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

Covid19 Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04932915
• Other study ID #: UNI91103-201
• Secondary ID: 2021-001036-25
• Status: Terminated
• Phase: Phase 2
• Start date: September 3, 2021
• Est. completion date: January 10, 2022

Study information

• Verified date: February 2022
• Source: UNION therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Klinische Forschung Dresden GmbH	Dresden
Germany	Klinische Forschung Hamburg GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
UNION therapeutics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Day 10 and up to Day 15
Secondary	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	Any time point
Secondary	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.	Day 15
Secondary	Change from baseline in each single symptom score	Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms	Days 10, 15 and 30
Secondary	Proportion of subjects who are asymptomatic on Day 10	Assessed by the FDA COVID-19 symptom questionnaire	Day 10
Secondary	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	Day 10, 15 and 30
Secondary	Proportion of subjects admitted to intensive care units (ICU) and/or died	Assessed by WHO 11-point Ordinal Scale	At screening, Day 1, and every other day through Day 10, and again at Day 15 and Day 30
Secondary	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)	Day 5 and Day 10