Covid-19 Living Data

Trial NCT04583592
Publication CAMELOT - Jilg N, Top Antivir Med (2022) (results posted on registry)

Funding: Not reported/unclear
Conflict of interest: *

Methods
	RCT Blinding: quadruple blinding
	Location : Multicenter / USA Follow-up duration (days): 28
Inclusion criteria	Adults willing and able to provide informed consent before performing study procedures Adults ≥18 years of age at time of informed consent Participants must have written notification of laboratory confirmed COVID-19 infection performed prior to screening, at a local laboratory by RT-PCR or other commercial or public health assay in any specimen and participants must be randomized within 72 hours of receiving the above notification of laboratory confirmed COVID-19 Have a mild or moderate form of COVID-19 defined as SpO2 > 94% at screening Participants must have at least 1 of the following risk factors for severe illness Aged 65 years or older, Hypertension, Diabetes mellitus, Chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (eg, idiopathic pulmonary fibrosis) Chronic cardiac conditions, including coronary artery disease (CAD), heart failure, congenital heart disease, cardiomyopathy, Severe obesity (body mass index [BMI] ≥ 40 kg/m^2), Chronic liver disease, including cirrhosis Must agree not to enroll in another study of an investigational agent or take any other drug that has been granted Emergency Use Authorization prior to completion of Day 28 If women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for 90 days after receiving the last dose of study drug
Exclusion criteria	Physician makes a decision that trial involvement is not in participants' best interest, or has any condition that does not allow the protocol to be followed safely Known severe liver disease (eg, Child Pugh score > 12, AST >5 times upper limit) SaO2/SPO2 ≤94% on room air condition, or the Pa02/Fi02 ratio < 300 mgHg Known allergic reaction to camostat mesilate or one of its excipients Known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m^2) or receiving dialysis Pregnant or breastfeeding, or positive pregnancy test in a predose examination Receipt of any experimental treatment for COVID-19, including agents with demonstrated or possible direct acting antiviral activity, including, but not limited to, remdesivir, hydroxychloroquine, lopinavir/ritonavir, tocilizumab, or ivermectin, within the 30 days prior to the time of the screening evaluation. No off label use of a drug for COVID 19 is allowed History of human immunodeficiency virus infection on highly active antiretroviral therapy (HAART)
Interventions
	Treatment Camostat Mesilate 200 mg orally 4 times a day for 14 days
	Control Placebo
Participants
	Randomized participants : Placebo=101 Camostat Mesilate=194
	Characteristics of participants N= 295 Mean age : NR 126 males Severity : Mild: n= 295/ Asymptomatic: n=* Number of vaccinated participants: NR
Primary outcome
	In the register Disease Progression at Day 28 [ Time Frame: 28 days ] Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization.
	In the report Hospitalization or death within 28 days
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	Low
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. The trial (n=295) achieved its target sample size (n=300). This study was updated on January 26th, 2023 with data extracted from the published abstract.