NCT04353284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_2 covid19

Timeline
Completed

Started Jun 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 9, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2021

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 24, 2022

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

April 16, 2020

Results QC Date

March 2, 2022

Last Update Submit

March 22, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Change in SARS-COV-2 Viral Load

    To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 4 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.

    5 days (day 0 to day 4)

Secondary Outcomes (11)

  • Change in SARS-COV-2 Viral Load

    3 days (day 0 to day 2)

  • Change in SARS-COV-2 Viral Load

    7 days (day 0 to day 6)

  • Number of Participants With Change in Positive COVID-19 Status

    7 days

  • Number of Participants With Change in Positive COVID-19 Status

    14 days

  • Change in Positive COVID-19 Status

    28 days

  • +6 more secondary outcomes

Study Arms (2)

Camostat mesylate

EXPERIMENTAL

Camostat mesylate 200mg taken 7 days.

Drug: Camostat Mesilate

Placebo

PLACEBO COMPARATOR

Placebo taken for 7 days.

Other: Placebo

Interventions

Camostat MesilateDRUG

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

Also known as: Fiopan, Camostat Mesylate
Camostat mesylate
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (2)

  • 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.

    PMID: 35412356DERIVED

  • 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.

    PMID: 35132421DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

camostat

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Geoffrey Chupp, MD Professor of Medicine (Pulmonary); Director, Yale Center for Asthma and Airways D
Organization
Yale School of Medicine
geoffrey.chupp@yale.edu
(203) 785-3627

Study Officials

  • Geoffrey Chupp, M.D.

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

    PRINCIPAL INVESTIGATOR

  • Joseph Vinetz, M.D.

    Professor, Section of Infectious Diseases: Department of Internal Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 20, 2020

Study Start

June 9, 2020

Primary Completion

March 3, 2021

Study Completion

April 22, 2021

Last Updated

March 24, 2022

Results First Posted

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)