Covid-19
Conditions
Keywords
Adult Respiratory Distress Syndrome, Pneumonia, Myocardial infarction
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.
Interventions
DRUGAspirin
Aspirin 150mg
DRUGLosartan
Losartan 100mg
DRUGSimvastatin
Simvastatin 80mg
Sponsors
London School of Hygiene and Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 x 2 x 2
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | up to 28 days of randomisation | Cause of death will be described |
Secondary
| Measure | Time frame |
|---|---|
| Congestive cardiac failure | up to 28 days of randomisation |
| Severe cardiac arrythmia | up to 28 days of randomisation |
| Myocarditis | up to 28 days of randomisation |
| Respiratory failure including ARDS | up to 28 days of randomisation |
| Viral pneumonitis | up to 28 days of randomisation |
| Myocardial infarction | up to 28 days of randomisation |
| Sepsis | up to 28 days of randomisation |
| Stroke | up to 28 days of randomisation |
| Gastrointestinal bleeding | up to 28 days of randomisation |
| Receipt of non invasive or mechanical ventilation | up to 28 days of randomisation |
| Ability to self care at hospital discharge | up to 28 days of randomisation |
| Acute renal failure | up to 28 days of randomisation |
Countries
Nigeria, Pakistan
Outcome results
None listed