Coronavirus Response - Active Support for Hospitalised Covid-19 Patients (CRASH-19)

London School of Hygiene and Tropical Medicine

Status and phase: Withdrawn; Phase 3

Conditions: Covid-19

Treatments: Drug: Simvastatin; Drug: Losartan; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT04343001

2020-KEP-420

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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0 participants in 8 patient groups

Standard care

No Intervention group

Description:

Usual standard of care at the study hospital

Aspirin

Experimental group

Description:

Aspirin 150mg once daily

Treatment:

Drug: Aspirin

Losartan

Experimental group

Description:

Losartan 100mg once daily. Dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.

Treatment:

Drug: Losartan

Simvastatin

Experimental group

Description:

Simvastatin 80mg once daily

Treatment:

Drug: Simvastatin

Aspirin and Losartan

Experimental group

Description:

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.

Treatment:

Drug: Aspirin

Drug: Losartan

Aspirin and Simvastatin

Experimental group

Description:

Aspirin 150mg once daily and Simvastatin 80mg once daily

Treatment:

Drug: Aspirin

Drug: Simvastatin

Losartan and Simvastatin

Experimental group

Description:

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.

Treatment:

Drug: Simvastatin

Drug: Losartan

Aspirin, Losartan and Simvastatin

Experimental group

Description:

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.

Treatment:

Drug: Aspirin

Drug: Simvastatin

Drug: Losartan