Coronavirus Response - Active Support for Hospitalised Covid-19 Patients

NCT04343001 | Withdrawn Phase 3 DMC

• 1 other identifier: 2020-KEP-420
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

Covid-19

Keywords

Adult Respiratory Distress Syndrome; Pneumonia; Myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Death

  Cause of death will be described

  up to 28 days of randomisation

Secondary Outcomes (12)

• Myocardial infarction

  up to 28 days of randomisation

• Congestive cardiac failure

  up to 28 days of randomisation

• Severe cardiac arrythmia

  up to 28 days of randomisation

• Myocarditis

  up to 28 days of randomisation

• Respiratory failure including ARDS

  up to 28 days of randomisation

Study Arms (8)

Standard care

NO INTERVENTION

Usual standard of care at the study hospital

Aspirin

EXPERIMENTAL

Aspirin 150mg once daily

Drug: Aspirin

Losartan

EXPERIMENTAL

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

Simvastatin

EXPERIMENTAL

Simvastatin 80mg once daily

Drug: Simvastatin

Aspirin and Losartan

EXPERIMENTAL

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; Drug: Losartan

Aspirin and Simvastatin

EXPERIMENTAL

Aspirin 150mg once daily and Simvastatin 80mg once daily

Drug: Aspirin; Drug: Simvastatin

Losartan and Simvastatin

EXPERIMENTAL

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; Drug: Simvastatin

Aspirin, Losartan and Simvastatin

EXPERIMENTAL

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; Drug: Losartan; Drug: Simvastatin

Interventions

Aspirin DRUG

Aspirin 150mg

Aspirin; Aspirin and Losartan; Aspirin and Simvastatin; Aspirin, Losartan and Simvastatin

Losartan DRUG

Losartan 100mg

Aspirin and Losartan; Aspirin, Losartan and Simvastatin; Losartan; Losartan and Simvastatin

Simvastatin DRUG

Simvastatin 80mg

Aspirin and Simvastatin; Aspirin, Losartan and Simvastatin; Losartan and Simvastatin; Simvastatin

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (2)

University College Hospital

Ibadan, Oyo State, Nigeria

Location

Shifa Tameer-e-Millat University

Rawalpindi, Pakistan

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome; Pneumonia; Myocardial Infarction

Interventions

Aspirin; Losartan; Simvastatin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Biphenyl Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Haleema Shakur-Still

  London School of Hygiene and Tropical Medicine

  STUDY CHAIR

• Ian Roberts

  London School of Hygiene and Tropical Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 x 2 x 2

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 19, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 6 months or sooner of publication
• Access Criteria: Log-in required for the sole purpose to monitor data download.

Locations

PA (1); NG (1)