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出境医 / 临床实验 / Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19 (PREVENT)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Niclosamide Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 3, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: UNI91103 intranasal spray 1%
UNI91103 intranasal spray 1%, BID, 10 consecutive days
 Drug: Niclosamide
Niclosamide is a broad spectrum, host targeting antiviral that inhibits viral replication (by neutralizing endosomal pH) and increases viral clearance (by increasing the autophagic flux). The niclosamide solution is administered directly to the nasal cavity via a nasal spray.
Placebo Comparator: Placebo
Placebo intranasal spray, BID, 10 consecutive days
 Drug: Placebo
The placebo formulation contains purified water, sodium chloride as common isotonizing agent and the FAO/WHO approved colorant FD&C Red 40 to match the red-orange colour of the active solution. The solution is administered directly to the nasal cavity via a nasal spray.
Outcome Measures
Primary Outcome Measures :
  1. Proportion of subjects with worsened symptoms any time from Day 3 to Day 10 compared with baseline [ Time Frame: Day 3 to Day 10 ]
    Worsening is assessed by the Food and Drug Administration (FDA) COVID-19 Symptom Questionnaire, assessing severity of symptoms over the past 24 hour period.


Secondary Outcome Measures :
  1. 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 [ Time Frame: Day 10 and up to Day 15 ]
    Assessed by the FDA COVID-19 symptom questionnaire divided into 3 domains - Items 1 to 10, items 11 to 12 and items 13 to 14

  2. Proportion of subjects reporting the following number of symptoms with worst intensity/severe grade: ≥ 1 symptom, ≥ 2 symptoms, ≥ 3 symptoms, etc. [ Time Frame: Any time point ]
    Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms

  3. Proportion of subjects with worsened symptoms at Day 15 compared with baseline. [ Time Frame: Day 15 ]
    Worsening is assessed by the FDA COVID-19 Symptom Questionnaire, which is a self reported questionnaire assessing severity of symptoms over the past 24 hour period.

  4. Change from baseline in each single symptom score [ Time Frame: Days 10, 15 and 30 ]
    Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms

  5. Proportion of subjects who are asymptomatic on Day 10 [ Time Frame: Day 10 ]
    Assessed by the FDA COVID-19 symptom questionnaire

  6. Proportion of subjects requiring visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization because of signs or symptoms of COVID-19 [ Time Frame: Day 10, 15 and 30 ]
    Number of visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization is assessed by a self developed questionnaire

  7. Proportion of subjects admitted to intensive care units (ICU) and/or died [ Time Frame: At screening, Day 1, and every other day through Day 10, and again at Day 15 and Day 30 ]
    Assessed by WHO 11-point Ordinal Scale

  8. Change from baseline in SARS-CoV-2 viral load at Day 5 and Day 10 [ Time Frame: Day 5 and Day 10 ]
    Assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: UNION therapeutics A/S +4561777435 clinicaltrials@uniontherapeutics.com

Locations
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Germany
Klinische Forschung Berlin-Mitte GmbH Recruiting
Berlin, Germany
Contact: Investigator         
Klinische Forschung Dresden GmbH Recruiting
Dresden, Germany
Contact: Investigator         
Klinische Forschung Hamburg GmbH Recruiting
Hamburg, Germany
Contact: Investigator         
Sponsors and Collaborators
UNION therapeutics
Investigators
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Principal Investigator: Peter Heymer, MD Klinische Forschung Dresden GmbH
Tracking Information
First Submitted Date  ICMJE June 18, 2021
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date October 22, 2021
Actual Study Start Date  ICMJE September 3, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2021) 		Proportion of subjects with worsened symptoms any time from Day 3 to Day 10 compared with baseline [ Time Frame: Day 3 to Day 10 ]
Worsening is assessed by the Food and Drug Administration (FDA) COVID-19 Symptom Questionnaire, assessing severity of symptoms over the past 24 hour period.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2021)
  • 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 [ Time Frame: Day 10 and up to Day 15 ]
    Assessed by the FDA COVID-19 symptom questionnaire divided into 3 domains - Items 1 to 10, items 11 to 12 and items 13 to 14
  • Proportion of subjects reporting the following number of symptoms with worst intensity/severe grade: ≥ 1 symptom, ≥ 2 symptoms, ≥ 3 symptoms, etc. [ Time Frame: Any time point ]
    Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms
  • Proportion of subjects with worsened symptoms at Day 15 compared with baseline. [ Time Frame: Day 15 ]
    Worsening is assessed by the FDA COVID-19 Symptom Questionnaire, which is a self reported questionnaire assessing severity of symptoms over the past 24 hour period.
  • Change from baseline in each single symptom score [ Time Frame: Days 10, 15 and 30 ]
    Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms
  • Proportion of subjects who are asymptomatic on Day 10 [ Time Frame: Day 10 ]
    Assessed by the FDA COVID-19 symptom questionnaire
  • Proportion of subjects requiring visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization because of signs or symptoms of COVID-19 [ Time Frame: Day 10, 15 and 30 ]
    Number of visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization is assessed by a self developed questionnaire
  • Proportion of subjects admitted to intensive care units (ICU) and/or died [ Time Frame: At screening, Day 1, and every other day through Day 10, and again at Day 15 and Day 30 ]
    Assessed by WHO 11-point Ordinal Scale
  • Change from baseline in SARS-CoV-2 viral load at Day 5 and Day 10 [ Time Frame: Day 5 and Day 10 ]
    Assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Niclosamide
    Niclosamide is a broad spectrum, host targeting antiviral that inhibits viral replication (by neutralizing endosomal pH) and increases viral clearance (by increasing the autophagic flux). The niclosamide solution is administered directly to the nasal cavity via a nasal spray.
  • Drug: Placebo
    The placebo formulation contains purified water, sodium chloride as common isotonizing agent and the FAO/WHO approved colorant FD&C Red 40 to match the red-orange colour of the active solution. The solution is administered directly to the nasal cavity via a nasal spray.
Study Arms  ICMJE
  • Experimental: UNI91103 intranasal spray 1%
    UNI91103 intranasal spray 1%, BID, 10 consecutive days
    Intervention: Drug: Niclosamide
  • Placebo Comparator: Placebo
    Placebo intranasal spray, BID, 10 consecutive days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2021) 		330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: UNION therapeutics A/S +4561777435 clinicaltrials@uniontherapeutics.com
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04932915
Other Study ID Numbers  ICMJE UNI91103-201
2021-001036-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party UNION therapeutics
Study Sponsor  ICMJE UNION therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Heymer, MD Klinische Forschung Dresden GmbH
PRS Account UNION therapeutics
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP