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

NCT ID: NCT04583592

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2021-03-31

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Camostat Mesilate

Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.

Group Type: EXPERIMENTAL

Camostat Mesilate

Intervention Type: DRUG

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

Participants will receive placebo for 14 days in addition to standard of care treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.

Intervention Type: DRUG

Other Intervention Names

Camostat Mesylate; Foipan®

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sagent Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Palmtree Clinical Research, Inc. (Site 125)

Palm Springs, California, United States

Synergy Healthcare, LLC (Site 124)

Bradenton, Florida, United States

Clinical Research of Brandon, LLC (Site 123)

Brandon, Florida, United States

Reliable Clinical Research, LLC (Site 100)

Hialeah, Florida, United States

A+ Research (Site 112)

Miami, Florida, United States

NextPhase Research Alliance at CANO HEALTH (Site 107)

Miami, Florida, United States

Ezy Medical Research (Site 106)

Miami, Florida, United States

Eminat LLC (Site 117)

Plantation, Florida, United States

Invictus Clinical Research Group, LLC (Site 101)

Pompano Beach, Florida, United States

Visionaries Clinical Research, LLC (Site 121)

Atlanta, Georgia, United States

Family Care Research (Site 114)

Boise, Idaho, United States

Cedar Crosse Research Center (Site 122)

Chicago, Illinois, United States

Massachusetts General Hospital (Site 110)

Boston, Massachusetts, United States

Oakland Medical Research Center (Site 108)

Troy, Michigan, United States

Cary Research Group (Site 111)

Cary, North Carolina, 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

Advanced Medical Trials (Site 104)

Georgetown, Texas, United States

Next Innovative Clinical Research (Site 115)

Houston, Texas, United States

Rio Grand Valley Clinical Research Institute (Site 120)

Pharr, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NI03-CV19-001

Identifier Type: -

Identifier Source: org_study_id