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

NCT ID: NCT04932915

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2022-01-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

UNI91103 intranasal spray 1%

UNI91103 intranasal spray 1%, BID, 10 consecutive days

Group Type: EXPERIMENTAL

Niclosamide

Intervention Type: 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.

Placebo

Placebo intranasal spray, BID, 10 consecutive days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNION therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Heymer, MD

Role: PRINCIPAL_INVESTIGATOR

Klinische Forschung Dresden GmbH

Locations

Klinische Forschung Dresden GmbH

Dresden, , Germany

Klinische Forschung Hamburg GmbH

Hamburg, , Germany

Klinische Forschung Berlin-Mitte GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

2021-001036-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UNI91103-201

Identifier Type: -

Identifier Source: org_study_id