Covid19
Conditions
Keywords
Outpatient
Brief summary
The overall objective of this study is to efficiently evaluate the clinical efficacy and safety of different investigational therapeutics among adults who have COVID-19 but are not yet sick enough to require hospitalization. The overall hypothesis is that through an adaptive trial design, potential effective therapies (single and combination) may be identified for this group of patients. COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the platform, every investigational product will collect data for both Domain primary endpoints. Individual treatments to be evaluated in the platform will be described in separate sub-protocols.
Detailed description
The platform study allows investigational products with objectives either: evaluating viral shedding (Virology Domain); and COVID-19 related Clinical Outcomes (Clinical Domain). The primary objective for investigational products within the Viral Domain is: A. To evaluate the efficacy of each therapeutic intervention in addition to standard supportive care (SSC) compared with SSC in reducing viral shedding of SARS-CoV-2 virus in outpatients with COVID-19 disease. The primary objective for investigational products within for the Clinical Domain is: B. To evaluate the efficacy of each therapeutic intervention in addition to SSC as compared to SSC in improving sustained clinical outcomes in outpatients with COVID-19 disease. Secondary objectives are: 1. The objective of the non-assigned domain an investigational product is under. 1. If under Clinical Domain, reduction in viral shedding. 2. If under Viral Domain, time to resolution of symptoms. 2. To evaluate the efficacy of each therapeutic intervention in reducing SARS-CoV-2 related hospitalizations, ED visits, or death in outpatients with COVID-19 disease. 3. To assess the development of antibodies against SARS-CoV-2 4. To evaluate the safety and tolerability of each therapeutic intervention compared with placebo (supportive care).
Interventions
DRUGCamostat
200 mg (2 x 100 mg tablet) administered orally four times daily (800 mg total daily dose).
DRUGPlacebo
Placebo to match camostat administered orally four times daily
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 1\. Outpatient setting 2. Age ≥ 18 years and ≤ 80 years at the time of the assessment 3. Able and willing to understand the study, adhere to all study procedures, and provide written informed consent 4. Initial diagnosis of COVID-19 disease as defined by an FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 with no more than 72 hours from the initial swab used in the diagnosis to the time of commencing informed consent. 5. At baseline, at least two symptoms should have mild or higher severity score, where at least one of the mild symptoms is not cough, fatigue, or loss of smell/taste OR at least one symptom has a moderate or higher severity score on the COVID Outpatient Symptom Scale (COSS). 6. Participant's COVID-19 related symptom onset occurred within 7 days prior to time of randomization. 7. Other inclusion criteria specific to the investigational product that may, in the eyes of the investigator, be deemed necessary. Additional inclusion criteria for camostat protocol: 1. If male, must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication 2. If female, must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication, and must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy.
Exclusion criteria
1. At screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission. 2. Previous use of experimental drugs that may be active against COVID-19 in the eyes of the investigators. 3. Participant yields a positive urine pregnancy test at screening. 4. Participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19. 5. Participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus \[HIV\], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). 6. Has renal insufficiency including severe renal impairment and ESRD and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). 7. Has liver impairment greater than Child Pugh A. 8. Has a history of alcohol or drug abuse in the previous 6 months. 9. Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. 10. Has taken another investigational drug within the past 30 days. 11. Is deemed by the Investigator to be ineligible for any reason. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| For the Viral Domain: Change in Viral Shedding | 10 days | The number of participants who had viral shedding at Day 10 is reported. Change in shedding of SARS-CoV-2 virus through day 10 attained from self-collected nasal swab RT-PCR data after transformation using a referenced standard curve. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| For Clinical Domain: Time-to-sustained-resolution | 28 days | The number of participants with sustained resolution by Day 28 is reported. Resolution is defined as the first day where no symptoms are self-reported on all succeeding days through and including day 28, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none. |
| Time to Viral Cessation | 28 days | Defined as the time in days from randomization to the first of two consecutive negative RT-PCR results of self-collected nasal swabs. |
| Time to First Resolution | 28 days | The number of participants with first resolution by Day 28 is reported. First resolution is defined as the first study day where no symptoms are self-reported, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none. |
| Indicator Participant Has a Negative SARS-CoV2 RT-PCR Test | day 14 | Count (%) of participants with a negative SARS-CoV2 RT-PCR test at day 14 |
| Indicator of SARS-CoV-2 Related Hospitalizations, ED Visits, or Death in Outpatients With COVID-19 Disease. | 28 days | Count (%) of participants that experienced SARS-CoV-2 a related hospitalization, emergency department (ED) visit, or death. |
| Indicator Participant Has Developed Antibodies to SARS-CoV-2 | 28 days | — |
| Time to Full Resolution | 28 days | The number of participants with full resolution by Day 28 is reported. Full resolution is defined as the study day where no symptoms are first self-reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Camostat Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days. | 2 |
| Matching Placebo Participants receive placebo to match camostat for 10 days. | 0 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Camostat | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment United States | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 0 |
| other Total, other adverse events | 0 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
For the Viral Domain: Change in Viral Shedding
The number of participants who had viral shedding at Day 10 is reported. Change in shedding of SARS-CoV-2 virus through day 10 attained from self-collected nasal swab RT-PCR data after transformation using a referenced standard curve.
Time frame: 10 days
Population: No participants were enrolled in the placebo arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Camostat | For the Viral Domain: Change in Viral Shedding | 1 Participants |
Secondary
For Clinical Domain: Time-to-sustained-resolution
The number of participants with sustained resolution by Day 28 is reported. Resolution is defined as the first day where no symptoms are self-reported on all succeeding days through and including day 28, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none.
Time frame: 28 days
Population: No participants were enrolled in the placebo arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Camostat | For Clinical Domain: Time-to-sustained-resolution | 2 Participants |
Secondary
Indicator of SARS-CoV-2 Related Hospitalizations, ED Visits, or Death in Outpatients With COVID-19 Disease.
Count (%) of participants that experienced SARS-CoV-2 a related hospitalization, emergency department (ED) visit, or death.
Time frame: 28 days
Population: No participants were enrolled in the placebo arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Camostat | Indicator of SARS-CoV-2 Related Hospitalizations, ED Visits, or Death in Outpatients With COVID-19 Disease. | 0 Participants |
| Matching Placebo | Indicator of SARS-CoV-2 Related Hospitalizations, ED Visits, or Death in Outpatients With COVID-19 Disease. | 0 Participants |
Secondary
Indicator Participant Has a Negative SARS-CoV2 RT-PCR Test
Count (%) of participants with a negative SARS-CoV2 RT-PCR test at day 28
Time frame: day 28
Population: Participants with data collected. No participants were enrolled in the placebo arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Camostat | Indicator Participant Has a Negative SARS-CoV2 RT-PCR Test | 1 Participants |
Secondary
Indicator Participant Has a Negative SARS-CoV2 RT-PCR Test
Count (%) of participants with a negative SARS-CoV2 RT-PCR test at day 14
Time frame: day 14
Population: Participants with data collected. No participants were enrolled in the placebo arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Camostat | Indicator Participant Has a Negative SARS-CoV2 RT-PCR Test | 1 Participants |
Secondary
Indicator Participant Has Developed Antibodies to SARS-CoV-2
Time frame: 28 days
Population: No antibody results data were collected in the camostat arm, and no participants were enrolled in the placebo arm.
Secondary
Time to First Resolution
The number of participants with first resolution by Day 28 is reported. First resolution is defined as the first study day where no symptoms are self-reported, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none.
Time frame: 28 days
Population: No participants were enrolled in the placebo arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Camostat | Time to First Resolution | 2 Participants |
Secondary
Time to Full Resolution
The number of participants with full resolution by Day 28 is reported. Full resolution is defined as the study day where no symptoms are first self-reported.
Time frame: 28 days
Population: No participants were enrolled in the placebo arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Camostat | Time to Full Resolution | 2 Participants |
Secondary
Time to Viral Cessation
Defined as the time in days from randomization to the first of two consecutive negative RT-PCR results of self-collected nasal swabs.
Time frame: 28 days
Population: No participants were enrolled in the placebo arm..
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Camostat | Time to Viral Cessation | NA days |