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

Phase 2TerminatedNCT04932915

UNION therapeutics4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Covid19

Interventions

NiclosamideDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Klinische Forschung Berlin-Mitte GmbH

Berlin, Germany

Klinische Forschung Dresden GmbH

Dresden, Germany

Klinische Forschung Hamburg GmbH

Hamburg, Germany

Outcomes

Primary Outcomes

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.

Time frame: Day 3 to Day 10

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: Day 15

Change from baseline in each single symptom score

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

Time frame: Days 10, 15 and 30

Proportion of subjects who are asymptomatic on Day 10

Assessed by the FDA COVID-19 symptom questionnaire

Time frame: Day 10

Data from ClinicalTrials.gov

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