Trial NCT04625114
Publication Tobback E, Int J Infect Dis (2022) (published paper)
Dates: 2020-11-04 to 2021-06-30
Funding: Mixed (Ono Pharmaceuticals Co. Ltd. (Osaka, Japan) provided the study drug, camostat mesylate. Byteflies (Antwerp, Belgium) provided telemonitoring devices and technological support. No further funding was received.)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / Belgium
Follow-up duration (days): 28
Inclusion criteria
  • Symptomatic (maximum 5 days) and asymptomatic patients
  • confirmed COVID-19 infection by a reverse transcription-polymerase chain reaction (RT-PCR)
  • 18 years or older
  • willing to follow the study interventions, and capable of understanding and signing the informed consent form
  • Women of childbearing potential or men of reproductive potential had to be willing to use contraception during and until the end of the study.
Exclusion criteria
  • The need for or being at high risk of hospitalization
  • pregnancy as checked by a urine pregnancy test at baseline or breastfeeding
  • severe chronic pancreatitis
  • postoperative reflux esophagitis.
Interventions
Treatment
Camostat Mesilate
300 mg orally three times a day for 5 days, with possible extension to 10 days
Control
Placebo

Participants
Randomized
participants :
Camostat Mesilate=66
Placebo=30
Characteristics of participants
N= 96
Mean age : NR
41 males
Severity : Mild: n= 77/ Asymptomatic: n=13
Number of vaccinated participants: 5
Primary outcome
In the register
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.
In the report
Change in the shedding of the SARS-CoV-2 virus as measured by Ct obtained from nasopharyngeal swabs on days 1 and 5.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcome in the article reflects that in the registry. The trial did not achieve its target sample size due to a lack of available enrollees and the per protocol decision was taken to conduct this interim analysis, after which recruitment was stopped.