Severe Acute Respiratory SyndromePhase 2RECOVERNCT04470544
Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19
A Phase 2 study testing Camostat Mesilate in people with Severe Acute Respiratory Syndrome, run by Alan Bryce at 2 sites in United States.
Trial summary
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome
- What is being tested?
- Camostat Mesilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2020to 20 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laboratory confirmed SARS-CoV-2 infection
- Admitted to hospital for management of SARS-CoV-2
- Age ≥18
- Subject or legal representative able to give informed consent
- Ability to take all study drugs
- Respiratory status of 3 or greater on the WHO ordinal scale
Show all 9Show fewer
- ALT or AST ≤5 x ULN
- Creatinine clearance ≥50 mL/min using the Cockroft-Gault formula
- Willingness to provide mandatory specimens for correlative research and banking
Who cannot join
- Women who are pregnant or breastfeeding
- Known hypersensitivity to the study drug, the metabolites or formulation excipient
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Tucson Medical Center
Tucson, Arizona, 85712
About this study
Official title: RECOVER: Phase 2 Randomized, Double-Blind Trial TREating Hospitalized Patients With COVID-19 With Camostat MesilatE, a TMPRSS2 Inhibitor
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
- Conditions
- Severe Acute Respiratory Syndrome
- Being tested
- Camostat Mesilate, Standard of Care
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camostat MesilateDrug
Also called Foipan
Given PO
Standard of CareOther
At Investigator discretion
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Standard of Care | Placebo comparator | Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo. Receives: Other: Standard of Care |
| Camostat + Standard of Care | Experimental | Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment. Receives: Drug: Camostat Mesilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Alive and Free From Respiratory Failure
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
Measured: 28 Days
Secondary outcomes (4)
Proportion of Patients Alive and Free of Ventilator Use or ECMO
To determine if reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with SOC treatment will change the proportion of patients alive and free of ventilator use or ECMO at Day 28 as compared to SOC treatment combined with placebo.
Measured: 28 Days
Mortality Rate
To determine if the combination of Camostat mesilate combined with SOC treatment will result in a changed mortality rate at 28 days as compared to SOC treatment combined with placebo.
Measured: 28 Days
Clinical Change
Clinical change will be defined as a 2 or more point decease on the WHO ordinal scale. The WHO ordinal scale ranges from 0, the best status, to 8, death. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change.
Measured: 28 Days
Adverse Event Grade 3 Plus Rate
Analyses for safety will include all participants who are randomized and received at least 1 dose of study treatment. Participants will be grouped according to the treatment to which they were randomized.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start28 Jul 2020
- Primary completion22 Dec 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe Acute Respiratory SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alan Bryce
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alan Bryce, Academic and Community Cancer Research United
- Investigators
- Alan H Bryce, M.D., Principal investigator, Academic and Community Cancer Research United
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470544
- Sponsor's protocol ID
- CAM20CV
- Acronym
- RECOVER
- Status last verified
- Feb 2024
- First submitted
- 9 Jul 2020
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECOVER: Phase 2 Randomized, Double-Blind Trial TREating Hospitalized Patients With COVID-19 With Camostat MesilatE, a TMPRSS2 Inhibitor
- ClinicalTrials.gov ID
- NCT04470544
- Acronym / sponsor ID
- RECOVER / CAM20CV
- Conditions
- Severe Acute Respiratory Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alan BryceUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + Standard of Care | Placebo comparator | Other: Standard of CareStandard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo. |
| Camostat + Standard of Care | Experimental | Drug: Camostat MesilatePatient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Laboratory confirmed SARS-CoV-2 infection
- Admitted to hospital for management of SARS-CoV-2
- Age ≥18
- Subject or legal representative able to give informed consent
- Ability to take all study drugs
Key exclusion criteria (2 listed)
- Women who are pregnant or breastfeeding
- Known hypersensitivity to the study drug, the metabolites or formulation excipient
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 |
|---|---|---|
| Camostat MesilateAlso: FoipanGiven PO | Drug | Camostat + Standard of Care |
| Standard of CareAt Investigator discretion | Other | Placebo + Standard of Care |
Primary outcome
Proportion of Patients Alive and Free From Respiratory Failure
Time frame: 28 Days
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
4 secondary outcomes
Proportion of Patients Alive and Free of Ventilator Use or ECMO
Time frame: 28 Days
Mortality Rate
Time frame: 28 Days
Clinical Change
Time frame: 28 Days
Adverse Event Grade 3 Plus Rate
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alan H Bryce, M.D. principal investigator
Academic and Community Cancer Research United
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camostat Mesilate in people with Severe Acute Respiratory Syndrome, run by Alan Bryce at 2 sites in United States.
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 9 inclusion and 2 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: finished, as of the sponsor's last update on 12 Nov 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients Alive and Free From Respiratory Failure (time frame: 28 Days). 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 12 Nov 2024.