Camostat Mesylate in COVID-19 Outpatients
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Camostat Mesilate; Placebo
Intervention description: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.; Placebo taken orally, 4 times daily, for 7 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: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The rationale of the present clinical trial is that an orally available drug given to
      outpatients that could reduce the viral burden in the upper respiratory tract could forestall
      complications of SARS-CoV-2 infection and reduce transmission from one infected individual to
      another.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be enrolled within 3 days of being notified of their first positive COVID-19 test
             result.

          -  Evidence of a recent active COVID-19 infection, as evidenced by the positive test
             results being associated with at least one COVID-19-compatible symptom such as fever,
             upper respiratory symptoms, cough, chills, loss of taste/smell, etc.(see COVID-19-PRO
             symptom score sheet), or a recent high-risk exposure to COVID-19

          -  Provision of informed consent.

          -  Stated willingness to comply with all study procedures and availability for the
             duration of the study.

          -  Diagnosed with COVID-19 within past 3 days and not exhibiting manifestations requiring
             hospitalization such as extreme shortness of breath or severe prostration. Nurses at
             the study site will assess such severe conditions requiring hospitalization, which
             would preclude enrollment.

          -  Ability to take oral medication and be willing to adhere to the camostat mesylate
             regimen.

          -  For females of reproductive potential: use of highly effective contraception for at
             least 1 month prior to screening and agreement to use such a method during study
             participation and for an additional 4 weeks after the end of the camostat mesylate
             administration.

          -  For males of reproductive potential: use of condoms or other methods to ensure
             effective contraception with partner.

          -  Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study
             duration.

          -  English and Spanish speaking subjects as well as patients speaking any language for
             which we can find appropriate translators will be enrolled. A short form with
             interpretation will be used for anyone speaking a language for which a translated
             informed consent form is not currently available in accordance with local site IRB
             policies, including developing certified translations as necessary.

        Exclusion Criteria:

          -  Presence of COVID-19 disease manifestations that would require referral for
             consideration of hospitalization.

          -  A previous positive COVID-19 test reported more than 7 days before, which would
             indicate likelihood of non-culturable, nonreplicating virus.

          -  A positive COVID-19 test without a known recent exposure that would indicate an active
             infection, hence an unknown chance of non-culturable, non-replicating virus being
             present (i.e., asymptomatic COVID-19 infection of unknown duration).

          -  Pregnancy or lactation.

          -  Known allergic reactions to components of camostat mesylate.

          -  With regard to inclusion or exclusion of women of child-bearing potential, women who
             report that they know they are pregnant are excluded. All women of child-bearing
             potential who test positive for pregnancy by urine test at first visit are excluded. A
             day 14 followup blood pregnancy test will be done on appropriate enrolled women (i.e.
             those who had a negative urine pregnancy test on day 0 for further safety assessment
             ).