to-treat basis. The primary outcome was a composite of mortality, intensive care unit (ICU) admission, or invasive mechanical ventilation by day 14. Between 27 May 2020 and 19 April 2021, a total of 114 participants (51% female) were randomized to ramipril (n = 79) or placebo (n = 35). The overall mean (± SD) age and BMI were 45 (± 15) years and 33 (± 8) kg/m De novo ramipril was not different compared with placebo in improving or worsening clinical outcomes from COVID-19 but appeared safe in non-critically ill patients with COVID-19. Clinicaltrials.gov NCT04366050.

Identifiants

DOI: 10.1007/s12325-023-02618-7 PMID: 37615850 PMC: PMC10709987
pubmed: 37615850
doi: 10.1007/s12325-023-02618-7
pii: 10.1007/s12325-023-02618-7
pmc: PMC10709987
mid: NIHMS1928648
doi:

Substances chimiques

Ramipril L35JN3I7SJ
Angiotensin-Converting Enzyme Inhibitors 0

Banques de données

ClinicalTrials.gov
['NCT04366050']

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article Research Support, N.I.H., Extramural

Langues

eng

Pagination

4805-4816

Subventions

Organisme : NIDDK NIH HHS
ID : U01 DK130190
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL157985
Pays : United States
Organisme : NHLBI NIH HHS
ID : T32 HL134632
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001442
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL166485
Pays : United States
Organisme : NIDDK NIH HHS
ID : R01 DK124318
Pays : United States
Organisme : NIA NIH HHS
ID : R01 AG063925
Pays : United States
Organisme : NIDDK NIH HHS
ID : U01 DK061734
Pays : United States
Organisme : NHLBI NIH HHS
ID : P01 HL147835
Pays : United States
Organisme : NIDDK NIH HHS
ID : R01 DK121378
Pays : United States
Organisme : NIDDK NIH HHS
ID : R01 DK106419
Pays : United States
Organisme : NIEHS NIH HHS
ID : P42 ES010337
Pays : United States
Organisme : NHLBI NIH HHS
ID : T32 HL166127
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001449
Pays : United States
Organisme : NIDDK NIH HHS
ID : P30 DK120515
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL154926
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL148436
Pays : United States

Informations de copyright

© 2023. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.

Références

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Auteurs

Daniel Q Huang (DQ)

NAFLD Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA.
Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore, Singapore.

Veeral Ajmera (V)

NAFLD Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA.
Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, CA, USA.

Christian Tomaszewski (C)

Department of Emergency Medicine, University of California, San Diego and the El Centro Regional Medical Center, San Diego, CA, USA.

Andrew LaFree (A)

Department of Emergency Medicine, University of California, San Diego and the El Centro Regional Medical Center, San Diego, CA, USA.

Ricki Bettencourt (R)

NAFLD Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA.

Wesley K Thompson (WK)

Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA, USA.

Davey M Smith (DM)

Division of Infectious Diseases and Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.
Veteran Affairs Medical Center, San Diego, CA, USA.

Atul Malhotra (A)

Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, University of California San Diego, La Jolla, CA, USA.

Ravindra L Mehta (RL)

Division of Nephrology-Hypertension, Department of Medicine, University of California San Diego, La Jolla, CA, USA.

Vaishal Tolia (V)

Department of Emergency Medicine, University of California San Diego, La Jolla, CA, USA.

Jeffrey Yin (J)

Department of Pharmacy, University of California San Diego, La Jolla, CA, USA.

Paul A Insel (PA)

Department of Pharmacology, University of California San Diego, La Jolla, CA, USA.
Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, CA, USA.

Stone Leachman (S)

NAFLD Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA.

Jinho Jung (J)

NAFLD Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA.

Summer Collier (S)

Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, CA, USA.

Lisa Richards (L)

NAFLD Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA.

Kristin Woods (K)

Clinical & Translational Research Institute, University of California, San Diego, La Jolla, CA, USA.

Maral Amangurbanova (M)

NAFLD Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA.

Archana Bhatt (A)

Clinical & Translational Research Institute, University of California, San Diego, La Jolla, CA, USA.

Xinlian Zhang (X)

Division of Biostatistics and Bioinformatics, Herbert Wertheim School of Public Health, University of California San Diego, San Diego, CA, USA.

Oana M Penciu (OM)

Beverly Hospital, Montebello, CA, USA.

Stuart Zarich (S)

Section of Cardiovascular Medicine, Yale New Haven Health Bridgeport Hospital, Bridgeport, CT, USA.

Tamrat Retta (T)

Department of Internal Medicine, Howard University, Washington, DC, USA.

Michelle S Harkins (MS)

Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.

J Pedro Teixeira (JP)

Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.

Brian Chinnock (B)

Department of Emergency Medicine, University of California San Francisco-Fresno Medical Education Program, Fresno, CA, USA.

Netanya S Utay (NS)

Division of Infectious Diseases and Geographic Medicine, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.

Jordan E Lake (JE)

Division of Infectious Diseases, Department of Internal Medicine, McGovern Medical School, University of Texas Health Science Center, Houston, TX, USA.

Rohit Loomba (R)

NAFLD Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA. roloomba@ucsd.edu.
Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, CA, USA. roloomba@ucsd.edu.
Division of Epidemiology, Department of Family Medicine and Public Health, University of California at San Diego, San Diego, CA, USA. roloomba@ucsd.edu.

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