Official Title
Aspirin, Losartan and Simvastatin in Hospitalised COVID-19 Patients: a Multinational Randomised Open-label Factorial Trial
Brief Summary

The CRASH-19 trial is a multinational, open-label, factorial, randomised trial in adults hospitalised with suspected or confirmed acute COVID-19 infection.

Detailed Description

We will evaluate the effect of aspirin (150mg once daily), losartan (100mg once daily), and

simvastatin (80mg once daily) in patients with COVID-19 infection.



Eligible patients will be randomly allocated to one of eight study arms (aspirin only;

losartan only; simvastatin only; aspirin and losartan; aspirin and simvastatin; losartan and

simvastatin; aspirin, losartan and simvastatin; standard care only). Trial treatments are

given in addition to the usual standard of care at the study hospital.



Treatment will be started as soon as possible after randomisation and will continue until

death, discharge or 28 days after randomisation, whichever occurs first.

Withdrawn
COVID-19

Drug: Aspirin
Aspirin 150mg
Aspirin
Aspirin and Losartan
Aspirin and Simvastatin
Aspirin, Losartan and Simvastatin

Drug: Losartan
Losartan 100mg
Aspirin and Losartan
Aspirin, Losartan and Simvastatin
Losartan
Losartan and Simvastatin

Drug: Simvastatin
Simvastatin 80mg
Aspirin and Simvastatin
Aspirin, Losartan and Simvastatin
Losartan and Simvastatin
Simvastatin

Eligibility Criteria

Inclusion Criteria: - Adults age 40 years and older - with suspected or confirmed acute COVID-19 infection. Acute COVID-19 infection is suspected in the presence of a fever and at least one symptom of respiratory disease e.g. cough, difficulty breathing, signs of hypoxia. The clinician may suspect COVID-19 infection if i) the patient lives in or has recently travelled to an area with COVID-19 transmission; ii) the patient had recent contact with a confirmed or probable COVID-19 case, or iii) no alternative diagnosis fully explains the clinical presentation - requiring hospitalisation

Exclusion Criteria: - Women known to be pregnant - Patients hospitalised without symptoms of acute COVID-19 infection should not be recruited even if they test positive for COVID-19 - Patients already receiving mechanical ventilation - Patients with a definite indication or contraindication for any of the trial treatments. - Patients who are very severely frail (completely dependent and approaching end of life who typically they could not recover even from a mild illness) or terminally ill should not be recruited.

Eligibility Gender
All
Eligibility Age
Minimum: 40 Years
Countries
Nigeria
Pakistan

Haleema Shakur-Still
Study Chair
London School of Hygiene and Tropical Medicine

~

Ian Roberts
Study Chair
London School of Hygiene and Tropical Medicine

London School of Hygiene and Tropical Medicine
NCT Number
Keywords
Adult respiratory distress syndrome
Pneumonia
Myocardial infarction
MeSH Terms
Aspirin
Losartan
Simvastatin