Coronavirus Response - Active Support for Hospitalised Co... | NCT04343001

Studies
Coronavirus Response - Active Support for Hospitalised Covid-19 Patients

NCT04343001

Sponsor

London School of Hygiene and Tropical Medicine

Status

Withdrawn

Last Update Posted

Nov 19, 2020Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Covid-19

Interventions

Aspirin
Losartan
Simvastatin

Countries

Nigeria
Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Grant not obtained

Expanded Access Info

Start Date

Oct 2020Estimated

Primary Completion Date

Apr 2021Estimated

Completion Date

Aug 2021Estimated

First Submitted Date

Apr 8, 2020

First Submission Date that Met QC Criteria

Apr 10, 2020

First Posted Date

Apr 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2020

Last Update Posted Date

Nov 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspirin	Drug	Aspirin 150mg	Aspirin Aspirin and Losartan Aspirin and Simvastatin Aspirin, Losartan and Simvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death	Cause of death will be described	up to 28 days of randomisation

Secondary Outcomes

Measure	Description	Time Frame
Myocardial infarction		up to 28 days of randomisation
Congestive cardiac failure		up to 28 days of randomisation
Severe cardiac arrythmia

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haleema Shakur-Still	London School of Hygiene and Tropical Medicine	Study Chair
Ian Roberts	London School of Hygiene and Tropical Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University College Hospital		Ibadan	Oyo State		Nigeria
Shifa Tameer-e-Millat University

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

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

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D012128	Respiratory Distress Syndrome
D011014	Pneumonia
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001241	Aspirin
D019808	Losartan
D019821	Simvastatin

Ancestor Terms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided