The efficacy of N-Acetylcysteine in severe COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial

In this study, we evaluate the efficacy of N-Acetylcysteine in patients with severe COVID-19.Trial designThis is a prospective, randomized, single-blinded, phase 3 controlled clinical trial with two arms (ratio 1:1) parallel-group design of 40 patients, using the placebo in the control group.ParticipantsAll severe COVID-19 patients with at least one of the following five conditions: (respiration rate> 30 per minute), hypoxemia (O2 ≤ saturation, arterial oxygen partial pressure ratio<300), pulmonary infiltration (> 50% of lung area during 24 48 h), Lactate dehydrogenase (LDH)> 245 U / l, Progressive lymphopenia, and admitted to the intensive care unit of Shahid Mohammadi Hospital in Bandar Abbas and have positive PCR test results for SARS-Cov-2 and sign the written consent of the study will be included. Patients will be excluded from the study if they have a history of hypersensitivity to N-Acetylcysteine, pregnancy, or refuse to participate in the study.Intervention and comparatorAfter randomization, participants in the intervention group receive standard of care (SOC) according to the National Committee of COVID-19 plus N-acetylcysteine (EXI-NACE 200mg/mL, in 10mL ampules of saline for parenteral injection (EXIR pharmaceutical company)) at a dose of 300 mg/kg equivalent to 20 gr as a slow single intravenous injection on the first day of hospitalization. In the control group patients receive SOC and placebo ( Sterile water for injection as the same dose). The pl...
Source: Trials - Category: Research Source Type: clinical trials