Coronavirus Response - Active Support for Hospitalised Covid-19 Patients
- Registration Number
- NCT04343001
- Lead Sponsor
- London School of Hygiene and Tropical Medicine
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Simvastatin Simvastatin Simvastatin 80mg once daily Aspirin and Losartan Losartan Aspirin 150mg once daily and Losartan 100mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period. Aspirin and Losartan Aspirin Aspirin 150mg once daily and Losartan 100mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period. Aspirin and Simvastatin Simvastatin Aspirin 150mg once daily and Simvastatin 80mg once daily Losartan and Simvastatin Simvastatin Losartan 100mg once daily and Simvastatin 80mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period. Losartan and Simvastatin Losartan Losartan 100mg once daily and Simvastatin 80mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period. Aspirin Aspirin Aspirin 150mg once daily Losartan Losartan Losartan 100mg once daily. Dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period. Aspirin and Simvastatin Aspirin Aspirin 150mg once daily and Simvastatin 80mg once daily Aspirin, Losartan and Simvastatin Aspirin Aspirin 150mg once daily, Losartan 100mg once daily and Simvastatin 80mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period. Aspirin, Losartan and Simvastatin Losartan Aspirin 150mg once daily, Losartan 100mg once daily and Simvastatin 80mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period. Aspirin, Losartan and Simvastatin Simvastatin Aspirin 150mg once daily, Losartan 100mg once daily and Simvastatin 80mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
- Primary Outcome Measures
Name Time Method Death up to 28 days of randomisation Cause of death will be described
- Secondary Outcome Measures
Name Time Method Myocardial infarction up to 28 days of randomisation Congestive cardiac failure up to 28 days of randomisation Myocarditis up to 28 days of randomisation Viral pneumonitis up to 28 days of randomisation Acute renal failure up to 28 days of randomisation Sepsis up to 28 days of randomisation Stroke up to 28 days of randomisation Severe cardiac arrythmia up to 28 days of randomisation Respiratory failure including ARDS 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
Trial Locations
- Locations (2)
University College Hospital
š³š¬Ibadan, Oyo, Nigeria
Shifa Tameer-e-Millat University
šµš°Rawalpindi, Pakistan