Status:
TERMINATED
Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19
Lead Sponsor:
ViralClear Pharmaceuticals, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 randomi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04410354
Start Date
June 16 2020
End Date
December 1 2020
Last Update
December 8 2020
Active Locations (10)
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1
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
2
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
3
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
4
Mayo Clinic
Rochester, Minnesota, United States, 55905