Aspirin vs Standard care/Placebo (RCT)

Hospitalized patients

On March 17, 2022 study Ghati, 2021 was excluded from the analysis since the paper is not anymore accessible on SSRN nor on published elsewhere. We have contacted authors for further details. FOREST PLOTS -2022-03-17

Studies description

Trial NCT04381936; ISRCTN50189673
Publication RECOVERY-ASA - Horby P, Lancet (2021) (published paper)
Dates: 2020-11-01 to 2021-03-21
Funding: Mixed (UK Research and Innovation; National Institute of Health Research ; the Wellcome Trust; Bill and Melinda Gates Foundation; Commonwealth and development Department.)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / UK, Indonesia, Nepal
Follow-up duration (days): 28
Inclusion criteria
  • Clinically suspected or laboratory confirmed SARS-CoV-2 infection
  • No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if they were to participate in the trial
Exclusion criteria
  • Children aged <18 years
  • Known hypersensitivity to aspirin, a recent history of major bleeding, or currently receiving aspirin or another antiplatelet treatment
  • Aspirin unavailable at the hospital at the time of enrolment
Interventions
Treatment
Aspirin
150 mg orally or by nasogastric tube or rectally once per day until discharge
Control
Standard care

Participants
Randomized
participants :
Aspirin=7351
Standard care=7541
Characteristics of participants
N= 14892
Mean age : NR
9201 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=4190 Critical: n=730
Primary outcome
In the register
All-cause mortality [ Time Frame: Within 28 days after randomisation ]
In the report
28-day mortality
Documents
avalaible

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the pre-print, the trial registries, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. There were no substantive differences between the pre-print article and the registry, protocol or statistical analysis plan on procedures, interventions or outcomes. The RECOVERY trial is an investigator-initiated, individually randomized, controlled, open-label, adaptive platform trial to evaluate the effects of potential treatments in patients hospitalized with COVID-19. The trial was conducted at 177 National Health Service (NHS) hospital organizations in the United Kingdom, two hospitals in Indonesia and two hospitals in Nepal. The Aspirin arm was added to the protocol and registry in November. All outcomes from the registry are reported in the paper. Pre-specified analyses of the primary outcome were performed in five subgroups defined by characteristics at randomization: age, sex, level of respiratory support, days since symptom onset, and use of corticosteroids. The study was updated on December 7th, 2021 with data from the published article.