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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Recruitment Status : Withdrawn (Grant not obtained)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

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2 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
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Death [ Time Frame: up to 28 days of randomisation ]
    Cause of death will be described


Secondary Outcome Measures :
  1. Myocardial infarction [ Time Frame: up to 28 days of randomisation ]
  2. Congestive cardiac failure [ Time Frame: up to 28 days of randomisation ]
  3. Severe cardiac arrythmia [ Time Frame: up to 28 days of randomisation ]
  4. Myocarditis [ Time Frame: up to 28 days of randomisation ]
  5. Respiratory failure including ARDS [ Time Frame: up to 28 days of randomisation ]
  6. Viral pneumonitis [ Time Frame: up to 28 days of randomisation ]
  7. Acute renal failure [ Time Frame: up to 28 days of randomisation ]
  8. Sepsis [ Time Frame: up to 28 days of randomisation ]
  9. Stroke [ Time Frame: up to 28 days of randomisation ]
  10. Gastrointestinal bleeding [ Time Frame: up to 28 days of randomisation ]
  11. Receipt of non invasive or mechanical ventilation [ Time Frame: up to 28 days of randomisation ]
  12. Ability to self care at hospital discharge [ Time Frame: up to 28 days of randomisation ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343001


Locations
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Nigeria
University College Hospital
Ibadan, Oyo, Nigeria
Pakistan
Shifa Tameer-e-Millat University
Rawalpindi, Pakistan
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
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Study Chair: Haleema Shakur-Still London School of Hygiene and Tropical Medicine
Study Chair: Ian Roberts London School of Hygiene and Tropical Medicine
More Information
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT04343001    
Other Study ID Numbers: 2020-KEP-420
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by London School of Hygiene and Tropical Medicine:
Adult Respiratory Distress Syndrome
Pneumonia
Myocardial infarction
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Aspirin
Losartan
Simvastatin
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics