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COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Camostat Sub-Protocol (COPPS)

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ClinicalTrials.gov Identifier: NCT04662073
Recruitment Status : Enrolling by invitation
First Posted : December 10, 2020
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE December 8, 2020
First Posted Date  ICMJE December 10, 2020
Last Update Posted Date April 13, 2021
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2021)
For the Viral Domain: Change in Viral Shedding [ Time Frame: 10 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2020)
  • For Viral Domain:Time until cessation of shedding of SARS-CoV-2 virus [ Time Frame: 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
  • For Clinical Domain: Time from randomization to sustained symptom resolution assessed over a 28-day period [ Time Frame: 28 days ]
    Resolution is defined as the first study day where no symptoms are self-reported for 48 hours, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none. Participants who never experienced resolution will be censored at their last survey completion day.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2021)
  • For Clinical Domain: Time-to-sustained-resolution [ Time Frame: 28 days ]
    Time from randomization to sustained symptom resolution assessed over a 28-day period. 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 [ Time Frame: 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 [ Time Frame: 28 days ]
    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 to full resolution [ Time Frame: 28 days ]
    Defined as the study day where no symptoms are first self-reported.
  • Indicator of SARS-CoV-2 related hospitalizations, ED visits, or death in outpatients with COVID-19 disease. [ Time Frame: 28 days ]
  • Indicator participant has developed antibodies to SARS-CoV-2 [ Time Frame: 28 days ]
  • Indicator participant has a negative SARS-CoV2 RT-PCR test [ Time Frame: day 14 ]
  • Indicator participant has a negative SARS-CoV2 RT-PCR test [ Time Frame: day 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2020)
  • Time to first resolution [ Time Frame: 28 days ]
    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 of SARS-CoV-2 related hospitalizations, ED visits, or death in outpatients with COVID-19 disease. [ Time Frame: 28 days ]
  • Indicator participant has developed antibodies to SARS-CoV-2 [ Time Frame: 28 days ]
  • Time to event from randomization to worsening of symptoms or disease progression [ Time Frame: 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Camostat Sub-Protocol
Official Title  ICMJE COVID-19 Outpatient Pragmatic Platform Study (COPPS): A Pragmatic Multi-arm, Adaptive, Phase 2, Blinded, Randomized Placebo-controlled Platform Trial to Assess the Efficacy of Different Investigational Therapeutics in Reducing Time to Disease Resolution or Viral Load Cessation, as Compared to Standard Supportive Care in Outpatients With COVID-19
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Camostat
    200-mg tablet administered orally four times daily
  • Drug: Placebo
    Placebo to match camostat administered orally four times daily
Study Arms  ICMJE
  • Experimental: Camostat
    Participants are randomized to receive camostat.
    Intervention: Drug: Camostat
  • Placebo Comparator: Matching Placebo
    Participants are randomized to receive placebo to match camostat.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: December 9, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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.

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 drugs that may be active against COVID-19 in the eyes of the investigators.
  3. Participant has been vaccinated against COVID-19 prior to their positive test result.
  4. Participant yields a positive urine pregnancy test at screening.
  5. 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.
  6. 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).
  7. Has renal insufficiency including severe renal impairment and ESRD and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
  8. Has liver impairment greater than Child Pugh A.
  9. Has a history of alcohol or drug abuse in the previous 6 months.
  10. Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
  11. Has taken another investigational drug within the past 30 days.
  12. Is deemed by the Investigator to be ineligible for any reason.

Additional exclusion criteria for camostat protocol:

  1. Participant has a history of gout and coagulation disorders.
  2. Participant has a concomitant bacterial respiratory infection as documented by a respiratory culture with microbiologic growth. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study.
  3. Has previously received camostat mesilate within the past 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04662073
Other Study ID Numbers  ICMJE COPPS-Camostat
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie Parsonnet, MD Stanford University
Principal Investigator: Chaitan Khosla, PhD Stanford University
PRS Account Stanford University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP