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Aspirin as a Treatment for ARDS: A Randomized, Placebo-Controlled Clinical Trial.
Toner, Philip; Boyle, Andrew J; McNamee, James J; Callaghan, Kathryn; Nutt, Christopher; Johnston, Paul; Trinder, John; McFarland, Margaret; Verghis, Rejina; McAuley, Daniel F; O'Kane, Cecilia M.
  • Toner P; Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland; Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland. Electronic address: philip.toner@belfasttrsut.
  • Boyle AJ; Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland; Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland.
  • McNamee JJ; Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland.
  • Callaghan K; Altnagelvin Area Hospital, Londonderry, Northern Ireland.
  • Nutt C; Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland.
  • Johnston P; Antrim Area Hospital, Antrim, Northern Ireland.
  • Trinder J; Ulster Hospital, Dundonald, Belfast, Northern Ireland.
  • McFarland M; Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland.
  • Verghis R; Northern Ireland Clinical Trial Unit, Royal Hospitals, Belfast, Northern Ireland.
  • McAuley DF; Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland; Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland.
  • O'Kane CM; Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland.
Chest ; 161(5): 1275-1284, 2022 05.
Article in English | MEDLINE | ID: covidwho-1828073
ABSTRACT

BACKGROUND:

There is no pharmacologic treatment for ARDS. Platelets play an important role in the pathophysiology of ARDS. Preclinical, observational, and clinically relevant models of ARDS indicate aspirin as a potential therapeutic option. RESEARCH QUESTION Is enteral aspirin (75 mg, once daily) safe and effective in improving surrogate outcomes in adult patients with ARDS? STUDY DESIGN AND

METHODS:

This randomized, double-blind (patient and investigator), allocation-concealed, placebo-controlled phase 2 trial was conducted in five UK ICUs. Patients fulfilling the Berlin definition of ARDS were randomly assigned at a 11 ratio to receive enteral aspirin (75 mg) or placebo, for a maximum of 14 days, using a computer-generated randomization schedule, with variable block size, stratified by vasopressor requirement. The primary end point was oxygenation index (OI) on day 7. Secondary outcomes included safety parameters and other respiratory physiological markers. Analyses were by intention to treat.

RESULTS:

The trial was stopped early, due to slow recruitment, after 49 of a planned 60 patients were recruited. Twenty-four patients were allocated to aspirin and 25 to placebo. There was no significant difference in day 7 OI [aspirin group unadjusted mean, 54.4 (SD 26.8); placebo group 42.4 (SD 25); mean difference, 12.0; 95% CI, -6.1 to 30.1; P = .19]. Aspirin did not significantly impact the secondary outcomes. There was no difference in the number of adverse events between the groups (13 in each; OR, 1.04; 95% CI, 0.56-1.94; P = .56).

INTERPRETATION:

Aspirin was well tolerated but did not improve OI or other physiological outcomes; a larger trial is not feasible in its current design. TRIAL REGISTRATION ClinicalTrials.gov; No. NCT02326350; URL www. CLINICALTRIALS gov.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Distress Syndrome / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Humans Language: English Journal: Chest Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Distress Syndrome / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Humans Language: English Journal: Chest Year: 2022 Document Type: Article