Clinical trial NCT04410354: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Keywords: Coronavirus
Advanced Coronavirus Disease 2019
SARS-Cov-2
Lead sponsor: ViralClear Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of subjects not hospitalized or, if hospitalized, free of respiratory failure
timeFrame: Day 0 to Day 28
measure: Adverse Events
timeFrame: Day 0 to Day 56
Secondary outcomes:
measure: National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale
timeFrame: Day 0 to Day 28
measure: Temperature
timeFrame: Day 0 to Day 37
measure: Death
timeFrame: Day 0 to Day 56
measure: Mechanical ventilation
timeFrame: Day 0 to Day 56
measure: Vasopressor Support
timeFrame: Day 0 to Day 56
measure: Oxygen Therapy
timeFrame: Day 0 to Day 37
measure: Cessation of Viral Shedding
timeFrame: Day 0 to Day 37
measure: Change in Oxygen Saturation/Fraction of Inspired Oxygen
timeFrame: Day 0 to Day 37
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Morristown
country: United States
facility: Atlantic Health System / Morristown Medical Center
state: New Jersey
city: Summit
country: United States
facility: Atlantic Health System / Overlook Medical Center
state: New Jersey
city: Austin
country: United States
facility: St. David's South Austin Medical Center
state: Texas
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
city: Houston
country: United States
facility: HCA Houston Healthcare Medical Center
state: Texas
city: Texas City
country: United States
facility: HCA Houston Healthcare Mainland
state: Texas
Study officials:
affiliation: Mayo Clinic
name: Andrew Badley, MD
role: STUDY_DIRECTOR
References: