This is a randomized, double-blind, placebo-controlled study of camostat mesilate in ambulatory patients with confirmed COVID-19 with at least one risk factor for severe illness.
Participants will be randomized in a 2:1 ratio of camostat:placebo. Approximately 300 participants are planned to be enrolled (200 participants to camostat mesilate and 100 participants to placebo). Participants will be treated with camostat mesilate 200 mg or placebo drug orally 4 times a day for 14 days, and receive local standard of care (SOC) in addition to study drug. Participants will be followed until Day 28. Participants will be seen in the clinic for assessments, blood draws, and mid-turbinate nasal samples on Screening/Day 1, Day 7, Day 15 and early termination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
295
Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Palmtree Clinical Research, Inc. (Site 125)
Palm Springs, California, United States
Disease Progression at Day 28
Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization.
Time frame: 28 days
Survival Rate
The overall survival rate (the number of randomized participants who survive up to Day 15 and Day 28).
Time frame: Up to Day 15 and Day 28
Time to Fever Resolution
Time (in days) from initiation of study treatment until normalization of fever (≤ 37.2 °C oral or tympanic) and sustained for at least 3 days only assessed in participants who experienced a fever within 1 day of enrollment up to Day 28.
Time frame: Up to 28 days
Resolution of Viral Shedding
Number of participants with no viral shedding (yes/no) using reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 7, Day 15, and at early termination.
Time frame: Day 1, Day 7 and Day 15
Rate of Adverse Events and Serious Adverse Events
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs) of any grade from randomization up to Day 28.
Time frame: 28 days
Cumulative Rate of Grade 3 and 4 Adverse Events
Cumulative number of participants with grade 3 and 4 AEs from randomization up to Day 28.
Time frame: 28 days
Rate of Discontinuation
Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28).
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Synergy Healthcare, LLC (Site 124)
Bradenton, Florida, United States
Clinical Research of Brandon, LLC (Site 123)
Brandon, Florida, United States
Reliable Clinical Research, LLC (Site 100)
Hialeah, Florida, United States
A+ Research (Site 112)
Miami, Florida, United States
NextPhase Research Alliance at CANO HEALTH (Site 107)
Miami, Florida, United States
Ezy Medical Research (Site 106)
Miami, Florida, United States
Eminat LLC (Site 117)
Plantation, Florida, United States
Invictus Clinical Research Group, LLC (Site 101)
Pompano Beach, Florida, United States
Visionaries Clinical Research, LLC (Site 121)
Atlanta, Georgia, United States
...and 11 more locations
Time frame: 28 days
Laboratory Parameter - Platelet Count
Clinical Laboratory Value of Platelet Count at Day 1 and Day 15
Time frame: Day 1 and Day 15
Laboratory Parameter - Potassium Level
Clinical laboratory value of Potassium Levels at Day 1 and Day 15
Time frame: Day 1 and Day 15
Laboratory Parameter - Aspartate Aminotransferase (AST)
Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15
Time frame: Day 1 and Day 15
Laboratory Parameter - Alanine Aminotransferase (ALT)
Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15
Time frame: Day 1 and Day 15
Laboratory Parameter - Alkaline Phosphatase (ALP)
Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15
Time frame: Day 1 and Day 15
Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)
Clinical laboratory value of Gamma-Glutamyl Transferase (GGT) at Day 1 and Day 15
Time frame: Day 1 and Day 15
Vital Signs - Heart Rate
Heart rate at Day 1, Day 7 and Day 15
Time frame: Day 1, Day 7 and Day 15
Vital Signs - Blood Pressure
Blood pressure (BP) at Day 1, Day 7 and Day 15
Time frame: Day 1, Day 7 and Day 15
Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)
Peripheral Capillary Oxygen Saturation (SpO2) at Day 1, Day 7 and Day 15
Time frame: Day 1, Day 7 and Day 15