COV-AAT

Ghent University Hospital

Corneel Heymanslaan 10, Ghent, Belgium, 9000

HIRUZ, Ghent University Hospital, +32 93320500, sophie.degroote@uzgent.be

HIRUZ, Ghent University Hospital, 0477552757 93320500, sophie.degroote@uzgent.be

No

No

No

Final

12 Jul 2022

Yes

24 Jun 2021

Yes

24 Jun 2021

Yes

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. In this pilot we will assess efficacy of the drug in terms of viral load changes at D5 compared to baseline in nasopharyngeal (or nose/throat) swabs. Cycle threshold values will be used as a surrogate for viral load. Descriptive objectives are to assess the safety and compliance of the drug in ambulatory setting.

As a precautionary measure to reduce the risk of syncope, blood sampling was performed in a semi-suppine position. Subjects were followed-up through a home monitoring tool provided by Byteflies. The subject was asked to register heart rate, respiratory rate, temperature and oxygen saturation 3 times a day through an online platform (with back-up through email and phone). If these parameters were not within normal range as defined by cut-off criteria, the system asked either to remeasure or to contact the study-team based on the reported values. The physician checked these parameters daily, calling the patient herself if a parameter was out of normal range.

30 Nov 2020

No

Yes

Belgium: 108

108

108

0

0

0

0

0

0

101

7

0

Overall trial (overall period)

Randomised - controlled

The subject and all nursus/physicians that were in contact with the subject were blinded. To minimize the risk for unblinding: 2 co-workers were delegated as unblinded personnel at the clinic. 2 others were assigned as back-up for the 2 co-workers. Unblinded personnel and their study activities were documented on the delegation log. Unblinded personnel at the clinic did not have contact with subjects. Communication between unblinded and blinded personnel concerning allocation was traceable.

Yes

Camostat Mesilate

Foipan

Tablet

Oral use

Camostat Mesilate (Foipan) 100mg, 3 tablets, 3 times a day (daily dose of 900mg). After inclusion the patient will receive medication for 5 days of treatment (= 45 tablets). The patient will take the medication at home. Oral administration. Fasting state (minimum 60 minutes before the next meal and 2 hours after the previous meal). At D5, the patient will bring the empty bottle and leftover tablets to the consultation visit. If the treatment is extended to 10 days, the patient will receive medication at D5 for 5 days of treatment (= 45 tablets). He will take the medication at home and orally in a fasting state (minimum 60 minutes before the next meal and 2 hours after the previous meal). At D10, the patient will bring the empty bottle and leftover tablets to the consultation visit.

Placebo

Lactose

Tablet

Oral use

After inclusion the patient will receive medication for 5 days of treatment (= 45 tablets). The patient will take the medication at home. Oral administration. Fasting state (minimum 60 minutes before the next meal and minimum 2 hours after the previous meal). At D5, the patient will bring the empty bottle and leftover tablets to the consultation visit. If the treatment is extended to 10 days, the patient will receive medication at D5 for 5 days of treatment (= 45 tablets). He will take the medication at home and orally in a fasting state (minimum 60 minutes before the next meal and minimum 2 hours after the previous meal). At D10, the patient will bring the empty bottle and leftover tablets to the consultation visit.

Camostat Mesilate

Placebo

Per protocol analysis

A total of 96 participants received either camostat mesylate (N=66) or placebo (N=30). Treatment was immediately interrupted in 4 subjects that had to be hospitalized due to clinical deterioration. Two other subjects chose to withdraw from the study. Analyses were performed on the data of 90 participants who completed treatment (N=61 camostat mesylate, N=29 placebo).

Camostat Mesilate

Placebo

Per protocol analysis

A total of 96 participants received either camostat mesylate (N=66) or placebo (N=30). Treatment was immediately interrupted in 4 subjects that had to be hospitalized due to clinical deterioration. Two other subjects chose to withdraw from the study. Analyses were performed on the data of 90 participants who completed treatment (N=61 camostat mesylate, N=29 placebo).

to assess drug efficacy as change in the shedding of SARS-CoV-2 virus as measured by Ct obtained from nasopharyngeal swabs at day 1 and 5.

Primary

from day 1 to day 5

Change in Ct between day 1 and day 5 was compared using a linear mixed-effects model with random intercepts for participant. Estimates for change in Ct for camostat compared to placebo and corresponding 95% confidence intervals for the linear models were reported.

Camostat Mesilate v Placebo v Per protocol analysis

186

Pre-specified

1.183

2-sided

an improvement of the 5 most self-reported symptoms in at least 1 point from baseline on the 5-point Likert scale, which ever came first

Secondary

14 days

A Kaplan Meier curve was constructed for time to clinical improvement. Hazard ratios with 95% confidence intervals (CI) were estimated by Cox proportional-hazards model with and without adjustment for potential confounders. Patients were censored at time of last assessment or at end of trial. A two-sided α value of less than 0.05 was considered significant.

Camostat Mesilate v Placebo v Per protocol analysis

176

Pre-specified

from day 1 to day 28 visit

24.0

camostat mesylate group