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Completed

NCT Number: NCT04524663

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Camostat Mesilate

Drug

Camostat Mesilate administered as oral tablets

Other names: Foipan®

Placebo

Drug

Placebo to match camostat mesilate

Standard of Care Treatment

Other

Standard of Care Treatment for COVID-19 Infection

Primary outcomes

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

    Time frame: Days 1-10

    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.

Secondary outcomes

  1. AUC of Shedding of SARS-CoV-2 Virus

    Time frame: Days 1-10, 14, 21, and 28

    AUC of shedding of SARS-CoV-2 virus calculated using the RT-PCR measures of viral load from self-collected nasal swabs on days 1-10, 14, 21, and 28. AUC was defined by a single participant's 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.

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

    Time frame: Up to 28 days

    This outcome is defined as the time in days from randomization to the first negative RT-PCR result of self-collected nasal swabs that is followed by only negative results (i.e. no later positive results are observed).

  3. Clinical Worsening of COVID-19 Disease in Symptomatic Patients

    Time frame: Up to 28 days

    Number of symptomatic patients with clinical worsening, defined as the development of respiratory distress or symptoms that require hospitalization.

  4. Time Until Resolution of Symptoms

    Time frame: Up to 28 days

    This outcome is defined as absence of moderate or severe symptoms for at least 24 hours for those reporting moderate or severe symptoms at baseline.

  5. Development of Antibodies to SARS-CoV-2

    Time frame: Up to 28 days

    Number of patients that develop antibodies to SARS-CoV-2.

  6. Drug Level on Day Five, One Hour After a Dose Taken on an Empty Stomach

    Time frame: Day 5, 1 hour post dose

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Camostat Mesilate Compared to Standard of Care in Subjects With Mild-Moderate COVID-19

Acronym: COPS-2003

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 24, 2020
Registry last updated
Jun 10, 2022

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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