A Phase 2 interventional study of Merimepodib and Matching Placebo in COVID-19, sponsored by ViralClear Pharmaceuticals, Inc.. Terminated at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by ViralClear Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 44 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with ViralClear Pharmaceuticals, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Drug: Merimepodib · Drug: Remdesivir
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).
Drug: Matching Placebo · Drug: Remdesivir
400 mg (total daily dose of 1200 mg) for 10 days
Also known as: VX-497
0 mg (total daily dose of 0 mg) for 10 days
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)
Number of subjects not hospitalized or, if hospitalized, free of respiratory failure
Proportion of subjects alive at Day 28 who are not hospitalized or if hospitalized are free of respiratory failure
Time frame: Day 0 to Day 28
Adverse Events
Number of Adverse Events (AEs) and number \& percentage of subjects experiencing AEs after administration of the first dose of study drug
Time frame: Day 0 to Day 56
National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale
Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities
Time frame: Day 0 to Day 28
Temperature
Duration of fever
Time frame: Day 0 to Day 37
Death
Number of deaths
Time frame: Day 0 to Day 56
Mechanical ventilation
Need and duration of mechanical ventilation
Time frame: Day 0 to Day 56
Vasopressor Support
Duration of vasopressor support
Time frame: Day 0 to Day 56
Oxygen Therapy
Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula
Time frame: Day 0 to Day 37
Cessation of Viral Shedding
Time to cessation of viral shedding based on absence of SARS-CoV-2 in a PCR based COVID-19 test
Time frame: Day 0 to Day 37
Change in Oxygen Saturation/Fraction of Inspired Oxygen
Change in SpO2/FiO2
Time frame: Day 0 to Day 37
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.