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Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19

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ClinicalTrials.gov Identifier: NCT04410354
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
ViralClear Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 28, 2020
First Posted Date  ICMJE June 1, 2020
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE June 16, 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
  • Number of subjects not hospitalized or, if hospitalized, free of respiratory failure [ Time Frame: Day 0 to Day 28 ]
    Proportion of subjects alive at Day 28 who are not hospitalized or if hospitalized are free of respiratory failure
  • Adverse Events [ Time Frame: Day 0 to Day 56 ]
    Number of Adverse Events (AEs) and number & percentage of subjects experiencing AEs after administration of the first dose of study drug
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
  • National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale [ Time Frame: Day 0 to Day 28 ]
    Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities
  • Temperature [ Time Frame: Day 0 to Day 37 ]
    Duration of fever
  • Death [ Time Frame: Day 0 to Day 56 ]
    Number of deaths
  • Mechanical ventilation [ Time Frame: Day 0 to Day 56 ]
    Need and duration of mechanical ventilation
  • Vasopressor Support [ Time Frame: Day 0 to Day 56 ]
    Duration of vasopressor support
  • Oxygen Therapy [ Time Frame: Day 0 to Day 37 ]
    Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula
  • Cessation of Viral Shedding [ Time Frame: Day 0 to Day 37 ]
    Time to cessation of viral shedding based on absence of SARS-CoV-2 in a PCR based COVID-19 test
  • Change in Oxygen Saturation/Fraction of Inspired Oxygen [ Time Frame: Day 0 to Day 37 ]
    Change in SpO2/FiO2
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
  • National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale [ Time Frame: Day 0 to Day 28 ]
    Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities
  • Temperature [ Time Frame: Day 0 to Day 37 ]
    Duration of fever
  • Death [ Time Frame: Day 0 to Day 56 ]
    Number of deaths
  • Mechanical ventilation [ Time Frame: Day 0 to Day 56 ]
    Need and duration of mechanical ventilation
  • Vasopressor Support [ Time Frame: Day 0 to Day 56 ]
    Duration of vasopressor support
  • Oxygen Therapy [ Time Frame: Day 0 to Day 37 ]
    Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula
  • Cessation of Viral Shedding [ Time Frame: Day 0 to Day 37 ]
    Time to cessation of viral shedding based on absence of SARS-CoV-2 in a PCR based COVID-19 test
  • Change in Oxygen Saturation/Fraction of Inspired Oxygen [ Time Frame: Day 0 to Day 37 ]
    Change in SpO2/FiO2
  • Safety Assessment - physical exam [ Time Frame: Day 0 to Day 37 ]
    Changes observed in the pulmonary system
  • Safety Assessment - ECG [ Time Frame: Day 0 to Day 10 ]
    Changes as assessed by 12-lead ECG
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination With Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)
Brief Summary The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral solution when administered in combination with remdesivir in adult patients with advanced COVID-19.
Detailed Description

This phase 2 randomized, double-blind, placebo-controlled study will enroll approximately 40 adult patients with advanced coronavirus disease 2019 (COVID-19), who have a score of 3 or 4 on the National Institute of Allergy and Infectious Disease (NIAID) 8-point ordinal scale and at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion or symptoms of severe lower respiratory symptoms. Approximately 40 patients will be randomized 1:1 to receive oral administration of MMPD + remdesivir or placebo + remdesivir.

Study subjects will undergo screening evaluations prior to the first dose of study drug. Study drug treatment (MMPD or placebo) will continue for 10 days, unless the patient is discharged from the hospital before completing the 10-day randomized treatment period. Both treatment arms will also receive remdesivir per the Emergency Use Authorization labeling. Evaluations will be performed on Days 0-10 and every day thereafter until the subject no longer requires any form of respiratory support or they reach the last planned day of in-person study assessments and still require respiratory support. The final in-person study evaluations will be performed 4 weeks after completion of study drug (MMPD or placebo) treatment (Day 37). The final study evaluation will be a telephone call on Day 56.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Eligible study subjects will be randomized 1:1 to receive oral administration of study drug or placebo. Both treatment arms will also receive remdesivir.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Pharmacy prepares medications that are coded
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Merimepodib
    400 mg (total daily dose of 1200 mg) for 10 days
    Other Name: VX-497
  • Drug: Matching Placebo
    0 mg (total daily dose of 0 mg) for 10 days
  • Drug: Remdesivir
    200 mg loading dose on Day 0 followed by 100 mg daily dose for 4 days. If a subject does not demonstrate clinical improvement, 100 mg daily dose may be extended for up to 5 additional days (for a total of up to 10 days)
Study Arms  ICMJE
  • Active Comparator: MMPD + remdesivir
    Study subjects will receive MMPD oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days).
    Interventions:
    • Drug: Merimepodib
    • Drug: Remdesivir
  • Placebo Comparator: Placebo + remdesivir
    Study subjects will receive matching placebo oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days).
    Interventions:
    • Drug: Matching Placebo
    • Drug: Remdesivir
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years old
  • Confirmed SARS-CoV-2 viral infection
  • Advanced COVID-19 with score of 3 or 4 on NIAID scale
  • Has at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath, confusion or severe lower respiratory symptoms
  • Off antiviral medications at least 24 hours prior to first dose of study drug
  • Able to provide consent
  • Agree to appropriate methods of contraception

Exclusion Criteria:

  • In critical condition or has ARDS
  • On invasive mechanical ventilation or ECMO
  • Bacterial or fungal infection
  • Pregnant or lactating (women)
  • ALT >5x ULN, bilirubin >2x ULN, INR outside of normal limits at screening
  • eGFR <30 mL/min
  • Clinically relevant serious co-morbid medical conditions
  • Treatment with any immunosuppressive therapy within 30 days prior to screening
  • Treatment with another investigational drug within 30 days or 5 half-lives of drug prior to screening
  • Prior treatment with the study drug (MMPD) or remdesivir
  • Known hypersensitivity to the inactive ingredients in the study drug (MMPD or placebo) or any ingredient of remdesivir
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrew Badley, MD 507-266-1944 badley.andrew@Mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04410354
Other Study ID Numbers  ICMJE VC-02-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ViralClear Pharmaceuticals, Inc.
Study Sponsor  ICMJE ViralClear Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrew Badley, MD Mayo Clinic
PRS Account ViralClear Pharmaceuticals, Inc.
Verification Date June 2020

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