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

COVID-19 Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04410354
• Other study ID #: VC-02-01
• Status: Terminated
• Phase: Phase 2
• Start date: June 16, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: ViralClear Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Merimepodib
400 mg (total daily dose of 1200 mg) for 10 days
• Matching Placebo
0 mg (total daily dose of 0 mg) for 10 days
• 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)

Locations

Country	Name	City	State
United States	St. David's Medical Center	Austin	Texas
United States	St. David's South Austin Medical Center	Austin	Texas
United States	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	Atlantic Health System / Morristown Medical Center	Morristown	New Jersey
United States	Mayo Clinic in Arizona	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Atlantic Health System / Overlook Medical Center	Summit	New Jersey
United States	HCA Houston Healthcare Mainland	Texas City	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ViralClear Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects not hospitalized or, if hospitalized, free of respiratory failure	Proportion of subjects alive at Day 28 who are not hospitalized or if hospitalized are free of respiratory failure	Day 0 to Day 28
Primary	Adverse Events	Number of Adverse Events (AEs) and number & percentage of subjects experiencing AEs after administration of the first dose of study drug	Day 0 to Day 56
Secondary	National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale	Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities	Day 0 to Day 28
Secondary	Temperature	Duration of fever	Day 0 to Day 37
Secondary	Death	Number of deaths	Day 0 to Day 56
Secondary	Mechanical ventilation	Need and duration of mechanical ventilation	Day 0 to Day 56
Secondary	Vasopressor Support	Duration of vasopressor support	Day 0 to Day 56
Secondary	Oxygen Therapy	Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula	Day 0 to Day 37
Secondary	Cessation of Viral Shedding	Time to cessation of viral shedding based on absence of SARS-CoV-2 in a PCR based COVID-19 test	Day 0 to Day 37
Secondary	Change in Oxygen Saturation/Fraction of Inspired Oxygen	Change in SpO2/FiO2	Day 0 to Day 37