COVID-19
Conditions
Keywords
Coronavirus, Advanced Coronavirus Disease 2019, SARS-Cov-2
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.
Interventions
DRUGMerimepodib
400 mg (total daily dose of 1200 mg) for 10 days
DRUGMatching Placebo
0 mg (total daily dose of 0 mg) for 10 days
DRUGRemdesivir
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)
Sponsors
ViralClear Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Pharmacy prepares medications that are coded
Intervention model description
Eligible study subjects will be randomized 1:1 to receive oral administration of study drug or placebo. Both treatment arms will also receive remdesivir.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects not hospitalized or, if hospitalized, free of respiratory failure | Day 0 to Day 28 | Proportion of subjects alive at Day 28 who are not hospitalized or if hospitalized are free of respiratory failure |
| Adverse Events | Day 0 to Day 56 | Number of Adverse Events (AEs) and number & percentage of subjects experiencing AEs after administration of the first dose of study drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | Day 0 to Day 56 | Number of deaths |
| Mechanical ventilation | Day 0 to Day 56 | Need and duration of mechanical ventilation |
| Vasopressor Support | Day 0 to Day 56 | Duration of vasopressor support |
| National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale | Day 0 to Day 28 | Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities |
| Cessation of Viral Shedding | Day 0 to Day 37 | Time to cessation of viral shedding based on absence of SARS-CoV-2 in a PCR based COVID-19 test |
| Change in Oxygen Saturation/Fraction of Inspired Oxygen | Day 0 to Day 37 | Change in SpO2/FiO2 |
| Oxygen Therapy | Day 0 to Day 37 | Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula |
| Temperature | Day 0 to Day 37 | Duration of fever |
Countries
United States
Outcome results
None listed