Clinical trial NCT04932915: Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: UNION therapeutics
Sponsor class: INDUSTRY
First posted: 2021-06-21
Enrollment: 4
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of subjects with worsened symptoms any time from Day 3 to Day 10 compared with baseline
timeFrame: Day 3 to Day 10
Secondary outcomes:
measure: 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
timeFrame: Day 10 and up to Day 15
measure: Proportion of subjects reporting the following number of symptoms with worst intensity/severe grade: ≥ 1 symptom, ≥ 2 symptoms, ≥ 3 symptoms, etc.
timeFrame: Any time point
measure: Proportion of subjects with worsened symptoms at Day 15 compared with baseline.
timeFrame: Day 15
measure: Change from baseline in each single symptom score
timeFrame: Days 10, 15 and 30
measure: Proportion of subjects who are asymptomatic on Day 10
timeFrame: Day 10
measure: Proportion of subjects requiring visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization because of signs or symptoms of COVID-19
timeFrame: Day 10, 15 and 30
measure: Proportion of subjects admitted to intensive care units (ICU) and/or died
timeFrame: At screening, Day 1, and every other day through Day 10, and again at Day 15 and Day 30
measure: Change from baseline in SARS-CoV-2 viral load at Day 5 and Day 10
timeFrame: Day 5 and Day 10
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
Study officials:
affiliation: Klinische Forschung Dresden GmbH
name: Peter Heymer, MD
role: PRINCIPAL_INVESTIGATOR
References: