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.
Authors
McEvoy, Natalie LClarke, Jennifer L
Mc Elvaney, Oliver J
Mc Elvaney, Oisin F
Boland, Fiona
Hyland, Deirdre
Geoghegan, Pierce
Donnelly, Karen
Friel, Oisin
Cullen, Ailbhe
Collins, Ann M
Fraughen, Daniel
Martin-Loeches, Ignacio
Hennessy, Martina
Laffey, John G
Mc Elvaney, Noel G
Curley, Gerard F
Issue Date
2021-04-19Keywords
ardsAcute respiratory distress syndrome
Covid-19
SARS-CoV-2
alpha-1 antitrypsin
protocol
randomised controlled trial
Metadata
Show full item recordJournal
TrialsDOI
10.1186/s13063-021-05254-0PubMed ID
33874981Abstract
The study will be conducted in Intensive Care Units in hospitals across Ireland. Patients with a laboratory-confirmed diagnosis of SARS-CoV-2-infection, moderate to severe ARDS (meeting Berlin criteria for a diagnosis of ARDS with a PaO2/FiO2 ratio <200 mmHg), >18 years of age and requiring invasive or non-invasive mechanical ventilation. All individuals meeting any of the following exclusion criteria at baseline or during screening will be excluded from study participation: more than 96 hours has elapsed from onset of ARDS; age < 18 years; known to be pregnant or breastfeeding; participation in a clinical trial of an investigational medicinal product (other than antibiotics or antivirals) within 30 days; major trauma in the prior 5 days; presence of any active malignancy (other than nonmelanoma skin cancer) which required treatment within the last year; WHO Class III or IV pulmonary hypertension; pulmonary embolism prior to hospital admission within past 3 months; currently receiving extracorporeal life support (ECLS); chronic kidney disease receiving dialysis; severe chronic liver disease with Child-Pugh score > 12; DNAR (Do Not Attempt Resuscitation) order in place; treatment withdrawal imminent within 24 hours; Prisoners; non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; IgA deficiency.Item Type
OtherLanguage
enEISSN
1745-6215ae974a485f413a2113503eed53cd6c53
10.1186/s13063-021-05254-0
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