A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial.
Natalie L McEvoyJennifer L ClarkeOliver J Mc ElvaneyOisin F Mc ElvaneyFiona BolandDeirdre HylandPierce GeogheganKaren DonnellyOisin FrielAilbhe CullenAnn M CollinsDaniel FraughenIgnacio Martin-LoechesMartina HennessyJohn G LaffeyNoel G Mc ElvaneyGerard F CurleyPublished in: Trials (2021)
The full protocol (version 3.0 23.11.2020) is attached as an additional file accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).
Keyphrases
- placebo controlled
- double blind
- study protocol
- acute respiratory distress syndrome
- randomized controlled trial
- sars cov
- clinical trial
- extracorporeal membrane oxygenation
- phase ii
- mechanical ventilation
- phase iii
- phase ii study
- open label
- clinical practice
- high glucose
- high dose
- low dose
- intensive care unit
- coronavirus disease
- radiation therapy
- rectal cancer