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

COVID-19 Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04583592
• Other study ID #: NI03-CV19-001
• Status: Completed
• Phase: Phase 2
• Start date: November 9, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2022
• Source: Sagent Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sagent Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Laboratory Parameter - Platelet Count	Clinical Laboratory Value of Platelet Count at Day 1 and Day 15	Day 1 and Day 15
Secondary	Laboratory Parameter - Potassium Level	Clinical laboratory value of Potassium Levels at Day 1 and Day 15	Day 1 and Day 15
Secondary	Laboratory Parameter - Aspartate Aminotransferase (AST)	Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15	Day 1 and Day 15
Secondary	Laboratory Parameter - Alanine Aminotransferase (ALT)	Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15	Day 1 and Day 15
Secondary	Laboratory Parameter - Alkaline Phosphatase (ALP)	Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15	Day 1 and Day 15
Secondary	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
Secondary	Vital Signs - Heart Rate	Heart rate at Day 1, Day 7 and Day 15	Day 1, Day 7 and Day 15
Secondary	Vital Signs - Blood Pressure	Blood pressure (BP) at Day 1, Day 7 and Day 15	Day 1, Day 7 and Day 15
Secondary	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