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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Camostat Mesilate; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 295
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Palm Springs, California, United States, 92262
      • Palmtree Clinical Research, Inc. (Site 125)
  • Florida
    • Bradenton, Florida, United States, 34208
      • Synergy Healthcare, LLC (Site 124)
    • Brandon, Florida, United States, 33511
      • Clinical Research of Brandon, LLC (Site 123)
    • Hialeah, Florida, United States, 33012
      • Reliable Clinical Research, LLC (Site 100)
    • Miami, Florida, United States, 33144
      • A+ Research (Site 112)
    • Miami, Florida, United States, 33144
      • NextPhase Research Alliance at CANO HEALTH (Site 107)
    • Miami, Florida, United States, 33175
      • Ezy Medical Research (Site 106)
    • Plantation, Florida, United States, 33317
      • Eminat LLC (Site 117)
    • Pompano Beach, Florida, United States, 33064
      • Invictus Clinical Research Group, LLC (Site 101)
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Visionaries Clinical Research, LLC (Site 121)
  • Idaho
    • Boise, Idaho, United States, 83704
      • Family Care Research (Site 114)
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar Crosse Research Center (Site 122)
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital (Site 110)
  • Michigan
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research Center (Site 108)
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Cary Research Group (Site 111)
    • Charlotte, North Carolina, United States, 28208
      • Onsite Solutions (Site 118)
  • Ohio
    • Springboro, Ohio, United States, 45066
      • STAT Research (Site 109)
    • Toledo, Ohio, United States, 43617
      • Toledo Institute of Clinical Research, Inc.(Site 105)
  • Texas
    • Georgetown, Texas, United States, 78628
      • Advanced Medical Trials (Site 104)
    • Houston, Texas, United States, 77021
      • Next Innovative Clinical Research (Site 115)
    • Pharr, Texas, United States, 78577
      • Rio Grand Valley Clinical Research Institute (Site 120)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camostat Mesilate; Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.	Drug: Camostat Mesilate; 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.; Other Names: Foipan®; Camostat Mesylate
Placebo Comparator: Placebo; Participants will receive placebo for 14 days in addition to standard of care treatment.	Drug: Placebo; Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Rate	The overall survival rate (the number of randomized participants who survive up to Day 15 and Day 28).	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.	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.	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.	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.	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).	28 days
Laboratory Parameter - Platelet Count	Clinical Laboratory Value of Platelet Count at Day 1 and Day 15	Day 1 and Day 15
Laboratory Parameter - Potassium Level	Clinical laboratory value of Potassium Levels at Day 1 and Day 15	Day 1 and Day 15
Laboratory Parameter - Aspartate Aminotransferase (AST)	Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15	Day 1 and Day 15
Laboratory Parameter - Alanine Aminotransferase (ALT)	Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15	Day 1 and Day 15
Laboratory Parameter - Alkaline Phosphatase (ALP)	Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15	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	Day 1 and Day 15
Vital Signs - Heart Rate	Heart rate at Day 1, Day 7 and Day 15	Day 1, Day 7 and Day 15
Vital Signs - Blood Pressure	Blood pressure (BP) at Day 1, Day 7 and Day 15	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	Day 1, Day 7 and Day 15

Collaborators and Investigators

• Sponsor: Sagent Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Anticoagulants; Trypsin Inhibitors; Camostat; Gabexate
• Other Study ID Numbers: NI03-CV19-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No