CRASH-19: Coronavirus Response - Active Support for Hospitalised Covid-19 Patients

Sponsor

London School of Hygiene and Tropical Medicine (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04343001

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid-19	Drug: Aspirin Drug: Losartan Drug: Simvastatin	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

2 x 2 x 22 x 2 x 2

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard care Usual standard of care at the study hospital
Experimental: Aspirin Aspirin 150mg once daily	Drug: Aspirin Aspirin 150mg
Experimental: Losartan Losartan 100mg once daily. Dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.	Drug: Losartan Losartan 100mg
Experimental: Simvastatin Simvastatin 80mg once daily	Drug: Simvastatin Simvastatin 80mg
Experimental: Aspirin and 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.	Drug: Aspirin Aspirin 150mg Drug: Losartan Losartan 100mg
Experimental: Aspirin and Simvastatin Aspirin 150mg once daily and Simvastatin 80mg once daily	Drug: Aspirin Aspirin 150mg Drug: Simvastatin Simvastatin 80mg
Experimental: Losartan and 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.	Drug: Losartan Losartan 100mg Drug: Simvastatin Simvastatin 80mg
Experimental: Aspirin, Losartan and 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.	Drug: Aspirin Aspirin 150mg Drug: Losartan Losartan 100mg Drug: Simvastatin Simvastatin 80mg

Outcome Measures

Primary Outcome Measures

Death [up to 28 days of randomisation]
Cause of death will be described

Secondary Outcome Measures

Myocardial infarction [up to 28 days of randomisation]
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]
Acute renal failure [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University College Hospital	Ibadan	Oyo	Nigeria
2	Shifa Tameer-e-Millat University	Rawalpindi		Pakistan

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

Investigators

Study Chair: Haleema Shakur-Still, London School of Hygiene and Tropical Medicine
Study Chair: Ian Roberts, London School of Hygiene and Tropical Medicine