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

NCT04932915 | Terminated Phase 2 DMC

• 2 other identifiers: UNI91103-2012021-001036-25
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with worsened symptoms any time from Day 3 to Day 10 compared with baseline

  Worsening is assessed by the Food and Drug Administration (FDA) COVID-19 Symptom Questionnaire, assessing severity of symptoms over the past 24 hour period.

  Day 3 to Day 10

Secondary Outcomes (8)

• Proportion of subjects with worst intensity/grade up to Day 10 and up to Day 15 in any single symptoms in the 3 domains of the FDA COVID-19 questionnaire

  Day 10 and up to Day 15

• Proportion of subjects reporting the following number of symptoms with worst intensity/severe grade: ≥ 1 symptom, ≥ 2 symptoms, ≥ 3 symptoms, etc.

  Any time point

• Proportion of subjects with worsened symptoms at Day 15 compared with baseline.

  Day 15

• Change from baseline in each single symptom score

  Days 10, 15 and 30

• Proportion of subjects who are asymptomatic on Day 10

  Day 10

Study Arms (2)

UNI91103 intranasal spray 1%

EXPERIMENTAL

UNI91103 intranasal spray 1%, BID, 10 consecutive days

Drug: Niclosamide

Placebo

PLACEBO COMPARATOR

Placebo intranasal spray, BID, 10 consecutive days

Drug: Placebo

Interventions

Niclosamide DRUG

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.

UNI91103 intranasal spray 1%

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female aged ≥45 and \<80 years
• Subject is tested to confirm infection with SARS-CoV-2 on a sample taken within 3 days before randomization
• Subject is either without symptoms or has 1 or more of the following symptoms: Stuffy or runny nose, Sore throat, Loss of taste, Loss of smell, Headache.
• None of the symptoms should have been present \>5 days.

You may not qualify if:

• Subject has an underlying condition that may interfere with intranasal administration of the IMP (e.g., chronic ulcers in the nose).
• Subject has symptoms suggesting engagement of the lower respiratory tract or a systemic engagement
• Subject has an active or acute infection other than SARS-CoV-2
• Subject has another member of the same household recruited to this study

Sponsors & Collaborators

• UNION therapeutics: lead

Study Sites (3)

Klinische Forschung Berlin-Mitte GmbH

Berlin, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, Germany

Location

MeSH Terms

Conditions

COVID-19

Interventions

Niclosamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salicylanilides; Anilides; Amides; Organic Chemicals; Salicylamides; Aniline Compounds; Amines

Study Officials

• Peter Heymer, MD

  Klinische Forschung Dresden GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 21, 2021
• Study Start: September 3, 2021
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)