Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19
- Registration Number
- NCT04932915
- Lead Sponsor
- UNION therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo intranasal spray, BID, 10 consecutive days UNI91103 intranasal spray 1% Niclosamide UNI91103 intranasal spray 1%, BID, 10 consecutive days
- Primary Outcome Measures
Name Time Method Proportion of subjects with worsened symptoms any time from Day 3 to Day 10 compared with baseline Day 3 to Day 10 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
Name Time Method 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 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. Any time point 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. Day 15 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 Days 10, 15 and 30 Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms
Proportion of subjects who are asymptomatic on Day 10 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 Day 10, 15 and 30 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 At screening, Day 1, and every other day through Day 10, and again at Day 15 and Day 30 Assessed by WHO 11-point Ordinal Scale
Change from baseline in SARS-CoV-2 viral load at Day 5 and Day 10 Day 5 and Day 10 Assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)
Trial Locations
- Locations (3)
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Germany
Klinische Forschung Berlin-Mitte GmbH
🇩🇪Berlin, Germany
Klinische Forschung Hamburg GmbH
🇩🇪Hamburg, Germany