Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus, Advanced Coronavirus Disease 2019, SARS-Cov-2
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
Sites / Locations
- Mayo Clinic in Arizona
- Holy Cross Hospital
- Mayo Clinic in Florida
- Mayo Clinic
- Atlantic Health System / Morristown Medical Center
- Atlantic Health System / Overlook Medical Center
- St. David's South Austin Medical Center
- St. David's Medical Center
- HCA Houston Healthcare Medical Center
- HCA Houston Healthcare Mainland
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
MMPD + remdesivir
Placebo + 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).
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).