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

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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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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