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OpenTrials
Completed

NCT Number: NCT04470544

Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19

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.

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Key information

Conditions

Severe Acute Respiratory Syndrome Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Camostat Mesilate

Drug

Given PO

Other names: Foipan

Standard of care

Other

At Investigator discretion

Primary outcomes

  1. Proportion of Patients Alive and Free From Respiratory Failure

    Time frame: 28 Days

    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.

Secondary outcomes

  1. Proportion of Patients Alive and Free of Ventilator Use or ECMO

    Time frame: 28 Days

    To determine if reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with SOC treatment will change the proportion of patients alive and free of ventilator use or ECMO at Day 28 as compared to SOC treatment combined with placebo.

  2. Mortality Rate

    Time frame: 28 Days

    To determine if the combination of Camostat mesilate combined with SOC treatment will result in a changed mortality rate at 28 days as compared to SOC treatment combined with placebo.

  3. Clinical Change

    Time frame: 28 Days

    Clinical change will be defined as a 2 or more point decease on the WHO ordinal scale. The WHO ordinal scale ranges from 0, the best status, to 8, death. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change.

  4. Adverse Event Grade 3 Plus Rate

    Time frame: 28 days

    Analyses for safety will include all participants who are randomized and received at least 1 dose of study treatment. Participants will be grouped according to the treatment to which they were randomized.

Sponsors and collaborators

Lead sponsor

Alan Bryce

Other

Registry information

Official study title

RECOVER: Phase 2 Randomized, Double-Blind Trial TREating Hospitalized Patients With COVID-19 With Camostat MesilatE, a TMPRSS2 Inhibitor

Acronym: RECOVER

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 14, 2020
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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