Trial Outcomes & Findings for Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients (NCT NCT04524663)

Last Updated: 2022-06-10

Results Overview

AUC of shedding of SARS-CoV-2 virus calculated using the reverse transcription-polymerase chain reaction (RT-PCR) measures of viral load from self-collected nasal swabs on days 1-10. AUC was defined by a single participant's cycle threshold (Ct) from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

Days 1-10

Results posted on

2022-06-10

Participant Flow

After 49 participants were enrolled, this trial was subsumed into a pragmatic platform trial (the COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Camostat Sub-Protocol (NCT04662073). Additional subjects subsequently consented for camostat in the platform study. Their results are not included here.

Participant milestones

Participant milestones
Measure	Camostat Mesilate Camostat mesilate for 10 days in addition to standard of care treatment.	Placebo Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
Overall Study STARTED	25	24
Overall Study COMPLETED	25	22
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Camostat Mesilate Camostat mesilate for 10 days in addition to standard of care treatment.	Placebo Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Participants who provided ethnicity data are included in the analysis.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Days 1-10

Population: Patients with nasal swab data are included in the analysis.

Outcome measures

Outcome measures
Measure	Camostat Mesilate n=22 Participants Camostat mesilate for 10 days in addition to standard of care treatment.	Placebo n=24 Participants Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
Area Under the Curve (AUC) of Shedding of SARS-CoV-2 Virus	95.3 cycles*days Interval 66.7 to 124.0	93 cycles*days Interval 68.0 to 124.0

SECONDARY outcome

Timeframe: Days 1-10, 14, 21, and 28

Population: Patients with nasal swab data are included in the analysis.

AUC of shedding of SARS-CoV-2 virus calculated using the RT-PCR measures of viral load from self-collected nasal swabs on days 1-10, 14, 21, and 28. AUC was defined by a single participant's Ct from nasal swabs collected and calculated by the trapezoidal rule, using exact times of collection of each swab. Ct denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.

Outcome measures

Outcome measures
Measure	Camostat Mesilate n=22 Participants Camostat mesilate for 10 days in addition to standard of care treatment.	Placebo n=24 Participants Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
AUC of Shedding of SARS-CoV-2 Virus	116 cycles*days Interval 68.7 to 157.0	124 cycles*days Interval 71.8 to 169.0

SECONDARY outcome

Timeframe: Up to 28 days

Population: Patients with nasal swab data are included in the analysis.

This outcome is defined as the time in days from randomization to the first negative RT-PCR result of self-collected nasal swabs that is followed by only negative results (i.e. no later positive results are observed).

Outcome measures

Outcome measures
Measure	Camostat Mesilate n=22 Participants Camostat mesilate for 10 days in addition to standard of care treatment.	Placebo n=24 Participants Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
Time Until Cessation of Shedding of SARS-CoV-2 Virus	14 days Interval 7.0 to 21.0	21 days Interval 12.0 to Not estimable (curve did not reach the 75th percentile)

SECONDARY outcome

Timeframe: Up to 28 days

Number of symptomatic patients with clinical worsening, defined as the development of respiratory distress or symptoms that require hospitalization.

Outcome measures

Outcome measures
Measure	Camostat Mesilate n=25 Participants Camostat mesilate for 10 days in addition to standard of care treatment.	Placebo n=24 Participants Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
Clinical Worsening of COVID-19 Disease in Symptomatic Patients	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

This outcome is defined as absence of moderate or severe symptoms for at least 24 hours for those reporting moderate or severe symptoms at baseline.

Outcome measures

Outcome measures
Measure	Camostat Mesilate n=25 Participants Camostat mesilate for 10 days in addition to standard of care treatment.	Placebo n=24 Participants Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
Time Until Resolution of Symptoms	11 days Interval 5.0 to 16.0	12 days Interval 9.0 to Not estimable (curve did not reach the 75th percentile)

SECONDARY outcome

Timeframe: Up to 28 days

Population: Data were not collected for this outcome measure.

Number of patients that develop antibodies to SARS-CoV-2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 5, 1 hour post dose

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Camostat Mesilate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Camostat Mesilate n=25 participants at risk Camostat mesilate for 10 days in addition to standard of care treatment.	Placebo n=24 participants at risk Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
Investigations Liver function tests	0.00% 0/25 • 28 days	4.2% 1/24 • 28 days
Vascular disorders Hypotension	0.00% 0/25 • 28 days	4.2% 1/24 • 28 days
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/25 • 28 days	4.2% 1/24 • 28 days
Psychiatric disorders Suidical ideation	0.00% 0/25 • 28 days	4.2% 1/24 • 28 days

Other adverse events

Other adverse events
Measure	Camostat Mesilate n=25 participants at risk Camostat mesilate for 10 days in addition to standard of care treatment.	Placebo n=24 participants at risk Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.
Investigations Liver function test (LFT) elevation	4.0% 1/25 • 28 days	16.7% 4/24 • 28 days
Gastrointestinal disorders Diarrhea	4.0% 1/25 • 28 days	8.3% 2/24 • 28 days
Skin and subcutaneous tissue disorders Rash	0.00% 0/25 • 28 days	16.7% 4/24 • 28 days

Additional Information

Dr. Julie Parsonnet, MD

Stanford University

Phone: (650) 725-4561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Camostat Mesilate n=25 Participants Camostat mesilate for 10 days in addition to standard of care treatment.	Placebo n=24 Participants Placebo to match camostat mesilate for 10 days in addition to standard of care treatment.	Total n=49 Participants Total of all reporting groups
Age, Continuous	37.88 years STANDARD_DEVIATION 13.47 • n=25 Participants	40.54 years STANDARD_DEVIATION 14.27 • n=24 Participants	39.18 years STANDARD_DEVIATION 13.79 • n=49 Participants
Sex: Female, Male Female	10 Participants n=25 Participants	7 Participants n=24 Participants	17 Participants n=49 Participants
Sex: Female, Male Male	15 Participants n=25 Participants	17 Participants n=24 Participants	32 Participants n=49 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=24 Participants • Participants who provided ethnicity data are included in the analysis.	9 Participants n=22 Participants • Participants who provided ethnicity data are included in the analysis.	15 Participants n=46 Participants • Participants who provided ethnicity data are included in the analysis.
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=24 Participants • Participants who provided ethnicity data are included in the analysis.	13 Participants n=22 Participants • Participants who provided ethnicity data are included in the analysis.	31 Participants n=46 Participants • Participants who provided ethnicity data are included in the analysis.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants • Participants who provided ethnicity data are included in the analysis.	0 Participants n=22 Participants • Participants who provided ethnicity data are included in the analysis.	0 Participants n=46 Participants • Participants who provided ethnicity data are included in the analysis.
Race/Ethnicity, Customized American Indian/Alaska Native	1 Participants n=23 Participants • Participants who provided race data are included in the analysis.	0 Participants n=18 Participants • Participants who provided race data are included in the analysis.	1 Participants n=41 Participants • Participants who provided race data are included in the analysis.
Race/Ethnicity, Customized Asian	5 Participants n=23 Participants • Participants who provided race data are included in the analysis.	4 Participants n=18 Participants • Participants who provided race data are included in the analysis.	9 Participants n=41 Participants • Participants who provided race data are included in the analysis.
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=23 Participants • Participants who provided race data are included in the analysis.	0 Participants n=18 Participants • Participants who provided race data are included in the analysis.	1 Participants n=41 Participants • Participants who provided race data are included in the analysis.
Race/Ethnicity, Customized Black or African American	1 Participants n=23 Participants • Participants who provided race data are included in the analysis.	0 Participants n=18 Participants • Participants who provided race data are included in the analysis.	1 Participants n=41 Participants • Participants who provided race data are included in the analysis.
Race/Ethnicity, Customized White	12 Participants n=23 Participants • Participants who provided race data are included in the analysis.	7 Participants n=18 Participants • Participants who provided race data are included in the analysis.	19 Participants n=41 Participants • Participants who provided race data are included in the analysis.
Race/Ethnicity, Customized More than one race	0 Participants n=23 Participants • Participants who provided race data are included in the analysis.	1 Participants n=18 Participants • Participants who provided race data are included in the analysis.	1 Participants n=41 Participants • Participants who provided race data are included in the analysis.
Race/Ethnicity, Customized Unknown	1 Participants n=23 Participants • Participants who provided race data are included in the analysis.	0 Participants n=18 Participants • Participants who provided race data are included in the analysis.	1 Participants n=41 Participants • Participants who provided race data are included in the analysis.
Race/Ethnicity, Customized Other	2 Participants n=23 Participants • Participants who provided race data are included in the analysis.	6 Participants n=18 Participants • Participants who provided race data are included in the analysis.	8 Participants n=41 Participants • Participants who provided race data are included in the analysis.
Region of Enrollment United States	25 Participants n=25 Participants	24 Participants n=24 Participants	49 Participants n=49 Participants
Anterior nares RT-PCR Ct	19.40 cycles n=20 Participants • Participants with baseline data are included in the analysis.	21.58 cycles n=22 Participants • Participants with baseline data are included in the analysis.	20.87 cycles n=42 Participants • Participants with baseline data are included in the analysis.
Duration of Symptoms	5.00 days n=24 Participants • Participants with baseline data are included in the analysis.	4.50 days n=24 Participants • Participants with baseline data are included in the analysis.	5.00 days n=48 Participants • Participants with baseline data are included in the analysis.
Number of Symptoms	6 symptoms n=25 Participants	6 symptoms n=24 Participants	6 symptoms n=49 Participants
Body Mass Index	27.81 kg/m^2 n=25 Participants	28.00 kg/m^2 n=24 Participants	27.81 kg/m^2 n=49 Participants
Aspartate Aminotransferase	25.00 units/L n=25 Participants	30.00 units/L n=24 Participants	27.00 units/L n=49 Participants
Alanine Aminotransferase	25.00 units/L n=25 Participants	34.50 units/L n=24 Participants	29.00 units/L n=49 Participants
Uric acid	5.10 mg/dL n=23 Participants • Participants with baseline data are included in the analysis.	5.00 mg/dL n=24 Participants • Participants with baseline data are included in the analysis.	5.10 mg/dL n=47 Participants • Participants with baseline data are included in the analysis.
Creatinine	0.87 mg/dL n=25 Participants	0.86 mg/dL n=24 Participants	0.87 mg/dL n=49 Participants