Overview
Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19
Status:
Recruiting
Recruiting
Trial end date:
2021-12-30
2021-12-30
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
UNION therapeuticsTreatments:
Niclosamide
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