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10.1016/j.cct.2021.106330

http://scihub22266oqcxt.onion/10.1016/j.cct.2021.106330
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33631357!7899027!33631357
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suck abstract from ncbi


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pmid33631357      Contemp+Clin+Trials 2021 ; 103 (ä): 106330
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  • RAMIC: Design of a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of ramipril in patients with COVID-19 #MMPMID33631357
  • Ajmera V; Thompson WK; Smith DM; Malhotra A; Mehta RL; Tolia V; Yin J; Sriram K; Insel PA; Collier S; Richards L; Loomba R
  • Contemp Clin Trials 2021[Apr]; 103 (ä): 106330 PMID33631357show ga
  • BACKGROUND AND AIMS: Retrospective studies have shown that angiotensin-converting-enzyme (ACE) inhibitors are associated with a reduced risk of complications and mortality in persons with novel coronavirus disease 2019 (COVID-19). Thus, we aimed to examine the efficacy of ramipril, an ACE-inhibitor, in preventing ICU admission, mechanical ventilation and/or mortality while also minimizing the risk of transmission and use of personal protective equipment (PPE). METHODS: RAMIC is a multicenter, randomized, double-blind, allocation-concealed, placebo-controlled trial comparing the efficacy of treatment with ramipril 2.5 mg orally daily compared to placebo for 14 days. The study population includes adult patients with COVID-19 who were admitted to a hospital or assessed in an emergency department or ambulatory clinic. Key exclusion criteria include ICU admission or need for mechanical ventilation at screening, use of an ACE inhibitor or angiotensin-receptor-II blocker within 7 days, glomerular filtration rate < 40 mL/min or a systolic blood pressure (BP) < 100 mmHg or diastolic BP < 65 mmHg. Patients are randomized 2:1 to receive ramipril (2.5 mg) or placebo daily. Informed consent and study visits occur virtually to minimize the risk of SARS-CoV-2 transmission and preserve PPE. The primary composite endpoint of ICU admission, invasive mechanical ventilation and death are adjudicated virtually. CONCLUSIONS: RAMIC is designed to assess the efficacy of treatment with ramipril for 14 days to decrease ICU admission, mechanical ventilator use and mortality in patients with COVID-19 and leverages virtual study visits and endpoint adjudication to mitigate risk of infection and to preserve PPE (ClinicalTrials.gov, NCT04366050).
  • |*COVID-19/complications/mortality/therapy/transmission[MESH]
  • |*Ramipril/administration & dosage/adverse effects[MESH]
  • |Adult[MESH]
  • |Angiotensin-Converting Enzyme Inhibitors/administration & dosage/adverse effects[MESH]
  • |Biomarkers/analysis[MESH]
  • |Critical Care/statistics & numerical data[MESH]
  • |Disease Transmission, Infectious/prevention & control[MESH]
  • |Double-Blind Method[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Male[MESH]
  • |Mortality[MESH]
  • |Randomized Controlled Trials as Topic[MESH]
  • |Respiration, Artificial/statistics & numerical data[MESH]
  • |SARS-CoV-2[MESH]


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