UK site teams

remap-cap and recovery collaboration plan

Coordination of ASPECT and RECOVERY trials

ASPECT and RECOVERY are large-scale, open-label, randomised trials evaluating treatments for patients admitted to hospital with community-acquired pneumonia.

ASPECT is assessing whether aspirin reduces the risk of major cardiovascular events, and RECOVERY is assessing whether dexamethasone improves 28-day survival. Both are designed to have broad eligibility criteria and streamlined procedures to minimise work for clinical and research teams. Many patients will be eligible for only one of the trials (e.g. if one trial treatment is indicated for another reason), but many patients will be eligible for inclusion in both trials.

ASPECT and RECOVERY have agreed that:

• Both trials can operate in the same locations if there is capacity to do so.
• There is no conflict between the trial treatments or procedures, so if a patient meets the eligibility criteria for both trials they can be recruited into both.
• The decision whether or not to use gastroprotection in co-enrolled patients is left to the patient’s clinical team in line with their usual practice, taking into account other risk factors the patient may have for gastrointestinal bleeding (both aspirin and corticosteroids moderately increase the risk of GI bleeding¹).
• ASPECT and RECOVERY will work together to share information on participating sites, interventions, and co-enrolments.

¹ In RECOVERY, aspirin increased the risk of GI bleeding from 0.4% to 0.8% in patients hospitalised with COVID-19 (pubmed.ncbi.nlm.nih.gov/34800427). In a meta-analysis of critically ill patients, corticosteroids increased the risk of GI bleeding from 1.8% to 2.3% (pubmed.ncbi.nlm.nih.gov/31501997).