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

NCT ID: NCT04410354

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2020-12-01

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.

Conditions

COVID-19

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Merimepodib

Intervention Type: DRUG

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

Remdesivir

Intervention Type: 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)

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).

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DRUG

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

Remdesivir

Intervention Type: 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)

Interventions

Merimepodib

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

Intervention Type: DRUG

Matching Placebo

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

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

VX-497

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ViralClear Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Badley, MD

Role: STUDY_DIRECTOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Phoenix, Arizona, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Atlantic Health System / Morristown Medical Center

Morristown, New Jersey, United States

Atlantic Health System / Overlook Medical Center

Summit, New Jersey, 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 Medical Center

Houston, Texas, United States

HCA Houston Healthcare Mainland

Texas City, Texas, United States

Countries

United States

Other Identifiers

VC-02-01

Identifier Type: -

Identifier Source: org_study_id