NCT04632381

Intravenous Zotatifin in Adults With Mild or Moderate COVID-19

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial of Intravenous Zotatifin in Adults With Mild or Moderate Coronavirus Disease 2019 (COVID-19)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Effector Therapeutics · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability, the antiviral activity, and plasma pharmacokinetics (PK) of zotatifin administered intravenously (IV) to adults with mild or moderate COVID-19.

Detailed description

This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety and efficacy of zotatifin administered IV to adults with mild or moderate COVID 19. Patients will be randomized to receive zotatifin or placebo in 3 cohorts of 12 patients each. Cohorts will be sequentially enrolled at progressively higher zotatifin dose levels. Study drug will not be administered to patients who are hospitalized. The second dose of study drug will not be administered should a patient progress from mild or moderate COVID-19 to severe COVID-19 prior to or on Day 8. Patients will assess and record their symptoms daily through Day 22 and at follow up (30 days after last infusion) (or at the early termination visit \[if conducted\]) in a paper patient diary using the WHO 9-point ordinal scale for clinical improvement. Other safety and efficacy measures will be assessed according to the Schedule of Procedures on Days 1, 4, 8, 10, 15 (end of treatment visit), and 22, and at follow up (30 days after last infusion). On non-dosing days, study visits will be conducted as home health visits, except for the follow-up visit, which will be conducted as a telephone visit.

Conditions

• Corona Virus Infection

Interventions

Type	Name	Description
DRUG	Zotatifin	Zotatifin is a potent and sequence-selective inhibitor of eukaryotic translation initiation factor (eIF) 4A1-mediated translation that imparts its regulation through a reversible enhancement of eIF4A1 binding to RNAs (ribonucleic acids) with specific polypurine motifs within the 5'-untranslated region (UTR).
DRUG	Placebo	5% dextrose injection, USP

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-01-12
• Completion: 2023-09-22
• First posted: 2020-11-17
• Last updated: 2023-10-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study