Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Camostat Mesilate; Drug: Placebo

• Registration Number: NCT04583592
• Lead Sponsor: Sagent Pharmaceuticals Inc.

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.

Study Timeline

• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-12
• Study Start: 2020-11-09
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Results First Submitted: 2021-12-14
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-13
• Last Update Submitted: 2022-01-13
• Results First Posted: 2022-01-18
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Camostat Mesilate	Camostat Mesilate	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Placebo	Placebo	Participants will receive placebo for 14 days in addition to standard of care treatment.

Primary Outcome Measures

Name	Time	Method
Disease Progression at Day 28	28 days	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

Name	Time	Method
Time to Fever Resolution	Up to 28 days	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.
Rate of Adverse Events and Serious Adverse Events	28 days	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	28 days	Cumulative number of participants with grade 3 and 4 AEs from randomization up to Day 28.
Laboratory Parameter - Alanine Aminotransferase (ALT)	Day 1 and Day 15	Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15
Vital Signs - Heart Rate	Day 1, Day 7 and Day 15	Heart rate at Day 1, Day 7 and Day 15
Survival Rate	Up to Day 15 and Day 28	The overall survival rate (the number of randomized participants who survive up to Day 15 and Day 28).
Rate of Discontinuation	28 days	Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28).
Laboratory Parameter - Potassium Level	Day 1 and Day 15	Clinical laboratory value of Potassium Levels at Day 1 and Day 15
Laboratory Parameter - Alkaline Phosphatase (ALP)	Day 1 and Day 15	Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15
Vital Signs - Blood Pressure	Day 1, Day 7 and Day 15	Blood pressure (BP) at Day 1, Day 7 and Day 15
Resolution of Viral Shedding	Day 1, Day 7 and Day 15	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.
Laboratory Parameter - Platelet Count	Day 1 and Day 15	Clinical Laboratory Value of Platelet Count at Day 1 and Day 15
Laboratory Parameter - Aspartate Aminotransferase (AST)	Day 1 and Day 15	Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15
Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)	Day 1 and Day 15	Clinical laboratory value of Gamma-Glutamyl Transferase (GGT) at Day 1 and Day 15
Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)	Day 1, Day 7 and Day 15	Peripheral Capillary Oxygen Saturation (SpO2) at Day 1, Day 7 and Day 15

Trial Locations

Locations (21)

Ezy Medical Research (Site 106); 🇺🇸 Miami, Florida, United States

Visionaries Clinical Research, LLC (Site 121); 🇺🇸 Atlanta, Georgia, United States

Synergy Healthcare, LLC (Site 124); 🇺🇸 Bradenton, Florida, United States

Next Innovative Clinical Research (Site 115); 🇺🇸 Houston, Texas, United States

A+ Research (Site 112); 🇺🇸 Miami, Florida, United States

Eminat LLC (Site 117); 🇺🇸 Plantation, Florida, United States

Cedar Crosse Research Center (Site 122); 🇺🇸 Chicago, Illinois, United States

Reliable Clinical Research, LLC (Site 100); 🇺🇸 Hialeah, Florida, United States

Family Care Research (Site 114); 🇺🇸 Boise, Idaho, United States

Palmtree Clinical Research, Inc. (Site 125); 🇺🇸 Palm Springs, California, United States

Cary Research Group (Site 111); 🇺🇸 Cary, North Carolina, United States

Advanced Medical Trials (Site 104); 🇺🇸 Georgetown, Texas, United States

Onsite Solutions (Site 118); 🇺🇸 Charlotte, North Carolina, United States

STAT Research (Site 109); 🇺🇸 Springboro, Ohio, United States

Toledo Institute of Clinical Research, Inc.(Site 105); 🇺🇸 Toledo, Ohio, United States

Rio Grand Valley Clinical Research Institute (Site 120); 🇺🇸 Pharr, Texas, United States

Invictus Clinical Research Group, LLC (Site 101); 🇺🇸 Pompano Beach, Florida, United States

NextPhase Research Alliance at CANO HEALTH (Site 107); 🇺🇸 Miami, Florida, United States

Clinical Research of Brandon, LLC (Site 123); 🇺🇸 Brandon, Florida, United States

Massachusetts General Hospital (Site 110); 🇺🇸 Boston, Massachusetts, United States

Oakland Medical Research Center (Site 108); 🇺🇸 Troy, Michigan, United States