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

NCT04410354 | Terminated Phase 2 FDA Drug

• 1 other identifier: VC-02-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 10

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.

Conditions

COVID-19

Keywords

Coronavirus; Advanced Coronavirus Disease 2019; SARS-Cov-2

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale

  Day 0 to Day 28

• Temperature

  Day 0 to Day 37

• Death

  Day 0 to Day 56

• Mechanical ventilation

  Day 0 to Day 56

• Vasopressor Support

  Day 0 to Day 56

Study Arms (2)

MMPD + remdesivir

ACTIVE COMPARATOR

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).

Drug: Merimepodib; Drug: Remdesivir

Placebo + remdesivir

PLACEBO COMPARATOR

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).

Drug: Matching Placebo; Drug: Remdesivir

Interventions

Merimepodib DRUG

400 mg (total daily dose of 1200 mg) for 10 days

Also known as: VX-497

MMPD + remdesivir

Matching Placebo DRUG

0 mg (total daily dose of 0 mg) for 10 days

Placebo + remdesivir

Remdesivir DRUG

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)

MMPD + remdesivir; Placebo + remdesivir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ViralClear Pharmaceuticals, Inc.: lead

Study Sites (10)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Atlantic Health System / Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Atlantic Health System / Overlook Medical Center

Summit, New Jersey, 07901, United States

Location

St. David's South Austin Medical Center

Austin, Texas, 78704, United States

Location

St. David's Medical Center

Austin, Texas, 78705, United States

Location

HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States

Location

HCA Houston Healthcare Mainland

Texas City, Texas, 77591, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

N-3-(3-(3-methoxy-4-oxazol-5-ylphenyl)ureido)benzylcarbamic acid tetrahydrofuran-3-yl ester; remdesivir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andrew Badley, MD

  Mayo Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Pharmacy prepares medications that are coded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible study subjects will be randomized 1:1 to receive oral administration of study drug or placebo. Both treatment arms will also receive remdesivir.

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: June 1, 2020
• Study Start: June 16, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)