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Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19

NCT04932915 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-02-21

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and efficacy of UNI91103 intranasal spray for treatment of coronavirus disease 2019 (COVID-19) in asymptomatic or mildly symptomatic adults.

Conditions

  • Covid19

Interventions

DRUG

Niclosamide

Niclosamide is a broad spectrum, host targeting antiviral that inhibits viral replication (by neutralizing endosomal pH) and increases viral clearance (by increasing the autophagic flux). The niclosamide solution is administered directly to the nasal cavity via a nasal spray.

DRUG

Placebo

The placebo formulation contains purified water, sodium chloride as common isotonizing agent and the FAO/WHO approved colorant FD\&C Red 40 to match the red-orange colour of the active solution. The solution is administered directly to the nasal cavity via a nasal spray.

Sponsors & Collaborators

  • UNION therapeutics

    lead INDUSTRY

Principal Investigators

  • Peter Heymer, MD · Klinische Forschung Dresden GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2022-01-10
Completion
2022-01-10

Countries

  • Germany

Study Locations

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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 NCT04932915 on ClinicalTrials.gov