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Intravenous Zotatifin in Adults With Mild or Moderate COVID-19

NCT04632381 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-10-05

No results posted yet for this study

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.

Conditions

  • Corona Virus Infection

Interventions

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

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Effector Therapeutics

    lead INDUSTRY

Principal Investigators

  • Douglas Warner, MD · EFFECTOR Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-01-12
Completion
2023-09-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632381 on ClinicalTrials.gov