Coronavirus Response - Active Support for Hospitalised Covid-19 Patients (CRASH-19)
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ClinicalTrials.gov Identifier: NCT04343001 |
Recruitment Status :
Withdrawn
(Grant not obtained)
First Posted : April 13, 2020
Last Update Posted : November 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid-19 | Drug: Aspirin Drug: Losartan Drug: Simvastatin | Phase 3 |
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 (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 |

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 |
- Death [ Time Frame: up to 28 days of randomisation ]Cause of death will be described
- 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 ]

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Nigeria | |
University College Hospital | |
Ibadan, Oyo, Nigeria | |
Pakistan | |
Shifa Tameer-e-Millat University | |
Rawalpindi, Pakistan |
Study Chair: | Haleema Shakur-Still | London School of Hygiene and Tropical Medicine | |
Study Chair: | Ian Roberts | London School of Hygiene and Tropical Medicine |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Adult Respiratory Distress Syndrome Pneumonia Myocardial infarction |
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 |