The Potential of Camostat in COVID-19
- Registration Number
- NCT04625114
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Camostat Camostat camostat 100mg 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10)
- Primary Outcome Measures
Name Time Method Efficacy in Terms of Viral Load or Surrogate After 5 Days of Treatment 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Neutralizing Antibodies (NAbs) at Visit 28 28 days The 50% neutralizing antibody titer (NT50) was compared between the camostat and placebo group
Trial Locations
- Locations (1)
Ghent University Hospital, Algemene Inwendige Ziekten
🇧🇪Gent, Belgium