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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343001
Recruitment Status : Withdrawn (Grant not obtained)
First Posted : April 13, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE April 8, 2020
First Posted Date  ICMJE April 13, 2020
Last Update Posted Date November 19, 2020
Estimated Study Start Date  ICMJE October 2020
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
Death [ Time Frame: up to 28 days of randomisation ]
Cause of death will be described
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
  • Myocardial infarction [ Time Frame: up to 28 days of randomisation ]
  • Congestive cardiac failure [ Time Frame: up to 28 days of randomisation ]
  • Severe cardiac arrythmia [ Time Frame: up to 28 days of randomisation ]
  • Myocarditis [ Time Frame: up to 28 days of randomisation ]
  • Respiratory failure including ARDS [ Time Frame: up to 28 days of randomisation ]
  • Viral pneumonitis [ Time Frame: up to 28 days of randomisation ]
  • Acute renal failure [ Time Frame: up to 28 days of randomisation ]
  • Sepsis [ Time Frame: up to 28 days of randomisation ]
  • Stroke [ Time Frame: up to 28 days of randomisation ]
  • Gastrointestinal bleeding [ Time Frame: up to 28 days of randomisation ]
  • Receipt of non invasive or mechanical ventilation [ Time Frame: up to 28 days of randomisation ]
  • Ability to self care at hospital discharge [ Time Frame: up to 28 days of randomisation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coronavirus Response - Active Support for Hospitalised Covid-19 Patients
Official Title  ICMJE Aspirin, Losartan and Simvastatin in Hospitalised COVID-19 Patients: a Multinational Randomised Open-label Factorial Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
2 x 2 x 2
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid-19
Intervention  ICMJE
  • Drug: Aspirin
    Aspirin 150mg
  • Drug: Losartan
    Losartan 100mg
  • Drug: Simvastatin
    Simvastatin 80mg
Study Arms  ICMJE
  • No Intervention: Standard care
    Usual standard of care at the study hospital
  • Experimental: Aspirin
    Aspirin 150mg once daily
    Intervention: Drug: Aspirin
  • 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.
    Intervention: Drug: Losartan
  • Experimental: Simvastatin
    Simvastatin 80mg once daily
    Intervention: Drug: Simvastatin
  • 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.
    Interventions:
    • Drug: Aspirin
    • Drug: Losartan
  • Experimental: Aspirin and Simvastatin
    Aspirin 150mg once daily and Simvastatin 80mg once daily
    Interventions:
    • Drug: Aspirin
    • Drug: Simvastatin
  • 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.
    Interventions:
    • Drug: Losartan
    • Drug: Simvastatin
  • 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.
    Interventions:
    • Drug: Aspirin
    • Drug: Losartan
    • Drug: Simvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 17, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2020)
10000
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nigeria,   Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04343001
Other Study ID Numbers  ICMJE 2020-KEP-420
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Within 6 months or sooner of publication
Access Criteria: Log-in required for the sole purpose to monitor data download.
URL: http://freebird.lshtm.ac.uk
Responsible Party London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Haleema Shakur-Still London School of Hygiene and Tropical Medicine
Study Chair: Ian Roberts London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP