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| Column | Value |
|---|---|
| Trial registration number | NCT04932915 |
|
Full text link
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Feb. 22, 2022, 6 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Feb. 22, 2022, 6 p.m. Source : ClinicalTrials.gov |
clinicaltrials@uniontherapeutics.com |
|
Registration date
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
2021-06-21 |
|
Recruitment status
Last imported at : Feb. 22, 2022, 6 p.m. Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
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
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
- 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 |
|
Number of arms
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
UNION therapeutics |
|
Inclusion age min
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
45 |
|
Inclusion age max
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
80 |
|
Countries
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
Germany |
|
Type of patients
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : Feb. 22, 2022, 6 p.m. Source : ClinicalTrials.gov |
4 |
|
primary outcome
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
Proportion of subjects with worsened symptoms any time from Day 3 to Day 10 compared with baseline |
|
Notes
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : June 23, 2021, 1:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 883, "treatment_name": "Niclosamide", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |