Covid-19Phase 3CRASH-19NCT04343001
Coronavirus Response - Active Support for Hospitalised Covid-19 Patients
A Phase 3 study testing Aspirin, Losartan and Simvastatin in people with Covid-19, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial summary
The CRASH-19 trial is a multinational, open-label, factorial, randomised trial in adults hospitalised with suspected or confirmed acute COVID-19 infection. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- Aspirin, Losartan and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2020to Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Aspirin, Losartan and Simvastatin in Hospitalised COVID-19 Patients: a Multinational Randomised Open-label Factorial Trial
The CRASH-19 trial is a multinational, open-label, factorial, randomised trial in adults hospitalised with suspected or confirmed acute COVID-19 infection.
Read the 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.
- Conditions
- Covid-19
- Being tested
- Aspirin, Losartan, Simvastatin
- Keywords
- Adult Respiratory Distress Syndrome, Pneumonia, Myocardial infarction
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Pneumonia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin 150mg
LosartanDrug
Losartan 100mg
SimvastatinDrug
Simvastatin 80mg
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Usual standard of care at the study hospital |
| Aspirin | Experimental | Aspirin 150mg once daily Receives: 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. Receives: Drug: Losartan |
| Simvastatin | Experimental | Simvastatin 80mg once daily Receives: 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. Receives: Drug: Aspirin; Drug: Losartan |
| Aspirin and Simvastatin | Experimental | Aspirin 150mg once daily and Simvastatin 80mg once daily Receives: 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. Receives: 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. Receives: Drug: Aspirin; Drug: Losartan; Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Cause of death will be described
Measured: up to 28 days of randomisation
Secondary outcomes (12)
Myocardial infarction
Measured: up to 28 days of randomisation
Congestive cardiac failure
Measured: up to 28 days of randomisation
Severe cardiac arrythmia
Measured: up to 28 days of randomisation
Myocarditis
Measured: up to 28 days of randomisation
Respiratory failure including ARDS
Measured: up to 28 days of randomisation
Viral pneumonitis
Measured: up to 28 days of randomisation
Acute renal failure
Measured: up to 28 days of randomisation
Sepsis
Measured: up to 28 days of randomisation
Stroke
Measured: up to 28 days of randomisation
Gastrointestinal bleeding
Measured: up to 28 days of randomisation
Receipt of non invasive or mechanical ventilation
Measured: up to 28 days of randomisation
Ability to self care at hospital discharge
Measured: up to 28 days of randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study startOct 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: Grant not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2 x 2
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haleema Shakur-Still, Study chair, London School of Hygiene and Tropical MedicineIan Roberts, Study chair, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343001
- Sponsor's protocol ID
- 2020-KEP-420
- Acronym
- CRASH-19
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin, Losartan and Simvastatin in Hospitalised COVID-19 Patients: a Multinational Randomised Open-label Factorial Trial
- ClinicalTrials.gov ID
- NCT04343001
- Acronym / sponsor ID
- CRASH-19 / 2020-KEP-420
- Conditions
- Covid-19
- Keywords
- Adult Respiratory Distress Syndrome, Pneumonia, Myocardial infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant not obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- 2 x 2 x 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Usual standard of care at the study hospital |
| Aspirin | Experimental | Drug: AspirinAspirin 150mg once daily |
| Losartan | Experimental | Drug: LosartanLosartan 100mg once daily. Dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period. |
| Simvastatin | Experimental | Drug: SimvastatinSimvastatin 80mg once daily |
| Aspirin and Losartan | Experimental | Drug: Aspirin, Drug: LosartanAspirin 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 and Simvastatin | Experimental | Drug: Aspirin, Drug: SimvastatinAspirin 150mg once daily and Simvastatin 80mg once daily |
| Losartan and Simvastatin | Experimental | Drug: Losartan, Drug: SimvastatinLosartan 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, Losartan and Simvastatin | Experimental | Drug: Aspirin, Drug: Losartan, Drug: SimvastatinAspirin 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAspirin 150mg | Drug | Aspirin, Aspirin and Losartan, Aspirin and Simvastatin, Aspirin, Losartan and Simvastatin |
| LosartanLosartan 100mg | Drug | Aspirin and Losartan, Aspirin, Losartan and Simvastatin, Losartan, Losartan and Simvastatin |
| SimvastatinSimvastatin 80mg | Drug | Aspirin and Simvastatin, Aspirin, Losartan and Simvastatin, Losartan and Simvastatin, Simvastatin |
Primary outcome
Death
Time frame: up to 28 days of randomisation
Cause of death will be described
12 secondary outcomes
Myocardial infarction
Time frame: up to 28 days of randomisation
Congestive cardiac failure
Time frame: up to 28 days of randomisation
Severe cardiac arrythmia
Time frame: up to 28 days of randomisation
Myocarditis
Time frame: up to 28 days of randomisation
Respiratory failure including ARDS
Time frame: up to 28 days of randomisation
Viral pneumonitis
Time frame: up to 28 days of randomisation
Acute renal failure
Time frame: up to 28 days of randomisation
Sepsis
Time frame: up to 28 days of randomisation
Stroke
Time frame: up to 28 days of randomisation
Gastrointestinal bleeding
Time frame: up to 28 days of randomisation
Receipt of non invasive or mechanical ventilation
Time frame: up to 28 days of randomisation
Ability to self care at hospital discharge
Time frame: up to 28 days of randomisation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haleema Shakur-Still study chair
London School of Hygiene and Tropical Medicine
Ian Roberts study chair
London School of Hygiene and Tropical Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin, Losartan and Simvastatin in people with Covid-19, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: up to 28 days of randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.