NCT04470544

Brief Summary

To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

July 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

July 28, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

July 9, 2020

Results QC Date

February 29, 2024

Last Update Submit

October 21, 2024

Conditions

Severe Acute Respiratory Syndrome

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients Alive and Free From Respiratory Failure

    To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.

    28 Days

Secondary Outcomes (4)

  • Proportion of Patients Alive and Free of Ventilator Use or ECMO

    28 Days

  • Mortality Rate

    28 Days

  • Clinical Change

    28 Days

  • Adverse Event Grade 3 Plus Rate

    28 days

Study Arms (2)

Placebo + Standard of Care

PLACEBO COMPARATOR

Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.

Other: Standard of Care

Camostat + Standard of Care

EXPERIMENTAL

Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.

Drug: Camostat Mesilate

Interventions

Camostat MesilateDRUG

Given PO

Also known as: Foipan
Camostat + Standard of Care
Standard of CareOTHER

At Investigator discretion

Placebo + Standard of Care

Eligibility Criteria

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

You may qualify if:

  • Laboratory confirmed SARS-CoV-2 infection
  • Admitted to hospital for management of SARS-CoV-2
  • Age ≥18
  • Subject or legal representative able to give informed consent
  • Ability to take all study drugs
  • Respiratory status of 3 or greater on the WHO ordinal scale
  • ALT or AST ≤5 x ULN
  • Creatinine clearance ≥50 mL/min using the Cockroft-Gault formula
  • Willingness to provide mandatory specimens for correlative research and banking

You may not qualify if:

  • Women who are pregnant or breastfeeding
  • Known hypersensitivity to the study drug, the metabolites or formulation excipient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

camostatStandard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Alan Haruo Bryce, M.D.
Organization
Mayo Clinic
Bryce.Alan@mayo.edu
(480)301-8335

Study Officials

  • Alan H Bryce, M.D.

    Academic and Community Cancer Research United

    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 INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 14, 2020

Study Start

July 28, 2020

Primary Completion

December 22, 2021

Study Completion

January 20, 2022

Last Updated

November 12, 2024

Results First Posted

November 12, 2024

Record last verified: 2024-02

Locations

US(2)