Covid19Phase 2COV-AATNCT04625114
The Potential of Camostat in COVID-19
A Phase 2 study testing Camostat in people with Covid19, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The investigators are conducting a pilot trial where they will study safety, efficacy and compliance in a cohort of ambulatory patients in the Ghent region with confirmed COVID-19 infection, in both an early stage of disease, defined as less than 5 days of symptoms and who at presentation do not meet any criteria for… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19
- What is being tested?
- Camostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Nov 2020to 12 Jul 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18
- Willing to participate and fill out a daily symptom diary
- Willing to take the parameters such as blood oxygenation and temperature
- Willing to attend follow-up visits both by phone as at the clinic
- Capable of understanding the commitment in the trial
- Signed informed consent
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- Signs and symptoms suggestive of COVID disease in absence of hospitalization criteria as defined by the flowchart used at the emergency department of our institution (appendix 4), present for maximum 5 days and confirmed by PCR.
- OR documented COVID-19 infection by PCR with CT value below the threshold of 30 in asymptomatic individuals.
- For women of childbearing potential*: they should be willing to use highly effective method of contraception during treatment and until the end of study defined as having a failure rate of less than 1% per year when used consistently and correctly.
- Such methods include:
- combined (estrogen and progestogen containing) hormonal contraception
- associated with inhibition of ovulation: oral, intravaginal or transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable
- intrauterine device (IUD) and intrauterine hormone-releasing system ( IUS)
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence
- For men of reproductive potential**: condom should be used as contraception during treatment and until the end of study when having a partner of childbearing potential
- a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
Who cannot join
- Inability to make a decision to participate
- Pregnant or breast feeding
- Inability to take oral medication
- Inability to provide informed written consent
- Known hypersensitivity towards Camostat or other Serine protease inhibitors
- Any condition that, in the Investigator's opinion, prevents adequate compliance with study therapy.
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- Any COVID infection at risk for hospitalisation as described in the emergency department flowchart (cfr appendix 4)
- With regard to exclusion of women of child-bearing potential, women who tell us they know they are pregnant are excluded. All women of child-bearing potential who test positive for pregnancy by urine test at first visit are excluded.
- Severe chronic pancreatitis requiring suction of gastric juice, fasting or abstention from drinking
- Postoperative reflux oesophagitis due to reflux or gastric juice
- Postoperative reflux oesophagitis (if improvement of symptoms is not observed).
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ghent University Hospital, Algemene Inwendige Ziekten
Ghent, 9000
About this study
Official title: The Potential of Oral Camostat in Early COVID-19 Disease in an Ambulatory Setting to Reduce Viral Load and Disease Burden
The investigators are conducting a pilot trial where they will study safety, efficacy and compliance in a cohort of ambulatory patients in the Ghent region with confirmed COVID-19 infection, in both an early stage of disease, defined as less than 5 days of symptoms and who at presentation do not meet any criteria for hospitalisation as well as asymptomatic individuals with a PCR CT value below 30.
The primary endpoint is to assess the efficacy of the drug in terms of change from day 0 to day 5 in respiratory (oropharyngeal swab RT-PCR) log10 viral load.
The aim of the study is to assess whether Camostat, a serine protease inhibitor available in an oral formulation has the potential to be studied as an antiviral drug in a large scale ambulatory setting to prevent transmission by decreasing viral load, to prevent symptoms after exposure (PEP) in asymptomatic individuals or to prevent disease progression in the occurrence of early symptomatology.
Read the detailed description
Core study After eligibility assessment participants will be randomized and will receive the study drugs. We will define D1 as the first dose of the medication which can be the morning, midday or evening dose. They will be treated for 5 consecutive days.
In patients with a positive PCR at D5 (CT value with threshold below 30) and/or presence of clinical symptoms after exclusion of hospitalization criteria (flowchart emergency department appendix 4), the treatment will be extended up to D10 at the same dosage in both treatment arms for 5 consecutive days: D6 and D10).
Follow-up will be as follows:
- D1->D14 (D28): The study participants will be asked to fill in daily questionnaires assessing symptoms (cfr daily self-score). They will receive a kit enabling to monitor heart rate (HR), respiratory rate (RR), temperature and oxygen saturation 3 times per day (every 4-8 hours, preferentially at the timing of medication intake at D1 to D5 or D10).
- Compliance and tolerance will be assessed during the treatment period, D0->D5 (or D0->D10 if the treatment is prolonged).
- During the study D1-D28: If indicated in the opinion of the investigator, a physical exam and biochemistry will be performed through a consultation at the clinic. This can be requested at any time during the study based on clinical symptoms or signs.
- Consultation at D0, D5, (D10) and D28 at our COVID consultation facility. This will be done by a study nurse and/or a study physician.
- Conditions
- Covid19
- Being tested
- Camostat, Placebo
- Keywords
- antiviral
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamostatDrug
Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1->D5);
PlaceboDrug
SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1->D5).
CamostatDrug
Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6->D10);
PlaceboDrug
SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6->D10).
| Study group | Role | What they receive |
|---|---|---|
| Camostat | Experimental | camostat 100mg 3 tablets 3x/day D1->D5 (+ possible extension D6->D10) Receives: Drug: Camostat |
| Placebo | Placebo comparator | Placebo 3 tablets 3x/day D1->D5 (+ possible extension D6->D10) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in Terms of Viral Load or Surrogate After 5 Days of Treatment
The primary endpoint is to assess the efficacy of the drug in terms of change from day 0 to day 5 in respiratory (oropharyngeal swab RT-PCR) surrogate market CT value. Higher values equate to better outcomes.
Measured: 5 days
Secondary outcomes (2)
Number of Patients With Clinical Improvement (in at Least 1 Point on the 5-point Likert Scale) of 5 Most Self-reported Symptoms
Symptoms were daily measured by means of a self-report questionnaire. The top 5 self-reported symptoms during the whole study period were determined. Time to clinical improvement of these 5 most self-reported symptoms were compared between the camostat and placebo group. Additionally, potential risk factors are studied in order to influence clinical improvement.
Measured: 28 days
Neutralizing Antibodies (NAbs) at Visit 28
The 50% neutralizing antibody titer (NT50) was compared between the camostat and placebo group
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 posted12 Nov 2020
- Study start4 Nov 2020
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Why it stopped: Interim analyses did not show evidence that camostat mesylate under the present conditions (300 mg three times daily for five or 10 consecutive days, fasted state) was effective as an antiviral drug against early phase SARS-CoV-2 disease.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Callens, Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625114
- Sponsor's protocol ID
- BC-7707
- Acronym
- COV-AAT
- Status last verified
- Aug 2024
- First submitted
- 5 Nov 2020
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tobback E, Degroote S, Buysse S, Delesie L, Van Dooren L, Vanherrewege S, Barbezange C, Hutse V, Romano M, Thomas I, Padalko E, Callens S, De Scheerder MA. Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial. Int J Infect Dis. 2022 Sep;122:628-635. doi: 10.1016/j.ijid.2022.06.054. Epub 2022 Jul 5.
PubMed 35803469
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Oral Camostat in Early COVID-19 Disease in an Ambulatory Setting to Reduce Viral Load and Disease Burden
- ClinicalTrials.gov ID
- NCT04625114
- Acronym / sponsor ID
- COV-AAT / BC-7707
- Conditions
- Covid19
- Keywords
- antiviral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analyses did not show evidence that camostat mesylate under the present conditions (300 mg three times daily for five or 10 consecutive days, fasted state) was effective as an antiviral drug against early phase SARS-CoV-2 disease.
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are conducting a pilot trial where they will study safety, efficacy and compliance in a cohort of ambulatory patients in the Ghent region with confirmed COVID-19 infection, in both an early stage of disease, defined as less than 5 days of symptoms and who at presentation do not meet any criteria for hospitalisation as well as asymptomatic individuals with a PCR CT value below 30.
The primary endpoint is to assess the efficacy of the drug in terms of change from day 0 to day 5 in respiratory (oropharyngeal swab RT-PCR) log10 viral load.
The aim of the study is to assess whether Camostat, a serine protease inhibitor available in an oral formulation has the potential to be studied as an antiviral drug in a large scale ambulatory setting to prevent transmission by decreasing viral load, to prevent symptoms after exposure (PEP) in asymptomatic individuals or to prevent disease progression in the occurrence of early symptomatology.
Detailed description
Core study After eligibility assessment participants will be randomized and will receive the study drugs. We will define D1 as the first dose of the medication which can be the morning, midday or evening dose. They will be treated for 5 consecutive days.
In patients with a positive PCR at D5 (CT value with threshold below 30) and/or presence of clinical symptoms after exclusion of hospitalization criteria (flowchart emergency department appendix 4), the treatment will be extended up to D10 at the same dosage in both treatment arms for 5 consecutive days: D6 and D10).
Follow-up will be as follows:
- D1->D14 (D28): The study participants will be asked to fill in daily questionnaires assessing symptoms (cfr daily self-score). They will receive a kit enabling to monitor heart rate (HR), respiratory rate (RR), temperature and oxygen saturation 3 times per day (every 4-8 hours, preferentially at the timing of medication intake at D1 to D5 or D10).
- Compliance and tolerance will be assessed during the treatment period, D0->D5 (or D0->D10 if the treatment is prolonged).
- During the study D1-D28: If indicated in the opinion of the investigator, a physical exam and biochemistry will be performed through a consultation at the clinic. This can be requested at any time during the study based on clinical symptoms or signs.
- Consultation at D0, D5, (D10) and D28 at our COVID consultation facility. This will be done by a study nurse and/or a study physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camostat | Experimental | Drug: Camostatcamostat 100mg 3 tablets 3x/day D1->D5 (+ possible extension D6->D10) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 3 tablets 3x/day D1->D5 (+ possible extension D6->D10) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Aged ≥18
- Willing to participate and fill out a daily symptom diary
- Willing to take the parameters such as blood oxygenation and temperature
- Willing to attend follow-up visits both by phone as at the clinic
- Capable of understanding the commitment in the trial
Key exclusion criteria (11 listed)
- Inability to make a decision to participate
- Pregnant or breast feeding
- Inability to take oral medication
- Inability to provide informed written consent
- Known hypersensitivity towards Camostat or other Serine protease inhibitors
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 |
|---|---|---|
| CamostatStandard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1->D5); | Drug | Camostat |
| PlaceboSOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1->D5). | Drug | Placebo |
| CamostatStandard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6->D10); | Drug | Camostat |
| PlaceboSOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6->D10). | Drug | Placebo |
Primary outcome
Efficacy in Terms of Viral Load or Surrogate After 5 Days of Treatment
Time frame: 5 days
The primary endpoint is to assess the efficacy of the drug in terms of change from day 0 to day 5 in respiratory (oropharyngeal swab RT-PCR) surrogate market CT value. Higher values equate to better outcomes.
2 secondary outcomes
Number of Patients With Clinical Improvement (in at Least 1 Point on the 5-point Likert Scale) of 5 Most Self-reported Symptoms
Time frame: 28 days
Neutralizing Antibodies (NAbs) at Visit 28
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 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35803469Tobback E, Degroote S, Buysse S, Delesie L, Van Dooren L, Vanherrewege S, Barbezange C, Hutse V, Romano M, Thomas I, Padalko E, Callens S, De Scheerder MA. Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial. Int J Infect Dis. 2022 Sep;122:628-635. doi: 10.1016/j.ijid.2022.06.054. Epub 2022 Jul 5.
- 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.
Steven Callens principal investigator
UZ Gent
1 site 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 in people with Covid19, run by University Hospital, Ghent at 1 site in Belgium.
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 20 inclusion and 11 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 9 Aug 2024. 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 Belgium. 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 9 Aug 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?
Efficacy in Terms of Viral Load or Surrogate After 5 Days of Treatment (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04625114, which also lists 1 linked publication.
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 9 Aug 2024.