Camostat Mesylate in COVID-19 Outpatients

NCT ID: NCT04353284

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-09
• Study Completion Date: 2021-04-22

Brief 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.

Detailed 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.

The primary objective of this study is to determine whether camostat mesylate reduces SARS-COV-2 viral load in early COVID-19 disease.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Camostat mesylate

Camostat mesylate 200mg taken 7 days.

Group Type: EXPERIMENTAL

Camostat Mesilate

Intervention Type: DRUG

Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.

Placebo

Placebo taken for 7 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo taken orally, 4 times daily, for 7 days.

Interventions

Camostat Mesilate

Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.

Intervention Type: DRUG

Placebo

Placebo taken orally, 4 times daily, for 7 days.

Intervention Type: OTHER

Other Intervention Names

Fiopan, Camostat Mesylate

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 ).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffrey Chupp, M.D.

Role: PRINCIPAL_INVESTIGATOR

Director, Yale Center for Asthma and Airways Disease (YCAAD)

Joseph Vinetz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Professor, Section of Infectious Diseases: Department of Internal Medicine

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

References

Kosinsky Y, Peskov K, Stanski DR, Wetmore D, Vinetz J. Semi-Mechanistic Pharmacokinetic-Pharmacodynamic Model of Camostat Mesylate-Predicted Efficacy against SARS-CoV-2 in COVID-19. Microbiol Spectr. 2022 Apr 27;10(2):e0216721. doi: 10.1128/spectrum.02167-21. Epub 2022 Apr 12.

Reference Type: DERIVED

PMID: 35412356 (View on PubMed)

Chupp G, Spichler-Moffarah A, Sogaard OS, Esserman D, Dziura J, Danzig L, Chaurasia R, Patra KP, Salovey A, Nunez A, May J, Astorino L, Patel A, Halene S, Wang J, Hui P, Patel P, Lu J, Li F, Gan G, Parziale S, Katsovich L, Desir GV, Vinetz JM. A Phase 2 Randomized, Double-Blind, Placebo-controlled Trial of Oral Camostat Mesylate for Early Treatment of COVID-19 Outpatients Showed Shorter Illness Course and Attenuation of Loss of Smell and Taste. medRxiv [Preprint]. 2022 Jan 31:2022.01.28.22270035. doi: 10.1101/2022.01.28.22270035.

Reference Type: DERIVED

PMID: 35132421 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2000027971

Identifier Type: -

Identifier Source: org_study_id