Back to resultsCoronavirus Response - Active Support for Hospitalised Covid-19 Patients (CRASH-19)
Primary Purpose
Covid-19
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aspirin
Losartan
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Covid-19 focused on measuring Adult Respiratory Distress Syndrome, Pneumonia, Myocardial infarction
Eligibility Criteria
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.
Sites / Locations
- University College Hospital
- Shifa Tameer-e-Millat University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
No Intervention
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Standard care
Aspirin
Losartan
Simvastatin
Aspirin and Losartan
Aspirin and Simvastatin
Losartan and Simvastatin
Aspirin, Losartan and Simvastatin
Arm Description
Usual standard of care at the study hospital
Aspirin 150mg once daily
Losartan 100mg once daily. Dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
Simvastatin 80mg once daily
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 once daily and Simvastatin 80mg 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 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.
Outcomes
Primary Outcome Measures
Death
Cause of death will be described
Secondary Outcome Measures
Myocardial infarction
Congestive cardiac failure
Severe cardiac arrythmia
Myocarditis
Respiratory failure including ARDS
Viral pneumonitis
Acute renal failure
Sepsis
Stroke
Gastrointestinal bleeding
Receipt of non invasive or mechanical ventilation
Ability to self care at hospital discharge
Full Information
NCT ID
NCT04343001
First Posted
April 8, 2020
Last Updated
November 17, 2020
Sponsor
London School of Hygiene and Tropical Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04343001
Brief Title
Coronavirus Response - Active Support for Hospitalised Covid-19 Patients
Acronym
CRASH-19
Official Title
Aspirin, Losartan and Simvastatin in Hospitalised COVID-19 Patients: a Multinational Randomised Open-label Factorial Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Grant not obtained
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
Adult Respiratory Distress Syndrome, Pneumonia, Myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Model Description
2 x 2 x 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Usual standard of care at the study hospital
Arm Title
Aspirin
Arm Type
Experimental
Arm Description
Aspirin 150mg once daily
Arm Title
Losartan
Arm Type
Experimental
Arm Description
Losartan 100mg once daily. Dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
Arm Title
Simvastatin
Arm Type
Experimental
Arm Description
Simvastatin 80mg once daily
Arm Title
Aspirin and Losartan
Arm Type
Experimental
Arm 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.
Arm Title
Aspirin and Simvastatin
Arm Type
Experimental
Arm Description
Aspirin 150mg once daily and Simvastatin 80mg once daily
Arm Title
Losartan and Simvastatin
Arm Type
Experimental
Arm 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.
Arm Title
Aspirin, Losartan and Simvastatin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 150mg
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
Losartan 100mg
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
Simvastatin 80mg
Primary Outcome Measure Information:
Title
Death
Description
Cause of death will be described
Time Frame
up to 28 days of randomisation
Secondary Outcome Measure Information:
Title
Myocardial infarction
Time Frame
up to 28 days of randomisation
Title
Congestive cardiac failure
Time Frame
up to 28 days of randomisation
Title
Severe cardiac arrythmia
Time Frame
up to 28 days of randomisation
Title
Myocarditis
Time Frame
up to 28 days of randomisation
Title
Respiratory failure including ARDS
Time Frame
up to 28 days of randomisation
Title
Viral pneumonitis
Time Frame
up to 28 days of randomisation
Title
Acute renal failure
Time Frame
up to 28 days of randomisation
Title
Sepsis
Time Frame
up to 28 days of randomisation
Title
Stroke
Time Frame
up to 28 days of randomisation
Title
Gastrointestinal bleeding
Time Frame
up to 28 days of randomisation
Title
Receipt of non invasive or mechanical ventilation
Time Frame
up to 28 days of randomisation
Title
Ability to self care at hospital discharge
Time Frame
up to 28 days of randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haleema Shakur-Still
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ian Roberts
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University College Hospital
City
Ibadan
State/Province
Oyo
Country
Nigeria
Facility Name
Shifa Tameer-e-Millat University
City
Rawalpindi
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://freebird.lshtm.ac.uk
Learn more about this trial
Coronavirus Response - Active Support for Hospitalised Covid-19 Patients
We'll reach out to this number within 24 hrs