Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Camostat Mesilate; Placebo
Intervention description: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.; Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Intervention MeSH terms: Gabexate; Camostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled study of camostat mesilate in
      ambulatory patients with confirmed COVID-19 with at least one risk factor for severe illness.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults willing and able to provide informed consent before performing study procedures

          2. Adults ≥18 years of age at time of informed consent

          3. 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

          4. Have a mild or moderate form of COVID-19 defined as SpO2 > 94% at screening

          5. Participants must have at least 1 of the following risk factors for severe illness

               1. Aged 65 years or older

               2. Hypertension

               3. Diabetes mellitus

               4. Chronic lung disease including asthma, chronic obstructive pulmonary disease
                  (COPD), and interstitial lung disease (eg, idiopathic pulmonary fibrosis)

               5. Chronic cardiac conditions, including coronary artery disease (CAD), heart
                  failure, congenital heart disease, cardiomyopathy

               6. Severe obesity (body mass index [BMI] ≥ 40 kg/m^2)

               7. Chronic liver disease, including cirrhosis

          6. 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

          7. 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:

          1. 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

          2. Known severe liver disease (eg, Child Pugh score > 12, AST >5 times upper limit)

          3. SaO2/SPO2 ≤94% on room air condition, or the Pa02/Fi02 ratio < 300 mgHg

          4. Known allergic reaction to camostat mesilate or one of its excipients

          5. Known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73
             m^2) or receiving dialysis

          6. Pregnant or breastfeeding, or positive pregnancy test in a predose examination

          7. 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.

          8. History of human immunodeficiency virus infection on highly active antiretroviral
             therapy (HAART)