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.
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.
Drug: Merimepodib
400 mg (total daily dose of 1200 mg) for 10 days
Other Name: VX-497
Drug: Matching Placebo
0 mg (total daily dose of 0 mg) for 10 days
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)
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
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
Andrew Badley, MD, Study Director
Mayo Clinic