Covid19Phase 1COMBONCT04652765
Camostat With Bicalutamide for COVID-19
A Phase 1 study testing Camostat Mesilate and Bicalutamide 150 mg in people with Covid19 and SARS-CoV Infection, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This will be a randomized, open-label study to determine if camostat+ bicalutamide decreases the proportion of people with COVID-19 who require hospitalization, compared to historical controls. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection, Coronavirus Infection
- What is being tested?
- Camostat Mesilate and Bicalutamide 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 15 Sep 2021
- Phase
- Phase 1
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 60 years of age
- COVID-19 infection, confirmed by polymerase chain reaction (PCR) test <=5 days from enrollment done in the ambulatory setting
- Able to provide informed consent
- Symptom related to COVID-19. This includes: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea or other symptom recognized by the Centers for Disease Control to be a symptom of COVID-19.
Who cannot join
- Patients who undergo asymptomatic screening test that is positive and remain asymptomatic during the eligible time window
- Patients who have had one or more positive more than 5 days prior to enrollment but within 60 days of enrollment (ex. if a patient has a positive test 10 days prior to enrollment and then a second positive test the day referred for enrollment, that patient would be excluded. If a patient had a positive test 5 months ago, and then another positive test the day he/she was referred for enrollment, that patient would be eligible)
- Unable to take oral medication
- Male patients with female partners of reproductive potential who are unable to maintain effective contraception during the recommended time period (during treatment and for 130 days after the final dose)
- Symptoms requiring hospitalization or immediate referral to hospital
- Taking bicalutamide, any systemic hormonal therapy, or camostat within one month of study entry
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- Known hypersensitivity to bicalutamide, or camostat, or its components.
- On coumadin anticoagulation (because of drug-drug interaction with bicalutamide)
- Self-reported past medical history of chronic liver disease or cirrhosis
- Self-reported myocardial infarction within 6 months or past medical history of congestive heart failure with known ejection fraction < 40%
- Taking any other investigational treatment for COVID-19 or COVID-19 prophylaxis (COVID-19 vaccines and treatments allowed under FDA Emergency Use Authorization are allowed.)
- Women and people from all ethnic and race groups are eligible for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMBO Trial: Camostat With Bicalutamide for COVID-19
This will be a randomized, open-label study to determine if camostat+ bicalutamide decreases the proportion of people with COVID-19 who require hospitalization, compared to historical controls. Patients with symptomatic COVID-19, diagnosed as outpatients, will be randomized 1:1, stratified by gender, to treatment with standard of care alone (Arm 1) or with camostat and bicalutamide (Arm 2).
- Conditions
- Covid19, SARS-CoV Infection, Coronavirus Infection
- Being tested
- Camostat Mesilate, Bicalutamide 150 mg
- Keywords
- COVID-19, Coronavirus, Camostat, bicalutamide, TMPRSS2, SARS-COV-2
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camostat MesilateDrug
Also called camostat
Camostat 600mg by mouth four times a day, for a total of 7 days
Bicalutamide 150 mgDrug
Bicalutamide 150mg by mouth once daily, for a total of 7 days
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (SOC) | No intervention | SARS-CoV-2 positive participants will receive SOC therapy alone. |
| SOC plus camostat | Active comparator | SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days. Receives: Drug: Camostat Mesilate |
| SOC plus camostat and bicalutamide | Active comparator | SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days. Receives: Drug: Camostat Mesilate; Drug: Bicalutamide 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Requiring Hospitalization
Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28
Measured: up to 28 days
Secondary outcomes (4)
Number of Participants Experiencing Symptoms
Measured: up to 21 days
Number of Drug-related Adverse Events
Number of adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
Measured: up to 60 days
Number of Drug-related Serious Adverse Events
Number of serious adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
Measured: up to 60 days
All-cause Mortality
Number of participants deceased.
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start3 Feb 2021
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Why it stopped: PI Decision to close/stop the study due to no new accrual.
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 Covid19Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine H Marshall, MD/MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652765
- Sponsor's protocol ID
- COV2005
- Other IDs
- IRB00254142
- Acronym
- COMBO
- Status last verified
- Oct 2023
- First submitted
- 2 Dec 2020
- Last updated
- 6 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMBO Trial: Camostat With Bicalutamide for COVID-19
- ClinicalTrials.gov ID
- NCT04652765
- Acronym / sponsor ID
- COMBO / COV2005
- Conditions
- Covid19, SARS-CoV Infection, Coronavirus Infection
- Keywords
- COVID-19, Coronavirus, Camostat, bicalutamide, TMPRSS2, SARS-COV-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Decision to close/stop the study due to no new accrual.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Posted 6 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized, open-label study to determine if camostat+ bicalutamide decreases the proportion of people with COVID-19 who require hospitalization, compared to historical controls. Patients with symptomatic COVID-19, diagnosed as outpatients, will be randomized 1:1, stratified by gender, to treatment with standard of care alone (Arm 1) or with camostat and bicalutamide (Arm 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of care (SOC) | No intervention | –SARS-CoV-2 positive participants will receive SOC therapy alone. |
| SOC plus camostat | Active comparator | Drug: Camostat MesilateSARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days. |
| SOC plus camostat and bicalutamide | Active comparator | Drug: Camostat Mesilate, Drug: Bicalutamide 150 mgSARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >= 60 years of age
- COVID-19 infection, confirmed by polymerase chain reaction (PCR) test <=5 days from enrollment done in the ambulatory setting
- Able to provide informed consent
- Symptom related to COVID-19. This includes: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea or other symptom recognized by the Centers for Disease Control to be a symptom of COVID-19.
Key exclusion criteria (12 listed)
- Patients who undergo asymptomatic screening test that is positive and remain asymptomatic during the eligible time window
- Patients who have had one or more positive more than 5 days prior to enrollment but within 60 days of enrollment (ex. if a patient has a positive test 10 days prior to enrollment and then a second positive test the day referred for enrollment, that patient would be excluded. If a patient had a positive test 5 months ago, and then another positive test the day he/she was referred for enrollment, that patient would be eligible)
- Unable to take oral medication
- Male patients with female partners of reproductive potential who are unable to maintain effective contraception during the recommended time period (during treatment and for 130 days after the final dose)
- Symptoms requiring hospitalization or immediate referral to hospital
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: camostatCamostat 600mg by mouth four times a day, for a total of 7 days | Drug | SOC plus camostat, SOC plus camostat and bicalutamide |
| Bicalutamide 150 mgBicalutamide 150mg by mouth once daily, for a total of 7 days | Drug | SOC plus camostat and bicalutamide |
Primary outcome
Number of Participants Requiring Hospitalization
Time frame: up to 28 days
Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28
4 secondary outcomes
Number of Participants Experiencing Symptoms
Time frame: up to 21 days
Number of Drug-related Adverse Events
Time frame: up to 60 days
Number of Drug-related Serious Adverse Events
Time frame: up to 60 days
All-cause Mortality
Time frame: up to 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Catherine H Marshall, MD/MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Camostat Mesilate and Bicalutamide 150 mg in people with Covid19 and SARS-CoV Infection, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 6 Oct 2023). 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?
Number of Participants Requiring Hospitalization (time frame: up to 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 6 Oct 2023; AzTrials last refreshed its copy on 31 Oct 2026.