Trial Outcomes & Findings for Camostat Mesylate in COVID-19 Outpatients (NCT NCT04353284)

NCT ID: NCT04353284

Last Updated: 2022-03-24

Results Overview

To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 4 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: 5 days (day 0 to day 4)
• Results posted on: 2022-03-24

Participant Flow

Participant milestones

Measure	Camostat Mesylate Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Overall Study STARTED	35	35
Overall Study COMPLETED	33	34
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Camostat Mesylate Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Camostat Mesylate in COVID-19 Outpatients

Baseline characteristics by cohort

Measure	Camostat Mesylate n=35 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=35 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.	Total n=70 Participants Total of all reporting groups
Age, Continuous	44.1 years STANDARD_DEVIATION 14.6 • n=93 Participants	44.1 years STANDARD_DEVIATION 12.0 • n=4 Participants	44.1 years STANDARD_DEVIATION 13.3 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	15 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	20 Participants n=4 Participants	42 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=93 Participants	32 Participants n=4 Participants	62 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	28 Participants n=93 Participants	29 Participants n=4 Participants	57 Participants n=27 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment United States	35 participants n=93 Participants	35 participants n=4 Participants	70 participants n=27 Participants

PRIMARY outcome

Timeframe: 5 days (day 0 to day 4)

Population: Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment.

To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 4 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.

Outcome measures

Measure	Camostat Mesylate n=35 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=35 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Change in SARS-COV-2 Viral Load Day 0	6.5 log10 copies/mL Interval 6.0 to 6.9	6.5 log10 copies/mL Interval 6.0 to 6.9
Change in SARS-COV-2 Viral Load Day 4	4.4 log10 copies/mL Interval 3.8 to 5.1	3.7 log10 copies/mL Interval 3.0 to 4.3
Change in SARS-COV-2 Viral Load Change (Day 4 - Day 0)	-2.0 log10 copies/mL Interval -2.6 to -1.5	-2.8 log10 copies/mL Interval -3.3 to -2.2

SECONDARY outcome

Timeframe: 3 days (day 0 to day 2)

Population: Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment.

To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 2 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.

Outcome measures

Measure	Camostat Mesylate n=35 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=35 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Change in SARS-COV-2 Viral Load	-1.2 log10 copies/mL Interval -1.8 to -0.6	-1.3 log10 copies/mL Interval -1.8 to -0.7

SECONDARY outcome

Timeframe: 7 days (day 0 to day 6)

Population: Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment.

To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 6 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.

Outcome measures

Measure	Camostat Mesylate n=35 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=35 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Change in SARS-COV-2 Viral Load	-3.6 log10 copies/mL Interval -4.5 to -2.8	-3.9 log10 copies/mL Interval -4.7 to -3.0

SECONDARY outcome

Timeframe: 7 days

Population: Intention to treat analysis using all participants with data at 7 days, 14 days and 28 days. The model excluded those with baseline data only (1 Camostat, 1 Placebo). Participants with valid data are presented at 7 days.

Change in risk for a positive COVID-19 test at day 6 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm.

Outcome measures

Measure	Camostat Mesylate n=34 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=34 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Number of Participants With Change in Positive COVID-19 Status Nasopharyngeal Swab Samples · Positive	17 Participants	18 Participants
Number of Participants With Change in Positive COVID-19 Status Nasopharyngeal Swab Samples · Negative	5 Participants	7 Participants
Number of Participants With Change in Positive COVID-19 Status Saliva RT-PCR · Positive	14 Participants	21 Participants
Number of Participants With Change in Positive COVID-19 Status Saliva RT-PCR · Negative	8 Participants	4 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Intention to treat analysis using all participants with data at 7 days, 14 days and 28 days. The model excluded those with baseline data only (1 Camostat, 1 Placebo). Participants with valid data are presented at 14 days.

Change in risk for a positive COVID-19 test at day 13 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm.

Outcome measures

Measure	Camostat Mesylate n=34 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=34 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Number of Participants With Change in Positive COVID-19 Status Nasopharyngeal Swab Samples · Positive	21 Participants	12 Participants
Number of Participants With Change in Positive COVID-19 Status Nasopharyngeal Swab Samples · Negative	12 Participants	21 Participants
Number of Participants With Change in Positive COVID-19 Status Saliva RT-PCR · Positive	16 Participants	14 Participants
Number of Participants With Change in Positive COVID-19 Status Saliva RT-PCR · Negative	17 Participants	18 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Intention to treat analysis using all participants with data at 7 days, 14 days and 28 days. The model excluded those with baseline data only (1 Camostat, 1 Placebo). Participants with valid data are presented at 28 days.

Number of Participants With Change in Positive COVID-19 Status

Outcome measures

Measure	Camostat Mesylate n=34 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=34 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Change in Positive COVID-19 Status Nasopharyngeal Swab Samples · Negative	27 Participants	33 Participants
Change in Positive COVID-19 Status Saliva RT-PCR · Positive	5 Participants	6 Participants
Change in Positive COVID-19 Status Nasopharyngeal Swab Samples · Positive	5 Participants	1 Participants
Change in Positive COVID-19 Status Saliva RT-PCR · Negative	27 Participants	28 Participants

SECONDARY outcome

Timeframe: Day 0 to Day 6

Population: Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment.

Change of COVID-19 symptom severity from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.

Outcome measures

Measure	Camostat Mesylate n=35 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=35 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Change in COVID-19 Symptom Severity Day 0	31.5 score on a scale Interval 27.3 to 35.8	31.5 score on a scale Interval 27.3 to 35.8
Change in COVID-19 Symptom Severity Day 6	12.4 score on a scale Interval 7.3 to 17.5	19.1 score on a scale Interval 14.0 to 24.1

SECONDARY outcome

Timeframe: Day 0 to Day 13

Population: Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment.

Change of COVID-19 symptom severity from day 0 to day 14 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.

Outcome measures

Measure	Camostat Mesylate n=35 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=35 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Change in COVID-19 Symptom Severity Day 0	31.5 score on a scale Interval 27.3 to 35.8	31.5 score on a scale Interval 27.3 to 35.8
Change in COVID-19 Symptom Severity Day 13	7.8 score on a scale Interval 2.5 to 13.2	9.9 score on a scale Interval 4.8 to 15.1

SECONDARY outcome

Timeframe: Day 0 to Day 6

Population: Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment.

Change of COVID-19 symptom frequency score from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 34-38 measure the frequency of specific daily symptoms and are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score (20) indicates the greatest burden of symptom frequency, the lowest possible score (0) indicates no frequency of symptoms.

Outcome measures

Measure	Camostat Mesylate n=35 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=35 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Change in COVID-19 Symptom Frequency Day 0	5.9 score on a scale Interval 5.0 to 6.8	5.9 score on a scale Interval 5.0 to 6.8
Change in COVID-19 Symptom Frequency Day 6	5.0 score on a scale Interval 3.9 to 6.2	4.1 score on a scale Interval 3.0 to 5.2

SECONDARY outcome

Timeframe: Day 0 to Day 13

Population: Intention to treat, baseline is pooled across treatment arms in the mixed models analysis as Day 0/Baseline data were collected prior to treatment.

Change of COVID-19 symptom frequency score from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 34-38 measure the frequency of specific daily symptoms and are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score (20) indicates the greatest burden of symptom frequency, the lowest possible score (0) indicates no frequency of symptoms.

Outcome measures

Measure	Camostat Mesylate n=35 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=35 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Change in COVID-19 Symptom Frequency Day 0	5.9 score on a scale Interval 5.0 to 6.8	5.9 score on a scale Interval 5.0 to 6.8
Change in COVID-19 Symptom Frequency Day 13	2.7 score on a scale Interval 1.5 to 4.0	2.1 score on a scale Interval 0.9 to 3.2

SECONDARY outcome

Timeframe: 7 days (Day 0 to Day 6)

Population: Data are presented for those with valid temperature data. Body temperature was not evenly collected at all visits as originally intended.

Change of COVID-19 symptom score from baseline to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.

Outcome measures

Measure	Camostat Mesylate n=22 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=27 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Change in Body Temperature Day 0	98.5 degrees Fahrenheit Standard Deviation 0.8	98.3 degrees Fahrenheit Standard Deviation 0.8
Change in Body Temperature Day 6	98.0 degrees Fahrenheit Standard Deviation 1.0	98.1 degrees Fahrenheit Standard Deviation 0.7

SECONDARY outcome

Timeframe: 28 days

Population: Data are presented for those with valid temperature data. Body temperature was not evenly collected at all visits as originally intended.

Change of COVID-19 symptom score from baseline to 28 days will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.

Outcome measures

Measure	Camostat Mesylate n=22 Participants Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=27 Participants Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Change in Body Temperature Day 0	98.5 degrees Fahrenheit Standard Deviation 0.8	98.3 degrees Fahrenheit Standard Deviation 0.8
Change in Body Temperature Day 27	97.8 degrees Fahrenheit Standard Deviation 0.5	97.7 degrees Fahrenheit Standard Deviation 0.8

Adverse Events

Camostat Mesylate

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Camostat Mesylate n=35 participants at risk Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=35 participants at risk Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	2.9% 1/35 • Number of events 1 • Up to 28 days	0.00% 0/35 • Up to 28 days
Respiratory, thoracic and mediastinal disorders Respiratory Infection	2.9% 1/35 • Number of events 1 • Up to 28 days	0.00% 0/35 • Up to 28 days

Other adverse events

Measure	Camostat Mesylate n=35 participants at risk Camostat mesylate 200mg taken 7 days. Camostat Mesilate: Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.	Placebo n=35 participants at risk Placebo taken for 7 days. Placebo: Placebo taken orally, 4 times daily, for 7 days.
Skin and subcutaneous tissue disorders Pruritus	8.6% 3/35 • Number of events 3 • Up to 28 days	0.00% 0/35 • Up to 28 days

Additional Information

Geoffrey Chupp, MD Professor of Medicine (Pulmonary); Director, Yale Center for Asthma and Airways D

Yale School of Medicine

Phone: (203) 785-3627

Email: geoffrey.chupp@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place