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

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

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

Study Overview

Status

Withdrawn

Conditions

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oyo
      • Ibadan, Oyo, Nigeria
        • University College Hospital
      • Rawalpindi, Pakistan
        • Shifa Tameer-e-Millat University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard care
Usual standard of care at the study hospital
Experimental: Aspirin
Aspirin 150mg once daily
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.
Losartan 100mg
Experimental: Simvastatin
Simvastatin 80mg once daily
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.
Aspirin 150mg
Losartan 100mg
Experimental: Aspirin and Simvastatin
Aspirin 150mg once daily and Simvastatin 80mg once daily
Aspirin 150mg
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.
Losartan 100mg
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.
Aspirin 150mg
Losartan 100mg
Simvastatin 80mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: up to 28 days of randomisation
Cause of death will be described
up to 28 days of randomisation

Secondary Outcome Measures

Outcome Measure
Time Frame
Myocardial infarction
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation
Congestive cardiac failure
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation
Severe cardiac arrythmia
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation
Myocarditis
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation
Respiratory failure including ARDS
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation
Viral pneumonitis
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation
Acute renal failure
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation
Sepsis
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation
Stroke
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation
Gastrointestinal bleeding
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation
Receipt of non invasive or mechanical ventilation
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation
Ability to self care at hospital discharge
Time Frame: up to 28 days of randomisation
up to 28 days of randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

As many sites will contribute to this trial, individual sites cannot restrict the publication of the manuscript relating to the outcomes of this trial. All anonymised data from this trial will be made freely available on our data sharing site: http://freebird.lshtm.ac.uk.

IPD Sharing Time Frame

Within 6 months or sooner of publication

IPD Sharing Access Criteria

Log-in required for the sole purpose to monitor data download.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid-19

Clinical Trials on Aspirin

3
Subscribe