Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients
1 other identifier
interventional
295
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Nov 2020
Shorter than P25 for phase_2 covid19
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 12, 2020
CompletedStudy Start
First participant enrolled
November 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedResults Posted
Study results publicly available
January 18, 2022
CompletedJanuary 18, 2022
January 1, 2022
5 months
October 7, 2020
December 14, 2021
January 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
28 days
Secondary Outcomes (15)
Survival Rate
Up to Day 15 and Day 28
Time to Fever Resolution
Up to 28 days
Resolution of Viral Shedding
Day 1, Day 7 and Day 15
Rate of Adverse Events and Serious Adverse Events
28 days
Cumulative Rate of Grade 3 and 4 Adverse Events
28 days
- +10 more secondary outcomes
Study Arms (2)
Camostat Mesilate
EXPERIMENTALParticipants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Placebo
PLACEBO COMPARATORParticipants will receive placebo for 14 days in addition to standard of care treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Palmtree Clinical Research, Inc. (Site 125)
Palm Springs, California, 92262, United States
Synergy Healthcare, LLC (Site 124)
Bradenton, Florida, 34208, United States
Clinical Research of Brandon, LLC (Site 123)
Brandon, Florida, 33511, United States
Reliable Clinical Research, LLC (Site 100)
Hialeah, Florida, 33012, United States
A+ Research (Site 112)
Miami, Florida, 33144, United States
NextPhase Research Alliance at CANO HEALTH (Site 107)
Miami, Florida, 33144, United States
Ezy Medical Research (Site 106)
Miami, Florida, 33175, United States
Eminat LLC (Site 117)
Plantation, Florida, 33317, United States
Invictus Clinical Research Group, LLC (Site 101)
Pompano Beach, Florida, 33064, United States
Visionaries Clinical Research, LLC (Site 121)
Atlanta, Georgia, 30318, United States
Family Care Research (Site 114)
Boise, Idaho, 83704, United States
Cedar Crosse Research Center (Site 122)
Chicago, Illinois, 60607, United States
Massachusetts General Hospital (Site 110)
Boston, Massachusetts, 02114, United States
Oakland Medical Research Center (Site 108)
Troy, Michigan, 48085, United States
Cary Research Group (Site 111)
Cary, North Carolina, 27518, United States
Onsite Solutions (Site 118)
Charlotte, North Carolina, 28208, United States
STAT Research (Site 109)
Springboro, Ohio, 45066, United States
Toledo Institute of Clinical Research, Inc.(Site 105)
Toledo, Ohio, 43617, United States
Advanced Medical Trials (Site 104)
Georgetown, Texas, 78628, United States
Next Innovative Clinical Research (Site 115)
Houston, Texas, 77021, United States
Rio Grand Valley Clinical Research Institute (Site 120)
Pharr, Texas, 78577, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cynthia Tinkoff, Pharm.D. Manager, Medical Affairs
- Organization
- Sagent Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 12, 2020
Study Start
November 9, 2020
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
January 18, 2022
Results First Posted
January 18, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share