Trial NCT04353284
Publication Chupp G, medRxiv (2022) (preprint)
Dates: 2020-06-01 to 2021-04-30
Funding: Mixed (Kenneth C. Griffin; the Prostate Cancer Foundation; the COVID-19 Early Treatment Fund; the Harrington Discovery Institute; institutional funds from the Department of Internal Medicine at the Yale School of Medicine, and the Yale Center for Clinical Investigation; the United State Public Health Service; Ono Pharmaceuticals provided the study drug.)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / USA
Follow-up duration (days): 28
Inclusion criteria
  • 18 or older
  • a first positive COVID-19 RT-PCR assay within the 3 days before enrollment
  • at least one COVID-19-compatible symptom such as fever, upper respiratory symptoms, cough, chills, loss of taste/smell, or a recent high-risk exposure to COVID-19
Exclusion criteria
  • Hospitalized patients with Covid 19
  • pregnancy, lactation
  • an allergy to camostat mesylate
Interventions
Treatment
Camostat Mesilate
200 mg orally 4 times a day for 7 days
Control
Placebo

Participants
Randomized
participants :
Camostat Mesilate=35
Placebo=35
Characteristics of participants
N= 70
Mean age : NR
42 males
Severity : Mild: n= 70/ Asymptomatic: n=0
Number of vaccinated participants: 0
Primary outcome
In the register
Change in SARS-COV-2 viral load [ Time Frame: 5 days ] To determine whether camostat mesylate reduces SARS-COV-2 viral load in early COVID-19 disease, change from day 0 to day 4 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.
In the report
Change in the log10 viral load of a NP swab specimen as determined by quantitative RT-PCR testing from baseline to day 4 post-randomization.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Yes
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 pre-print article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary outcome in the article reflects that in the registry. The study (N = 70) did not achieve its target sample size (n = 114) because recruitment was terminated.
On October 20th, 2022, this study was updated with information extracted from registry. Of note, for the incidence of viral negative conversion outcome, results from both nasopharyngeal swab samples and saliva RT-PCR were reported; the latter was extracted.