Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)

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)