Coronavirus Response - Active Support for Hospitalised Covid-19 Patients
NCT ID: NCT04343001
Last Updated: 2020-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2020-10-31
2021-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Standard care
Usual standard of care at the study hospital
No interventions assigned to this group
Aspirin
Aspirin 150mg once daily
Aspirin
Aspirin 150mg
Losartan
Losartan 100mg once daily. Dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
Losartan
Losartan 100mg
Simvastatin
Simvastatin 80mg once daily
Simvastatin
Simvastatin 80mg
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.
Aspirin
Aspirin 150mg
Losartan
Losartan 100mg
Aspirin and Simvastatin
Aspirin 150mg once daily and Simvastatin 80mg once daily
Aspirin
Aspirin 150mg
Simvastatin
Simvastatin 80mg
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.
Losartan
Losartan 100mg
Simvastatin
Simvastatin 80mg
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.
Aspirin
Aspirin 150mg
Losartan
Losartan 100mg
Simvastatin
Simvastatin 80mg
Interventions
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Aspirin
Aspirin 150mg
Losartan
Losartan 100mg
Simvastatin
Simvastatin 80mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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Principal Investigators
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Haleema Shakur-Still
Role: STUDY_CHAIR
London School of Hygiene and Tropical Medicine
Ian Roberts
Role: STUDY_CHAIR
London School of Hygiene and Tropical Medicine
Locations
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University College Hospital
Ibadan, Oyo State, Nigeria
Shifa Tameer-e-Millat University
Rawalpindi, , Pakistan
Countries
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Other Identifiers
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2020-KEP-420
Identifier Type: -
Identifier Source: org_study_id