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

• Sponsor: Sagent Pharmaceuticals Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04583592
• Collaborator: (none)
• Enrollment: 295
• Locations: 21
• Arms: 2
• Actual Duration (Months): 4.7
• Patients Per Site: 14
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Camostat Mesilate; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 295 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients
• Actual Study Start Date: Nov 9, 2020
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

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: Camostat Mesylate Foipan®
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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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).

7. Laboratory Parameter - Platelet Count [Day 1 and Day 15]

   Clinical Laboratory Value of Platelet Count at Day 1 and Day 15

8. Laboratory Parameter - Potassium Level [Day 1 and Day 15]

   Clinical laboratory value of Potassium Levels at Day 1 and Day 15

9. Laboratory Parameter - Aspartate Aminotransferase (AST) [Day 1 and Day 15]

   Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15

10. Laboratory Parameter - Alanine Aminotransferase (ALT) [Day 1 and Day 15]

    Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15

11. Laboratory Parameter - Alkaline Phosphatase (ALP) [Day 1 and Day 15]

    Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15

12. 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

13. Vital Signs - Heart Rate [Day 1, Day 7 and Day 15]

    Heart rate at Day 1, Day 7 and Day 15

14. Vital Signs - Blood Pressure [Day 1, Day 7 and Day 15]

    Blood pressure (BP) at Day 1, Day 7 and Day 15

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

6. Aged 65 years or older

7. Hypertension

8. Diabetes mellitus

9. Chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (eg, idiopathic pulmonary fibrosis)

10. Chronic cardiac conditions, including coronary artery disease (CAD), heart failure, congenital heart disease, cardiomyopathy

11. Severe obesity (body mass index [BMI] ≥ 40 kg/m^2)

12. Chronic liver disease, including cirrhosis

13. 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

14. 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)

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Sagent Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 7, 2020
• Statistical Analysis Plan - Mar 31, 2021

More Information

Publications

None provided.

• Responsible Party: Sagent Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT04583592
• Other Study ID Numbers: NI03-CV19-001
• First Posted: Oct 12, 2020
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Gabexate; Camostat

Study Results

Participant Flow

Recruitment Details	The study was performed between November 09, 2020 to March, 30 2021. Subjects were recruited from ~25 sites across United States.

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Period Title: Overall Study
STARTED	194	101
COMPLETED	194	100
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Camostat Mesilate	Placebo	Total
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.	Total of all reporting groups
Overall Participants	194	101	295
Age, Customized (Count of Participants)
< 55 years	105 54.1%	53 52.5%	158 53.6%
> or = 55 years	89 45.9%	48 47.5%	137 46.4%
Sex: Female, Male (Count of Participants)
Female	108 55.7%	61 60.4%	169 57.3%
Male	86 44.3%	40 39.6%	126 42.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	115 59.3%	62 61.4%	177 60%
Not Hispanic or Latino	78 40.2%	39 38.6%	117 39.7%
Unknown or Not Reported	1 0.5%	0 0%	1 0.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 1%	0 0%	2 0.7%
Asian	4 2.1%	1 1%	5 1.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	29 14.9%	17 16.8%	46 15.6%
White	153 78.9%	80 79.2%	233 79%
More than one race	3 1.5%	0 0%	3 1%
Unknown or Not Reported	3 1.5%	3 3%	6 2%

Outcome Measures

1. Primary Outcome

Title	Disease Progression at Day 28
Description	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.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population includes all subjects who were randomized

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
Count of Participants [Participants]	10 5.2%	6 5.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Camostat Mesilate, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.787
	Comments	<0.05
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Survival Rate
Description	The overall survival rate (the number of randomized participants who survive up to Day 15 and Day 28).
Time Frame	Up to Day 15 and Day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
Survival Status at Day 15	194 100%	101 100%
Survival Status at Day 28	193 99.5%	101 100%

3. Secondary Outcome

Title	Time to Fever Resolution
Description	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.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	18	5
Median (95% Confidence Interval) [Days]	3	1

4. Secondary Outcome

Title	Resolution of Viral Shedding
Description	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.
Time Frame	Day 1, Day 7 and Day 15

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
No Viral Shedding at Day 1	32 16.5%	25 24.8%
No Viral Shedding at Day 7	77 39.7%	36 35.6%
No Viral Shedding at Day 15	136 70.1%	65 64.4%

5. Secondary Outcome

Title	Rate of Adverse Events and Serious Adverse Events
Description	Number of participants with Adverse events (AEs) and Serious adverse events (SAEs) of any grade from randomization up to Day 28.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	195	99
Treatment Emergent Adverse Event (TEAE)	17 8.8%	13 12.9%
Serious TEAEs	10 5.2%	5 5%

6. Secondary Outcome

Title	Cumulative Rate of Grade 3 and 4 Adverse Events
Description	Cumulative number of participants with grade 3 and 4 AEs from randomization up to Day 28.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	195	99
Grade 3 AEs	6 3.1%	0 0%
Grade 4 AEs	1 0.5%	1 1%

7. Secondary Outcome

Title	Rate of Discontinuation
Description	Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28).
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat (ITT) population includes all subjects who were randomized.

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
Count of Participants [Participants]	11 5.7%	5 5%

8. Secondary Outcome

Title	Laboratory Parameter - Platelet Count
Description	Clinical Laboratory Value of Platelet Count at Day 1 and Day 15
Time Frame	Day 1 and Day 15

Outcome Measure Data

Analysis Population Description

The Intent-to Treat Population includes all subjects who were randomized.

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
Day 1 Platelet Count	243 (71.69)	252.1 (80.45)
Day 15 Platelet Count	288.3 (86.66)	281.5 (83.22)

9. Secondary Outcome

Title	Laboratory Parameter - Potassium Level
Description	Clinical laboratory value of Potassium Levels at Day 1 and Day 15
Time Frame	Day 1 and Day 15

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
Day 1 Potassium Level	4.26 (0.397)	4.23 (0.391)
Day 15 Potassium Level	4.30 (0.363)	4.29 (0.407)

10. Secondary Outcome

Title	Laboratory Parameter - Aspartate Aminotransferase (AST)
Description	Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15
Time Frame	Day 1 and Day 15

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population includes all subjects who were randomized.

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
Day 1 AST	24.6 (14.71)	25.3 (12.33)
Day 15 AST	21.8 (10.18)	21.8 (10.65)

11. Secondary Outcome

Title	Laboratory Parameter - Alanine Aminotransferase (ALT)
Description	Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15
Time Frame	Day 1 and Day 15

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population includes all subjects who were randomized.

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
Day 1 ALT	30.2 (27.58)	29.0 (17.01)
Day 15 ALT	27.9 (20.1)	27.9 (22.28)

12. Secondary Outcome

Title	Laboratory Parameter - Alkaline Phosphatase (ALP)
Description	Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15
Time Frame	Day 1 and Day 15

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population includes all subjects who were randomized.

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
Day 1 ALP	76.3 (24.44)	80.5 (25.55)
Day 15 ALP	77.8 (27.60)	78.6 (24.91)

13. Secondary Outcome

Title	Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)
Description	Clinical laboratory value of Gamma-Glutamyl Transferase (GGT) at Day 1 and Day 15
Time Frame	Day 1 and Day 15

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population includes all subjects who were randomized.

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
Day 1 GGT	33.5 (25.61)	33.4 (29.91)
Day 15 GGT	34.1 (30.50)	31.1 (20.30)

14. Secondary Outcome

Title	Vital Signs - Heart Rate
Description	Heart rate at Day 1, Day 7 and Day 15
Time Frame	Day 1, Day 7 and Day 15

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population includes all subjects who were randomized.

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
Heart rate Day 1	81.2 (10.25)	80.1 (10.48)
Heart rate Day 7	81.2 (10.07)	80.5 (9.09)
Heart rate Day 15	79.8 (10.16)	79.2 (9.94)

15. Secondary Outcome

Title	Vital Signs - Blood Pressure
Description	Blood pressure (BP) at Day 1, Day 7 and Day 15
Time Frame	Day 1, Day 7 and Day 15

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population includes all subjects who were randomized.

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
Systolic BP Day 1	128.7 (13.87)	129.6 (13.97)
Systolic BP Day 7	128.2 (16.61)	129.2 (15.54)
Systolic BP Day 15	128.1 (16.61)	129.2 (15.54)
Diastolic BP Day 1	80.7 (8.9)	80.8 (7.43)
Diastolic BP Day 7	80.2 (9.34)	80.9 (9.6)
Diastolic BP Day 15	78.9 (8.72)	81.3 (10.65)

16. Secondary Outcome

Title	Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)
Description	Peripheral Capillary Oxygen Saturation (SpO2) at Day 1, Day 7 and Day 15
Time Frame	Day 1, Day 7 and Day 15

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population includes all subjects who were randomized.

Arm/Group Title	Camostat Mesilate	Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.	Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
Measure Participants	194	101
SpO2 Day 1	97.3 (1.33)	97.4 (1.3)
SpO2 Day 7	97.3 (1.78)	97.3 (1.43)
SpO2 Day 15	97.6 (1.46)	97.5 (2.22)

Adverse Events

Time Frame	28 Days
Adverse Event Reporting Description	A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
Arm/Group Title	Camostat Mesilate		Placebo
Arm/Group Description	Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. 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.		Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
All Cause Mortality
	Camostat Mesilate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/195 (0.5%)		0/99 (0%)
Serious Adverse Events
	Camostat Mesilate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/195 (5.1%)		5/99 (5.1%)
Cardiac disorders
Myocardial Infarction	1/195 (0.5%)		0/99 (0%)
Gastrointestinal disorders
Diarrhea	1/195 (0.5%)		0/99 (0%)
General disorders
Fatigue	0/195 (0%)		2/99 (2%)
Pyrexia	1/195 (0.5%)		0/99 (0%)
Infections and infestations
Pneumonia	5/195 (2.6%)		2/99 (2%)
Investigations
Oxygen saturation decreased	2/195 (1%)		0/99 (0%)
Psychiatric disorders
Delusion	1/195 (0.5%)		0/99 (0%)
Renal and urinary disorders
Renal Failure	1/195 (0.5%)		0/99 (0%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome	2/195 (1%)		0/99 (0%)
Dyspnea	0/195 (0%)		1/99 (1%)
Hypoxia	0/195 (0%)		1/99 (1%)
Pleurisy	1/195 (0.5%)		0/99 (0%)
Vascular disorders
Hypotension	1/195 (0.5%)		0/99 (0%)
Other (Not Including Serious) Adverse Events
	Camostat Mesilate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/195 (4.1%)		9/99 (9.1%)
Gastrointestinal disorders
Abdominal Distension	2/195 (1%)		0/99 (0%)
Abdominal pain	0/195 (0%)		1/99 (1%)
Constipation	0/195 (0%)		2/99 (2%)
Diarrhea	1/195 (0.5%)		0/99 (0%)
Gastroesophageal Reflux Disease	1/195 (0.5%)		0/99 (0%)
General disorders
Fatigue	1/195 (0.5%)		0/99 (0%)
Pyrexia	0/195 (0%)		2/99 (2%)
Infections and infestations
Pneumonia	0/195 (0%)		1/99 (1%)
Injury, poisoning and procedural complications
Corneal abrasion	0/195 (0%)		1/99 (1%)
Investigations
Gamma-glutamyltransferase increased	0/195 (0%)		1/99 (1%)
Oxygen Saturation Decreased	0/195 (0%)		1/99 (1%)
Metabolism and nutrition disorders
Decreased apetite	1/195 (0.5%)		0/99 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/195 (0%)		1/99 (1%)
Nervous system disorders
Aguesia	1/195 (0.5%)		1/99 (1%)
Anosmia	1/195 (0.5%)		1/99 (1%)
Migraine	1/195 (0.5%)		0/99 (0%)
Psychiatric disorders
Anxiety	1/195 (0.5%)		0/99 (0%)
Insomnia	1/195 (0.5%)		0/99 (0%)
Renal and urinary disorders
Renal Failure	1/195 (0.5%)		0/99 (0%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome	2/195 (1%)		0/99 (0%)
Dyspnea	0/195 (0%)		1/99 (1%)
Productive cough	1/195 (0.5%)		0/99 (0%)
Skin and subcutaneous tissue disorders
Pruritus	1/195 (0.5%)		0/99 (0%)
Vascular disorders
Hypertension	0/195 (0%)		1/99 (1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.