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

Primary Purpose

Covid19

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Niclosamide

Placebo

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinische Forschung Berlin-Mitte GmbH
Klinische Forschung Dresden GmbH
Klinische Forschung Hamburg GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

UNI91103 intranasal spray 1%

Placebo

Arm Description

UNI91103 intranasal spray 1%, BID, 10 consecutive days

Placebo intranasal spray, BID, 10 consecutive days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Assessed by the FDA COVID-19 symptom questionnaire divided into 3 domains - Items 1 to 10, items 11 to 12 and items 13 to 14

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

Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms

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

Worsening is assessed by the FDA COVID-19 Symptom Questionnaire, which is a self reported questionnaire assessing severity of symptoms over the past 24 hour period.

Change from baseline in each single symptom score

Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms

Proportion of subjects who are asymptomatic on Day 10

Assessed by the FDA COVID-19 symptom questionnaire

Proportion of subjects requiring visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization because of signs or symptoms of COVID-19

Number of visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization is assessed by a self developed questionnaire

Proportion of subjects admitted to intensive care units (ICU) and/or died

Assessed by WHO 11-point Ordinal Scale

Change from baseline in SARS-CoV-2 viral load at Day 5 and Day 10

Assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)

Full Information

NCT ID

NCT04932915

First Posted

June 18, 2021

Last Updated

February 2, 2022

Sponsor

UNION therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04932915

Brief Title

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

Acronym

PREVENT

Official Title

A Randomized Placebo-controlled Phase 2 Study to Assess the Safety and Efficacy of UNI91103 Intranasal Administration in Adults With Asymptomatic or Mildly Symptomatic COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

Failure of recruiting patients

Study Start Date

September 3, 2021 (Actual)

Primary Completion Date

January 10, 2022 (Actual)

Study Completion Date

January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNION therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UNI91103 intranasal spray 1%

Arm Type

Experimental

Arm Description

UNI91103 intranasal spray 1%, BID, 10 consecutive days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo intranasal spray, BID, 10 consecutive days

Intervention Type

Drug

Intervention Name(s)

Niclosamide

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Day 3 to Day 10

Secondary Outcome Measure Information:

Title

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

Description

Assessed by the FDA COVID-19 symptom questionnaire divided into 3 domains - Items 1 to 10, items 11 to 12 and items 13 to 14

Time Frame

Day 10 and up to Day 15

Title

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

Description

Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms

Time Frame

Any time point

Title

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

Description

Worsening is assessed by the FDA COVID-19 Symptom Questionnaire, which is a self reported questionnaire assessing severity of symptoms over the past 24 hour period.

Time Frame

Day 15

Title

Change from baseline in each single symptom score

Description

Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms

Time Frame

Days 10, 15 and 30

Title

Proportion of subjects who are asymptomatic on Day 10

Description

Assessed by the FDA COVID-19 symptom questionnaire

Time Frame

Day 10

Title

Proportion of subjects requiring visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization because of signs or symptoms of COVID-19

Description

Number of visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization is assessed by a self developed questionnaire

Time Frame

Day 10, 15 and 30

Title

Proportion of subjects admitted to intensive care units (ICU) and/or died

Description

Assessed by WHO 11-point Ordinal Scale

Time Frame

At screening, Day 1, and every other day through Day 10, and again at Day 15 and Day 30

Title

Change from baseline in SARS-CoV-2 viral load at Day 5 and Day 10

Description

Assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)

Time Frame

Day 5 and Day 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Heymer, MD

Organizational Affiliation

Klinische Forschung Dresden GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinische Forschung Berlin-Mitte GmbH

City

Berlin

Country

Germany

Facility Name

Klinische Forschung Dresden GmbH

City

Dresden

Country

Germany

Facility Name

Klinische Forschung Hamburg GmbH

City

Hamburg

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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