Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19

• Status: Terminated
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ViralClear Pharmaceuticals, Inc.
• Treatments: Remdesivir

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