Back to resultsCamostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Camostat Mesilate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Adults willing and able to provide informed consent before performing study procedures
- Adults ≥18 years of age at time of informed consent
- 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
- Have a mild or moderate form of COVID-19 defined as SpO2 > 94% at screening
Participants must have at least 1 of the following risk factors for severe illness
- Aged 65 years or older
- Hypertension
- Diabetes mellitus
- Chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (eg, idiopathic pulmonary fibrosis)
- Chronic cardiac conditions, including coronary artery disease (CAD), heart failure, congenital heart disease, cardiomyopathy
- Severe obesity (body mass index [BMI] ≥ 40 kg/m^2)
- Chronic liver disease, including cirrhosis
- 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
- 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:
- 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
- Known severe liver disease (eg, Child Pugh score > 12, AST >5 times upper limit)
- SaO2/SPO2 ≤94% on room air condition, or the Pa02/Fi02 ratio < 300 mgHg
- Known allergic reaction to camostat mesilate or one of its excipients
- Known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m^2) or receiving dialysis
- Pregnant or breastfeeding, or positive pregnancy test in a predose examination
- 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.
- History of human immunodeficiency virus infection on highly active antiretroviral therapy (HAART)
Sites / Locations
- Palmtree Clinical Research, Inc. (Site 125)
- Synergy Healthcare, LLC (Site 124)
- Clinical Research of Brandon, LLC (Site 123)
- Reliable Clinical Research, LLC (Site 100)
- A+ Research (Site 112)
- NextPhase Research Alliance at CANO HEALTH (Site 107)
- Ezy Medical Research (Site 106)
- Eminat LLC (Site 117)
- Invictus Clinical Research Group, LLC (Site 101)
- Visionaries Clinical Research, LLC (Site 121)
- Family Care Research (Site 114)
- Cedar Crosse Research Center (Site 122)
- Massachusetts General Hospital (Site 110)
- Oakland Medical Research Center (Site 108)
- Cary Research Group (Site 111)
- Onsite Solutions (Site 118)
- STAT Research (Site 109)
- Toledo Institute of Clinical Research, Inc.(Site 105)
- Advanced Medical Trials (Site 104)
- Next Innovative Clinical Research (Site 115)
- Rio Grand Valley Clinical Research Institute (Site 120)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Camostat Mesilate
Placebo
Arm Description
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Participants will receive placebo for 14 days in addition to standard of care treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Survival Rate
The overall survival rate (the number of randomized participants who survive 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.
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.
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.
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.
Rate of Discontinuation
Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28).
Laboratory Parameter - Platelet Count
Clinical Laboratory Value of Platelet Count at Day 1 and Day 15
Laboratory Parameter - Potassium Level
Clinical laboratory value of Potassium Levels at Day 1 and Day 15
Laboratory Parameter - Aspartate Aminotransferase (AST)
Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15
Laboratory Parameter - Alanine Aminotransferase (ALT)
Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15
Laboratory Parameter - Alkaline Phosphatase (ALP)
Clinical laboratory value of Alkaline Phosphatase (ALP) at 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
Vital Signs - Heart Rate
Heart rate at Day 1, Day 7 and Day 15
Vital Signs - Blood Pressure
Blood pressure (BP) at 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
Full Information
NCT ID
NCT04583592
First Posted
October 7, 2020
Last Updated
January 13, 2022
Sponsor
Sagent Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04583592
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sagent Pharmaceuticals Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Camostat Mesilate
Arm Type
Experimental
Arm Description
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo for 14 days in addition to standard of care treatment.
Intervention Type
Drug
Intervention Name(s)
Camostat Mesilate
Other Intervention Name(s)
Camostat Mesylate, Foipan®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Primary Outcome Measure Information:
Title
Disease Progression at Day 28
Description
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
Secondary Outcome Measure Information:
Title
Survival Rate
Description
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
Title
Time to Fever Resolution
Description
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
Title
Resolution of Viral Shedding
Description
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
Title
Rate of Adverse Events and Serious Adverse Events
Description
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
Title
Cumulative Rate of Grade 3 and 4 Adverse Events
Description
Cumulative number of participants with grade 3 and 4 AEs from randomization up to Day 28.
Time Frame
28 days
Title
Rate of Discontinuation
Description
Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28).
Time Frame
28 days
Title
Laboratory Parameter - Platelet Count
Description
Clinical Laboratory Value of Platelet Count at Day 1 and Day 15
Time Frame
Day 1 and Day 15
Title
Laboratory Parameter - Potassium Level
Description
Clinical laboratory value of Potassium Levels at Day 1 and Day 15
Time Frame
Day 1 and Day 15
Title
Laboratory Parameter - Aspartate Aminotransferase (AST)
Description
Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15
Time Frame
Day 1 and Day 15
Title
Laboratory Parameter - Alanine Aminotransferase (ALT)
Description
Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15
Time Frame
Day 1 and Day 15
Title
Laboratory Parameter - Alkaline Phosphatase (ALP)
Description
Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15
Time Frame
Day 1 and Day 15
Title
Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)
Description
Clinical laboratory value of Gamma-Glutamyl Transferase (GGT) at Day 1 and Day 15
Time Frame
Day 1 and Day 15
Title
Vital Signs - Heart Rate
Description
Heart rate at Day 1, Day 7 and Day 15
Time Frame
Day 1, Day 7 and Day 15
Title
Vital Signs - Blood Pressure
Description
Blood pressure (BP) at Day 1, Day 7 and Day 15
Time Frame
Day 1, Day 7 and Day 15
Title
Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)
Description
Peripheral Capillary Oxygen Saturation (SpO2) at Day 1, Day 7 and Day 15
Time Frame
Day 1, Day 7 and Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults willing and able to provide informed consent before performing study procedures
Adults ≥18 years of age at time of informed consent
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
Have a mild or moderate form of COVID-19 defined as SpO2 > 94% at screening
Participants must have at least 1 of the following risk factors for severe illness
Aged 65 years or older
Hypertension
Diabetes mellitus
Chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (eg, idiopathic pulmonary fibrosis)
Chronic cardiac conditions, including coronary artery disease (CAD), heart failure, congenital heart disease, cardiomyopathy
Severe obesity (body mass index [BMI] ≥ 40 kg/m^2)
Chronic liver disease, including cirrhosis
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
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:
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
Known severe liver disease (eg, Child Pugh score > 12, AST >5 times upper limit)
SaO2/SPO2 ≤94% on room air condition, or the Pa02/Fi02 ratio < 300 mgHg
Known allergic reaction to camostat mesilate or one of its excipients
Known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m^2) or receiving dialysis
Pregnant or breastfeeding, or positive pregnancy test in a predose examination
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.
History of human immunodeficiency virus infection on highly active antiretroviral therapy (HAART)
Facility Information:
Facility Name
Palmtree Clinical Research, Inc. (Site 125)
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Synergy Healthcare, LLC (Site 124)
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Clinical Research of Brandon, LLC (Site 123)
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Reliable Clinical Research, LLC (Site 100)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
A+ Research (Site 112)
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
NextPhase Research Alliance at CANO HEALTH (Site 107)
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Ezy Medical Research (Site 106)
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Eminat LLC (Site 117)
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Invictus Clinical Research Group, LLC (Site 101)
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Visionaries Clinical Research, LLC (Site 121)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Family Care Research (Site 114)
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Cedar Crosse Research Center (Site 122)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Massachusetts General Hospital (Site 110)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Oakland Medical Research Center (Site 108)
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Cary Research Group (Site 111)
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Onsite Solutions (Site 118)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Facility Name
STAT Research (Site 109)
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Facility Name
Toledo Institute of Clinical Research, Inc.(Site 105)
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Advanced Medical Trials (Site 104)
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628
Country
United States
Facility Name
Next Innovative Clinical Research (Site 115)
City
Houston
State/Province
Texas
ZIP/Postal Code
77021
Country
United States
Facility Name
Rio Grand Valley Clinical Research Institute (Site 120)
City
Pharr
State/Province
Texas
ZIP/Postal Code
78577
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)
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