The Potential of Camostat in COVID-19

NCT04625114 | Terminated Phase 2 Results DMC

• 1 other identifier: BC-7707
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

antiviral

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  28 days

• Neutralizing Antibodies (NAbs) at Visit 28

  28 days

Study Arms (2)

Camostat

EXPERIMENTAL

camostat 100mg 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10)

Drug: Camostat

Placebo

PLACEBO COMPARATOR

Placebo 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10)

Drug: Placebo

Interventions

Camostat DRUG

Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1-\>D5);

Camostat

Placebo DRUG

SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1-\>D5).

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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).

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital, Algemene Inwendige Ziekten

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35803469 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

camostat

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr Marie-Angélique De Scheerder
• Organization: University Hospital Ghent

marie-angelique.descheerder@uzgent.be

+32 9 33 21349

Study Officials

• Steven Callens

  UZ Gent

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blinded placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: November 4, 2020
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)