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

Phase 2

Terminated

• Conditions: COVID-19
• Interventions: Drug: Matching Placebo; Drug: Merimepodib; Drug: Remdesivir

• Registration Number: NCT04410354
• Lead Sponsor: ViralClear Pharmaceuticals, Inc.

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 Timeline

• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-01
• Study Start: 2020-06-16
• Status Verified: 2020-12
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMPD + remdesivir	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).
Placebo + remdesivir	Matching Placebo	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).
MMPD + remdesivir	Merimepodib	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).
Placebo + remdesivir	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).

Primary Outcome Measures

Name	Time	Method
Number of subjects not hospitalized or, if hospitalized, free of respiratory failure	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	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

Secondary Outcome Measures

Name	Time	Method
Temperature	Day 0 to Day 37	Duration of fever
National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale	Day 0 to Day 28	Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities
Death	Day 0 to Day 56	Number of deaths
Mechanical ventilation	Day 0 to Day 56	Need and duration of mechanical ventilation
Vasopressor Support	Day 0 to Day 56	Duration of vasopressor support
Change in Oxygen Saturation/Fraction of Inspired Oxygen	Day 0 to Day 37	Change in SpO2/FiO2
Oxygen Therapy	Day 0 to Day 37	Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula
Cessation of Viral Shedding	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

Trial Locations

Locations (10)

Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

HCA Houston Healthcare Medical Center; 🇺🇸 Houston, Texas, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

St. David's South Austin Medical Center; 🇺🇸 Austin, Texas, United States

St. David's Medical Center; 🇺🇸 Austin, Texas, United States

HCA Houston Healthcare Mainland; 🇺🇸 Texas City, Texas, United States

Atlantic Health System / Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States

Atlantic Health System / Overlook Medical Center; 🇺🇸 Summit, New Jersey, United States

Mayo Clinic in Arizona; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States