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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04410354

Run by

ViralClear Pharmaceuticals, Inc.

People needed

44

Starts

2020-06-16

Expected to finish

2020-12-01

Last updated by the study team

2020-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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