Clinical trial NCT04583592: Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Sagent Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-12
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Adults willing and able to provide informed consent before performing study procedures
2. Adults ≥18 years of age at time of informed consent
3. Participants must have written notification of laboratory confirmed COVID-19 infection performed prior to screening, at a local laboratory by RT-PCR or other commercial or public health assay in any specimen; and participants must be randomized within 72 hours of receiving the above notification of laboratory confirmed COVID-19
4. Have a mild or moderate form of COVID-19 defined as SpO2 \> 94% at screening
5. Participants must have at least 1 of the following risk factors for severe illness

   1. Aged 65 years or older
   2. Hypertension
   3. Diabetes mellitus
   4. Chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (eg, idiopathic pulmonary fibrosis)
   5. Chronic cardiac conditions, including coronary artery disease (CAD), heart failure, congenital heart disease, cardiomyopathy
   6. Severe obesity (body mass index \[BMI\] ≥ 40 kg/m\^2)
   7. Chronic liver disease, including cirrhosis
6. Must agree not to enroll in another study of an investigational agent or take any other drug that has been granted Emergency Use Authorization prior to completion of Day 28
7. If women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for 90 days after receiving the last dose of study drug

Exclusion Criteria:

1. Physician makes a decision that trial involvement is not in participants' best interest, or has any condition that does not allow the protocol to be followed safely
2. Known severe liver disease (eg, Child Pugh score \> 12, AST \>5 times upper limit)
3. SaO2/SPO2 ≤94% on room air condition, or the Pa02/Fi02 ratio \< 300 mgHg
4. Known allergic reaction to camostat mesilate or one of its excipients
5. Known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m\^2) or receiving dialysis
6. Pregnant or breastfeeding, or positive pregnancy test in a predose examination
7. Receipt of any experimental treatment for COVID-19, including agents with demonstrated or possible direct acting antiviral activity, including, but not limited to, remdesivir, hydroxychloroquine, lopinavir/ritonavir, tocilizumab, or ivermectin, within the 30 days prior to the time of the screening evaluation. No off label use of a drug for COVID 19 is allowed.
8. History of human immunodeficiency virus infection on highly active antiretroviral therapy (HAART)

Primary outcomes:
measure: Disease Progression at Day 28
timeFrame: 28 days
Secondary outcomes:
measure: Survival Rate
timeFrame: Up to Day 15 and Day 28
measure: Time to Fever Resolution
timeFrame: Up to 28 days
measure: Resolution of Viral Shedding
timeFrame: Day 1, Day 7 and Day 15
measure: Rate of Adverse Events and Serious Adverse Events
timeFrame: 28 days
measure: Cumulative Rate of Grade 3 and 4 Adverse Events
timeFrame: 28 days
measure: Rate of Discontinuation
timeFrame: 28 days
measure: Laboratory Parameter - Platelet Count
timeFrame: Day 1 and Day 15
measure: Laboratory Parameter - Potassium Level
timeFrame: Day 1 and Day 15
measure: Laboratory Parameter - Aspartate Aminotransferase (AST)
timeFrame: Day 1 and Day 15
measure: Laboratory Parameter - Alanine Aminotransferase (ALT)
timeFrame: Day 1 and Day 15
measure: Laboratory Parameter - Alkaline Phosphatase (ALP)
timeFrame: Day 1 and Day 15
measure: Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)
timeFrame: Day 1 and Day 15
measure: Vital Signs - Heart Rate
timeFrame: Day 1, Day 7 and Day 15
measure: Vital Signs - Blood Pressure
timeFrame: Day 1, Day 7 and Day 15
measure: Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)
timeFrame: Day 1, Day 7 and Day 15
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc. (Site 125)
state: California
city: Bradenton
country: United States
facility: Synergy Healthcare, LLC (Site 124)
state: Florida
city: Brandon
country: United States
facility: Clinical Research of Brandon, LLC (Site 123)
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research, LLC (Site 100)
state: Florida
city: Miami
country: United States
facility: A+ Research (Site 112)
state: Florida
city: Miami
country: United States
facility: NextPhase Research Alliance at CANO HEALTH (Site 107)
state: Florida
city: Miami
country: United States
facility: Ezy Medical Research (Site 106)
state: Florida
city: Plantation
country: United States
facility: Eminat LLC (Site 117)
state: Florida
city: Pompano Beach
country: United States
facility: Invictus Clinical Research Group, LLC (Site 101)
state: Florida
city: Atlanta
country: United States
facility: Visionaries Clinical Research, LLC (Site 121)
state: Georgia
city: Boise
country: United States
facility: Family Care Research (Site 114)
state: Idaho
city: Chicago
country: United States
facility: Cedar Crosse Research Center (Site 122)
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital (Site 110)
state: Massachusetts
city: Troy
country: United States
facility: Oakland Medical Research Center (Site 108)
state: Michigan
city: Cary
country: United States
facility: Cary Research Group (Site 111)
state: North Carolina
city: Charlotte
country: United States
facility: Onsite Solutions (Site 118)
state: North Carolina
city: Springboro
country: United States
facility: STAT Research (Site 109)
state: Ohio
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research, Inc.(Site 105)
state: Ohio
city: Georgetown
country: United States
facility: Advanced Medical Trials (Site 104)
state: Texas
city: Houston
country: United States
facility: Next Innovative Clinical Research (Site 115)
state: Texas
city: Pharr
country: United States
facility: Rio Grand Valley Clinical Research Institute (Site 120)
state: Texas
Study officials:
References: