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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Drug: Niclosamide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UNI91103 intranasal spray 1%<br>UNI91103 intranasal spray 1%, BID, 10 consecutive days | Drug: Niclosamide<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo intranasal spray, BID, 10 consecutive days | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Proportion of subjects who are asymptomatic on Day 10 | Assessed by the FDA COVID-19 symptom questionnaire | Day 10 | 
| 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 | 
| 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 | 
| 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 |