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

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

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.

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