Coronavirus Response - Active Support for Hospitalised Covid-19 Patients

Covid-19 Clinical Trial

— CRASH-19  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04343001
• Other study ID #: 2020-KEP-420
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 2020
• Est. completion date: August 2021

Study information

• Verified date: April 2020
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19

Intervention

Drug:
• Aspirin
Aspirin 150mg
• Losartan
Losartan 100mg
• Simvastatin
Simvastatin 80mg

Locations

Country	Name	City	State
Nigeria	University College Hospital	Ibadan	Oyo
Pakistan	Shifa Tameer-e-Millat University	Rawalpindi

Sponsors (1)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine

Countries where clinical trial is conducted

Nigeria,  Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Cause of death will be described	up to 28 days of randomisation
Secondary	Myocardial infarction		up to 28 days of randomisation
Secondary	Congestive cardiac failure		up to 28 days of randomisation
Secondary	Severe cardiac arrythmia		up to 28 days of randomisation
Secondary	Myocarditis		up to 28 days of randomisation
Secondary	Respiratory failure including ARDS		up to 28 days of randomisation
Secondary	Viral pneumonitis		up to 28 days of randomisation
Secondary	Acute renal failure		up to 28 days of randomisation
Secondary	Sepsis		up to 28 days of randomisation
Secondary	Stroke		up to 28 days of randomisation
Secondary	Gastrointestinal bleeding		up to 28 days of randomisation
Secondary	Receipt of non invasive or mechanical ventilation		up to 28 days of randomisation
Secondary	Ability to self care at hospital discharge		up to 28 days of randomisation