- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04343001
Coronavirus Response - Active Support for Hospitalised Covid-19 Patients (CRASH-19)
Aspirin, Losartan and Simvastatin in Hospitalised COVID-19 Patients: a Multinational Randomised Open-label Factorial Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 3
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard care
Usual standard of care at the study hospital
|
|
Experimental: Aspirin
Aspirin 150mg once daily
|
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.
|
Losartan 100mg
|
Experimental: Simvastatin
Simvastatin 80mg once daily
|
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.
|
Aspirin 150mg
Losartan 100mg
|
Experimental: Aspirin and Simvastatin
Aspirin 150mg once daily and Simvastatin 80mg once daily
|
Aspirin 150mg
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.
|
Losartan 100mg
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.
|
Aspirin 150mg
Losartan 100mg
Simvastatin 80mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: up to 28 days of randomisation
|
Cause of death will be described
|
up to 28 days of randomisation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Myocardial infarction
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Congestive cardiac failure
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Severe cardiac arrythmia
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Myocarditis
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Respiratory failure including ARDS
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Viral pneumonitis
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Acute renal failure
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Sepsis
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Stroke
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Gastrointestinal bleeding
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Receipt of non invasive or mechanical ventilation
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Ability to self care at hospital discharge
Time Frame: up to 28 days of randomisation
|
up to 28 days of randomisation
|
Collaborators and Investigators
Investigators
- Study Chair: Haleema Shakur-Still, London School of Hygiene and Tropical Medicine
- Study Chair: Ian Roberts, London School of Hygiene and Tropical Medicine
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Aspirin
- Losartan
- Simvastatin
Other Study ID Numbers
- 2020-KEP-420
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin... and other collaboratorsRecruitingCOVID-19 | Post-COVID-19 Syndrome | Post-Acute COVID-19 | Acute COVID-19China
Clinical Trials on Aspirin
-
The First Affiliated Hospital with Nanjing Medical...UnknownCoronary AtherosclerosisChina
-
Seoul National University HospitalCKD Pharmaceutical LimitedCompleted
-
Queen Mary University of LondonCancer Research UK; Barts and the London School of Medicine and DentistryCompletedProstate CancerUnited Kingdom
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingPulmonary Disease, Chronic ObstructiveUnited States
-
FANG HERecruitingPreeclampsia | Perinatal HaemorrhageChina
-
University of VigoRecruiting
-
Seoul National University HospitalCompletedCoronary Artery DiseaseKorea, Republic of
-
Seoul National University HospitalCompletedHealthyKorea, Republic of
-
PLx PharmaCompletedDiabetes Mellitus, Type 2United States
-
Boehringer IngelheimCompletedCoronary ArteriosclerosisIreland