COVIDPhase 4CLOCCNCT04338906
Combination Therapy With Camostat Mesilate + Hydroxychloroquine for COVID-19
A Phase 4 study testing Camostat Mesilate and Hydroxychloroquine in people with COVID, run by Heinrich-Heine University, Duesseldorf.
Trial summary
Evaluation of the efficacy and safety of hydroxychloroquine - camostat combination therapy in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial Primary Objectives: The primary objective of this study is to demonstrate, that a combination therapy of hydroxychloroquine and camostat (Foipan®) is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- What is being tested?
- Camostat Mesilate and Hydroxychloroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Dec 2021
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants ≥18 years of age with SARS-CoV-2 infection confirmed by PCR before randomization
- Willing and able to provide written informed consent
- Hospitalized and requiring medical care for COVID-19, (status 3 or 4 of 7-point ordinal clinical status scale)
- SpO2 ≥93% on room air
- Evidence of pulmonary infiltrate on chest X ray/and or CT scan
Who cannot join
- Age <18 years old
- Pregnant or breast feeding
- Inability to take oral medication
- Inability to provide informed written consent
- Known hypersensitivity towards 4-aminoquinolines, e.g. hydroxychloroquine and/or camostat
- Use of hydroxychloroquine, chloroquine and or camostat within 6 months prior to baseline
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- Patients with known retinopathy or macular degeneration Patients with known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Prolonged QTc-interval in baseline ECG (>500 ms)
- Concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration
- Major comorbidities, possibly leading to increased unwanted side effects of study drugs:
About this study
Official title: Evaluation of the Efficacy and Safety of Camostat Mesilate + Hydroxychloroquine Combination Therapy in Hospitalized Patients With Moderate COVID-19 Infection
Evaluation of the efficacy and safety of hydroxychloroquine - camostat combination therapy in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial Primary Objectives: The primary objective of this study is to demonstrate, that a combination therapy of hydroxychloroquine and camostat (Foipan®) is superior to hydroxychloroquine + placebo in participants with moderate COVID-19.
Read the detailed description
The ongoing pandemic with the novel coronavirus (SARS-CoV-2) poses a massive threat to public health. SARS-CoV-2 is highly contagious and may lead to severe acute respiratory distress syndrome in affected individuals. No therapeutic intervention has yet been approved for COVID-19, and initial interventional studies with single agents showed only minimal improvement in outcome or were not convincing in design. Therefore, the CLOCC trial will evaluate the efficacy and safety of a combination therapy consisting of hydroxychloroquine, which was used already as single agent with some effect, together with camostat mesylate in hospitalized patients with moderate COVID-19 infection. The rationale for this combination therapy stems from the observation that hydroxychloroquine interferes with viral entry and replication through several mechanisms including changes in endosomal pH and in glycosylation of the ACE2 receptor, which serves as entry receptor for SARS-CoV-2. Camostat acts as inhibitor of the host cell serine protease TMPRSS2, which is needed to prime the viral S protein for cell entry. Participants will be recruited in a total of 6 German centers, and the trial will be randomized (1:1) and enrolled in either the hydroxychloroquine + placebo or the hydroxychloroquine + camostat arm (7-day treatment). The trial will be carried out in a double-blinded fashion. The primary efficacy outcome is the number of patients discharged by day 14 (status 1 and 2 of a 7-point ordinal clinical status scale). Several secondary outcomes regarding efficacy but also safety will be evaluated. Exploratory endpoints include analysis of viral titers and the emergence of viral resistance in response to therapy.
- Conditions
- COVID
- Being tested
- Camostat Mesilate, Placebo, Hydroxychloroquine
- Keywords
- Camostat, Hydroxychloroquine, Moderate COVID-10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camostat MesilateDrug
400 mg tid, d1-d7
PlaceboDrug
Instead of Camostat Mesilate, tid, d1-d7
400 mg bid on day 1, 200 mg bid d2-d7
| Study group | Role | What they receive |
|---|---|---|
| Camostat + Hydroxychloroquine | Experimental | Subjects will receive Camostat (400 mg tid) + hydroxychloroquine (400 mg bid day1, 200 mg bid d2-d7) Receives: Drug: Camostat Mesilate; Drug: Hydroxychloroquine |
| Placebo + Hydroxychloroquine | Active comparator | Subjects will receive placebo (tid) + hydroxychloroquine (400 mg bid day1, 200 mg bid d2-d7) Receives: Drug: Placebo; Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Not hospitalized
Measured: day 14 from baseline
Secondary outcomes (10)
Time to improvement of 2 categories from admission on a 7-point ordinal scale
Measured: day 14
Proportion of participants in each group with normalization of fever
Measured: day 7 and day 14
Proportion of participants in each group with oxygen saturation > 94% on room air for >24h
Measured: day 7 and day 14
Time to fever normalization (if febrile at baseline)
Measured: within 14 days
Time to first negative SARS-CoV-2 PCR in NP swap (if pos. at baseline)
Measured: within 14 days
Time to first negative SARS-CoV-2 PCR in lower respiratory tract specimens (sputum, bronchoalveolar lavage, tracheal aspirate) (if positive at baseline)
Measured: within 14 days
Duration of oxygen therapy
Measured: within 28 days
Proportion of participants in each group with need for mechanical ventilation
Measured: within 28 days
Duration of hospitalization
Measured: within 28 days
All cause mortality
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study startMay 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: lack of public funding; planned control arm with Hydroxychloroquine treatment showed out as not being standard of care anymore as time evolved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluation of the efficacy and safety of hydroxychloroquine + camostat combination therapy in comparison to hydroxychloroquine + placebo in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Goethe University, St. Georg Hospital Leipzig, Germany, Hospital Schwabing Munich, Germany, Missioklinik, Wuerzburg, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338906
- Sponsor's protocol ID
- CLOCC-2020
- Acronym
- CLOCC
- Status last verified
- Dec 2020
- First submitted
- 3 Apr 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Camostat Mesilate + Hydroxychloroquine Combination Therapy in Hospitalized Patients With Moderate COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04338906
- Acronym / sponsor ID
- CLOCC / CLOCC-2020
- Conditions
- COVID
- Keywords
- Camostat, Hydroxychloroquine, Moderate COVID-10
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of public funding; planned control arm with Hydroxychloroquine treatment showed out as not being standard of care anymore as time evolved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Goethe University, St. Georg Hospital Leipzig, Germany, Hospital Schwabing Munich, Germany, Missioklinik, Wuerzburg, Germany
- Study start
- May 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 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.
Evaluation of the efficacy and safety of hydroxychloroquine - camostat combination therapy in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial Primary Objectives: The primary objective of this study is to demonstrate, that a combination therapy of hydroxychloroquine and camostat (Foipan®) is superior to hydroxychloroquine + placebo in participants with moderate COVID-19.
Detailed description
The ongoing pandemic with the novel coronavirus (SARS-CoV-2) poses a massive threat to public health. SARS-CoV-2 is highly contagious and may lead to severe acute respiratory distress syndrome in affected individuals. No therapeutic intervention has yet been approved for COVID-19, and initial interventional studies with single agents showed only minimal improvement in outcome or were not convincing in design. Therefore, the CLOCC trial will evaluate the efficacy and safety of a combination therapy consisting of hydroxychloroquine, which was used already as single agent with some effect, together with camostat mesylate in hospitalized patients with moderate COVID-19 infection. The rationale for this combination therapy stems from the observation that hydroxychloroquine interferes with viral entry and replication through several mechanisms including changes in endosomal pH and in glycosylation of the ACE2 receptor, which serves as entry receptor for SARS-CoV-2. Camostat acts as inhibitor of the host cell serine protease TMPRSS2, which is needed to prime the viral S protein for cell entry. Participants will be recruited in a total of 6 German centers, and the trial will be randomized (1:1) and enrolled in either the hydroxychloroquine + placebo or the hydroxychloroquine + camostat arm (7-day treatment). The trial will be carried out in a double-blinded fashion. The primary efficacy outcome is the number of patients discharged by day 14 (status 1 and 2 of a 7-point ordinal clinical status scale). Several secondary outcomes regarding efficacy but also safety will be evaluated. Exploratory endpoints include analysis of viral titers and the emergence of viral resistance in response to therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Evaluation of the efficacy and safety of hydroxychloroquine + camostat combination therapy in comparison to hydroxychloroquine + placebo in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial
| Arm | Type | Receives |
|---|---|---|
| Camostat + Hydroxychloroquine | Experimental | Drug: Camostat Mesilate, Drug: HydroxychloroquineSubjects will receive Camostat (400 mg tid) + hydroxychloroquine (400 mg bid day1, 200 mg bid d2-d7) |
| Placebo + Hydroxychloroquine | Active comparator | Drug: Placebo, Drug: HydroxychloroquineSubjects will receive placebo (tid) + hydroxychloroquine (400 mg bid day1, 200 mg bid d2-d7) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants ≥18 years of age with SARS-CoV-2 infection confirmed by PCR before randomization
- Willing and able to provide written informed consent
- Hospitalized and requiring medical care for COVID-19, (status 3 or 4 of 7-point ordinal clinical status scale)
- SpO2 ≥93% on room air
- Evidence of pulmonary infiltrate on chest X ray/and or CT scan
Key exclusion criteria (10 listed)
- Age <18 years old
- Pregnant or breast feeding
- Inability to take oral medication
- Inability to provide informed written consent
- Known hypersensitivity towards 4-aminoquinolines, e.g. hydroxychloroquine and/or camostat
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 Mesilate400 mg tid, d1-d7 | Drug | Camostat + Hydroxychloroquine |
| PlaceboInstead of Camostat Mesilate, tid, d1-d7 | Drug | Placebo + Hydroxychloroquine |
| Hydroxychloroquine400 mg bid on day 1, 200 mg bid d2-d7 | Drug | Camostat + Hydroxychloroquine, Placebo + Hydroxychloroquine |
Primary outcome
Not hospitalized
Time frame: day 14 from baseline
10 secondary outcomes
Time to improvement of 2 categories from admission on a 7-point ordinal scale
Time frame: day 14
Proportion of participants in each group with normalization of fever
Time frame: day 7 and day 14
Proportion of participants in each group with oxygen saturation > 94% on room air for >24h
Time frame: day 7 and day 14
Time to fever normalization (if febrile at baseline)
Time frame: within 14 days
Time to first negative SARS-CoV-2 PCR in NP swap (if pos. at baseline)
Time frame: within 14 days
Time to first negative SARS-CoV-2 PCR in lower respiratory tract specimens (sputum, bronchoalveolar lavage, tracheal aspirate) (if positive at baseline)
Time frame: within 14 days
Duration of oxygen therapy
Time frame: within 28 days
Proportion of participants in each group with need for mechanical ventilation
Time frame: within 28 days
Duration of hospitalization
Time frame: within 28 days
All cause mortality
Time frame: day 28
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 21 Dec 2020.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Camostat Mesilate and Hydroxychloroquine in people with COVID, run by Heinrich-Heine University, Duesseldorf.
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 5 inclusion and 10 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Not hospitalized (time frame: day 14 from baseline). 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 21 Dec 2020.