Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients

NCT04524663 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 56029
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy of oral Foipan® (camostat mesilate) compared with the current standard of care in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with mild-moderate COVID-19 disease. Patients will attend 4 study visits over a period of up to 28 days.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of Shedding of SARS-CoV-2 Virus

  AUC of shedding of SARS-CoV-2 virus calculated using the reverse transcription-polymerase chain reaction (RT-PCR) measures of viral load from self-collected nasal swabs on days 1-10. AUC was defined by a single participant's cycle threshold (Ct) from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.

  Days 1-10

Secondary Outcomes (6)

• AUC of Shedding of SARS-CoV-2 Virus

  Days 1-10, 14, 21, and 28

• Time Until Cessation of Shedding of SARS-CoV-2 Virus

  Up to 28 days

• Clinical Worsening of COVID-19 Disease in Symptomatic Patients

  Up to 28 days

• Time Until Resolution of Symptoms

  Up to 28 days

• Development of Antibodies to SARS-CoV-2

  Up to 28 days

Study Arms (2)

Camostat mesilate

EXPERIMENTAL

Patients will receive camostat mesilate for 10 days in addition to standard of care treatment.

Drug: Camostat Mesilate; Other: Standard of Care Treatment

Placebo

PLACEBO COMPARATOR

Study participants will receive placebo to match camostat mesilate for 10 days in addition to standard of care treatment.

Drug: Placebo; Other: Standard of Care Treatment

Interventions

Camostat Mesilate DRUG

Camostat Mesilate administered as oral tablets

Also known as: Foipan®

Camostat mesilate

Placebo DRUG

Placebo to match camostat mesilate

Placebo

Standard of Care Treatment OTHER

Standard of Care Treatment for COVID-19 Infection

Camostat mesilate; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COVID-19 disease as presence of mild-moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours prior to informed consent
• Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
• Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
• Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy
• Females must have a negative pregnancy test at screening
• Participant agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol

You may not qualify if:

• Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study.
• Previous use of antiviral drugs that may be active against Covid-19.
• Abnormal laboratory test results at screening:
• Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.
• Serious chronic disease (e.g., human immunodeficiency virus \[HIV\], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
• Previously received camostat mesilate within the past 30 days.
• Advanced kidney disease
• Advanced liver disease
• History of alcohol or drug abuse in the previous 6 months.
• Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).
• Taken another investigational drug within the past 30 days.
• Seemed by the Investigator to be ineligible for any reason.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

camostat

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Julie Parsonnet, MD
• Organization: Stanford University

parsonnt@stanford.edu

(650) 725-4561

Study Officials

• Julie Parsonnet, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: August 24, 2020
• Study Start: December 19, 2020
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: June 10, 2022
• Results First Posted: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)