Covid-19 Living Data

Trial NCT04524663
Publication COPS-2003 - NCT04524663, Unpublished (2022) (results posted on registry)

Funding: Not reported/unclear
Conflict of interest: *

Methods
	RCT Blinding: double blinding
	Location : Single center / USA Follow-up duration (days): 28
Inclusion criteria	Diagnosis of COVID-19 disease as presence of mild-moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours prior to informed consent Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy Females must have a negative pregnancy test at screening Participant agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol
Exclusion criteria	Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study Previous use of antiviral drugs that may be active against Covid-19 Abnormal laboratory test results at screening Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19 Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency) Previously received camostat mesilate within the past 30 days Advanced kidney disease Advanced liver disease History of alcohol or drug abuse in the previous 6 months Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year) Taken another investigational drug within the past 30 days Seemed by the Investigator to be ineligible for any reason
Interventions
	Treatment Camostat Mesilate 200 mg orally 4 times per day for 10 days
	Control Placebo
Participants
	Randomized participants : Camostat Mesilate=25 Placebo=24
	Characteristics of participants N= 49 Mean age : NR 32 males Severity : Mild: n= 49/ Asymptomatic: n=* Number of vaccinated participants: NR
Primary outcome
	In the register Area Under the Curve (AUC) of Shedding of SARS-CoV-2 Virus [ Time Frame: Days 1-10 ]
	In the report NR
Documents available	Protocol Yes. In English Statistical plan Yes 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	This is an unpublished trial whose results have been reported in ClinicalTrials.gov. The trial registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. The trial was registered prospectively and no important changes were made to primary or secondary outcomes after recruitment start.