2.1 Study design and participants
myocardial infarction, SARS-CoV-2 infection, angina, fever, shock, sub-valvular aortic stenosis, cough, hypoxemia
MYOCARDIAL INFARCTION, SARS-COV-2 INFECTION, SHOCK, ASYMPTOMATIC SARS-COV-2 INFECTION, BILATERAL PULMONARY INFILTRATES, GASTRIC OR DUODENAL ULCER, BLEEDING DISORDER, S; HEMOGLOBIN, G6PD DEFICIENCY
This study was a two-arm, open-label, single site randomized controlled trial (RCT) conducted in an urban academic medical center in New Jersey, United States of America. FDA-approval was obtained for exemption from Investigational New Drug Application (IND) to conduct a clinical investigation with the drug Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg). A placebo group was not included in the current study given the ethical concerns of the authors for not providing treatment for COVID-19 hospitalized patients especially when FDA approved drugs existed at the time of study [All the patients included in this trial were admitted to the hospital during the 2Adult patients (aged ≥18 years) who were hospitalized for suspected symptomatic SARS-CoV-2 infection with a high clinical suspicion for COVID-19 (fever and cough for ≤ 7 days, bilateral pulmonary infiltrates on imaging or new hypoxemia with spO2 ≤94% on room air or no alternative explanation for respiratory symptoms) were eligible for inclusion in the study. Patients required a positive laboratory test for SARS-CoV-2 infection within 3 days of hospitalization. Patients were then excluded based on the following criteria: pregnancy; history of G6PD deficiency; antiplatelet agents including inhibitor of P2Y12 ADP platelet receptors, phosphodiesterase inhibitors, and glycoprotein IIB/IIIA inhibitors; therapeutic anticoagulation with coumadin, unfractionated or low molecular weight heparin, and direct oral anticoagulants; vasodilatory shock; known ongoing angina, recent myocardial infarction and sub-valvular aortic stenosis; active gastric or duodenal ulcer or any bleeding disorder or creatinine clearance < 10; hemoglobin <9 mg/dL, platelet count of <30,000 /mm