Clinical trial NCT04524663: Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Curve (AUC) of Shedding of SARS-CoV-2 Virus
timeFrame: Days 1-10
Secondary outcomes:
measure: AUC of Shedding of SARS-CoV-2 Virus
timeFrame: Days 1-10, 14, 21, and 28
measure: Time Until Cessation of Shedding of SARS-CoV-2 Virus
timeFrame: Up to 28 days
measure: Clinical Worsening of COVID-19 Disease in Symptomatic Patients
timeFrame: Up to 28 days
measure: Time Until Resolution of Symptoms
timeFrame: Up to 28 days
measure: Development of Antibodies to SARS-CoV-2
timeFrame: Up to 28 days
measure: Drug Level on Day Five, One Hour After a Dose Taken on an Empty Stomach
timeFrame: Day 5, 1 hour post dose
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Julie Parsonnet, MD
role: PRINCIPAL_INVESTIGATOR
References: