Covid19Phase 2PREVENTNCT04932915
Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19
A Phase 2 study testing Niclosamide in people with Covid19, run by UNION therapeutics at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- Niclosamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 3 sitesGermany
- Study dates
- 3 Sep 2021to 10 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Germany3 sites
Klinische Forschung Berlin-Mitte GmbH
Berlin
Klinische Forschung Dresden GmbH
Dresden
Klinische Forschung Hamburg GmbH
Hamburg
About this study
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
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.
- Conditions
- Covid19
- Being tested
- Niclosamide, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiclosamideDrug
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| UNI91103 intranasal spray 1% | Experimental | UNI91103 intranasal spray 1%, BID, 10 consecutive days Receives: Drug: Niclosamide |
| Placebo | Placebo comparator | Placebo intranasal spray, BID, 10 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with worsened symptoms any time from Day 3 to Day 10 compared with baseline
Worsening is assessed by the Food and Drug Administration (FDA) COVID-19 Symptom Questionnaire, assessing severity of symptoms over the past 24 hour period.
Measured: Day 3 to Day 10
Secondary outcomes (8)
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
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
Measured: Day 10 and up to Day 15
Proportion of subjects reporting the following number of symptoms with worst intensity/severe grade: ≥ 1 symptom, ≥ 2 symptoms, ≥ 3 symptoms, etc.
Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms
Measured: Any time point
Proportion of subjects with worsened symptoms at Day 15 compared with baseline.
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.
Measured: Day 15
Change from baseline in each single symptom score
Assessed by the FDA COVID-19 symptom questionnaire looking at the individual symptoms
Measured: Days 10, 15 and 30
Proportion of subjects who are asymptomatic on Day 10
Assessed by the FDA COVID-19 symptom questionnaire
Measured: Day 10
Proportion of subjects requiring visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization because of signs or symptoms of COVID-19
Number of visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization is assessed by a self developed questionnaire
Measured: Day 10, 15 and 30
Proportion of subjects admitted to intensive care units (ICU) and/or died
Assessed by WHO 11-point Ordinal Scale
Measured: At screening, Day 1, and every other day through Day 10, and again at Day 15 and Day 30
Change from baseline in SARS-CoV-2 viral load at Day 5 and Day 10
Assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR)
Measured: Day 5 and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start3 Sep 2021
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Why it stopped: Failure of recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNION therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Heymer, MD, Principal investigator, Klinische Forschung Dresden GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932915
- Sponsor's protocol ID
- UNI91103-201
- Other IDs
- 2021-001036-25
- Acronym
- PREVENT
- Status last verified
- Feb 2022
- First submitted
- 18 Jun 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04932915
- Acronym / sponsor ID
- PREVENT / UNI91103-201
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure of recruiting patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- UNION therapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UNI91103 intranasal spray 1% | Experimental | Drug: NiclosamideUNI91103 intranasal spray 1%, BID, 10 consecutive days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo intranasal spray, BID, 10 consecutive days |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiclosamideNiclosamide 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 | UNI91103 intranasal spray 1% |
| PlaceboThe 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. | Drug | Placebo |
Primary outcome
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.
8 secondary outcomes
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
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
Proportion of subjects with worsened symptoms at Day 15 compared with baseline.
Time frame: Day 15
Change from baseline in each single symptom score
Time frame: Days 10, 15 and 30
Proportion of subjects who are asymptomatic on Day 10
Time frame: Day 10
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
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
Change from baseline in SARS-CoV-2 viral load at Day 5 and Day 10
Time frame: Day 5 and Day 10
Results and safety
The study was stopped early (reason given: Failure of recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Heymer, MD principal investigator
Klinische Forschung Dresden GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niclosamide in people with Covid19, run by UNION therapeutics at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Failure of recruiting patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with worsened symptoms any time from Day 3 to Day 10 compared with baseline (time frame: Day 3 to Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.