Camostat mesylate in COVID-19 Outpatients
- Study HIC#:2000027971
- Last Updated:10/29/2020
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.
- Age18 years and older
- Start Date06/16/2020
- End Date05/30/2021
Trial Purpose and Description
The study is designed as a double-blind randomized controlled clinical trial to test the hypothesis that camostat mesylate, a serine protease inhibitor shown to inhibit SARS-COV-2 replication in vitro, inhibits SARS-COV-2 replication in early stage, laboratory-confirmed, COVID-19 ambulatory patients. Camostat mesylate, a serine protease inhibitor used primarily for treating postoperative reflux esophagitis and for acute exacerbations of chronic pancreatitis. This drug, with more than 15 years clinical experience in Japan with a very safe clinical track record, will be studied as a repurposed drug based on published in vitro virus inhibition data and in vivo protective effects in a mouse model of SARS.
- Present for enrollment within 2 days of being notified of their positive COVID-19 test result.
- 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 2 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.
- Presence of COVID-19 disease manifestations that would require referral for consideration of hospitalization.
- Pregnancy or lactation.
- Known allergic reactions to components of camostat mesylate.