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The Potential of Oral Camostat in Early COVID-19 Disease in an Ambulatory Setting to Reduce Viral Load and Disease Burden

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ClinicalTrials.gov Identifier: NCT04625114
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief 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 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.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Camostat Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double blinded placebo controlled
Primary Purpose: Treatment
Official Title: The Potential of Oral Camostat in Early COVID-19 Disease in an Ambulatory Setting to Reduce Viral Load and Disease Burden
Actual Study Start Date : November 4, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : January 1, 2023

Arm Intervention/treatment
Experimental: Camostat
camostat 100mg 3 tablets 3x/day D1->D5 (+ possible extension D6->D10)
Drug: Camostat
Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1->D5);

Drug: Camostat
Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6->D10);

Placebo Comparator: Placebo
Placebo 3 tablets 3x/day D1->D5 (+ possible extension D6->D10)
Drug: Placebo
SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1->D5).

Drug: Placebo
SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6->D10).




Primary Outcome Measures :
  1. Efficacy in terms of viral load or surrogate [ 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) log10 viral load.

    Surrogate market CT value will be used as well.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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
  • 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.

Exclusion Criteria

  • 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.
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625114


Contacts
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Contact: Marie-Angélique De Scheerder +32476937613 marie-angelique.descheerder@uzgent.com

Locations
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Belgium
Ghent University Hospital, Algemene Inwendige Ziekten Recruiting
Gent, Belgium, 9000
Contact: Marie-Angélique De Scheerder    0476937613    marie-angelique.descheerder@uzgent.com   
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Linos Vandekerckhove UZ Gent
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT04625114    
Other Study ID Numbers: EudraCT number: 2020-003475-18
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
antiviral
Additional relevant MeSH terms:
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Gabexate
Camostat
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors
Anticoagulants