Clinical trial NCT04343001: Coronavirus Response - Active Support for Hospitalised Covid-19 Patients
Official title: Aspirin, Losartan and Simvastatin in Hospitalised COVID-19 Patients: a Multinational Randomised Open-label Factorial Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Covid-19
Keywords: Adult Respiratory Distress Syndrome
Pneumonia
Myocardial infarction
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 x 2 x 2
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Death
timeFrame: up to 28 days of randomisation
Secondary outcomes:
measure: Myocardial infarction
timeFrame: up to 28 days of randomisation
measure: Congestive cardiac failure
timeFrame: up to 28 days of randomisation
measure: Severe cardiac arrythmia
timeFrame: up to 28 days of randomisation
measure: Myocarditis
timeFrame: up to 28 days of randomisation
measure: Respiratory failure including ARDS
timeFrame: up to 28 days of randomisation
measure: Viral pneumonitis
timeFrame: up to 28 days of randomisation
measure: Acute renal failure
timeFrame: up to 28 days of randomisation
measure: Sepsis
timeFrame: up to 28 days of randomisation
measure: Stroke
timeFrame: up to 28 days of randomisation
measure: Gastrointestinal bleeding
timeFrame: up to 28 days of randomisation
measure: Receipt of non invasive or mechanical ventilation
timeFrame: up to 28 days of randomisation
measure: Ability to self care at hospital discharge
timeFrame: up to 28 days of randomisation
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: University College Hospital
state: Oyo
city: Rawalpindi
country: Pakistan
facility: Shifa Tameer-e-Millat University
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Haleema Shakur-Still
role: STUDY_CHAIR
affiliation: London School of Hygiene and Tropical Medicine
name: Ian Roberts
role: STUDY_CHAIR
References: