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

UNION Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Covid19

Treatments: Drug: Niclosamide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04932915

2021-001036-25 (EudraCT Number)

UNI91103-201

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

4 participants in 2 patient groups, including a placebo group

UNI91103 intranasal spray 1%

Experimental group

Description:

UNI91103 intranasal spray 1%, BID, 10 consecutive days

Treatment:

Drug: Niclosamide

Placebo

Placebo Comparator group

Description:

Placebo intranasal spray, BID, 10 consecutive days

Treatment:

Drug: Placebo