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

• ClinicalTrials.gov Identifier: NCT04410354
• Recruitment Status: Terminated
• First Posted: June 1, 2020
• Last Update Posted: December 8, 2020
• Sponsor: ViralClear Pharmaceuticals, Inc.
• Information provided by (Responsible Party): ViralClear Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: April 28, 2020
• First Posted Date: June 1, 2020
• Last Update Posted Date: December 8, 2020
• Actual Study Start Date: June 16, 2020
• Actual Primary Completion Date: December 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19
• Official Title: 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 80 adult patients with advanced coronavirus disease 2019 (COVID-19). Approximately 80 patients will be randomized 1:1 to receive oral administration of MMPD + remdesivir or placebo + remdesivir. The first 40 patients will 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; the final 40 patients will have a score of 3 on the NIAID scale.

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: Interventional
• Study Phase: Phase 2

Study Design

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: COVID-19

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 4, 2020): 44
• Original Estimated Enrollment (submitted: May 28, 2020): 40
• Actual Study Completion Date: December 1, 2020
• Actual Primary Completion Date: December 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 (first 40 patients) or score of 3 on NIAID scale (last 40 patient
• 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 (except for remdesivir)
• 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 treatment with remdesivir more than 24 hours prior to the first randomized dose of study drug
• Known hypersensitivity to the inactive ingredients in the study drug (MMPD or placebo) or any ingredient of remdesivir

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04410354
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: ViralClear Pharmaceuticals, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ViralClear Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Andrew Badley, MD; Mayo Clinic

• PRS Account: ViralClear Pharmaceuticals, Inc.
• Verification Date: December 2020