v3.0.7
Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04357990 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-22 |
|
Recruitment status
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - ≥18 years of age - positive for sars-cov-2 infection - has symptoms of upper respiratory infection - willing to participate in the clinical trial and gives consent - is not pregnant, nor actively trying to conceive a child. |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- under 18 years of age - negative for sars-cov-2 infection - severe symptoms of infection - symptoms involving the entire respiratory system, including pneumonia - requires hospitalisation prior to study start - asymptomatic - pregnant or actively trying to conceive a child - other comorbidities that would prevent administration of the device - requirement to take regular medications administered by inhalation, or via the naso- and oropharyngeal route - patients with known allergies to neem or hypericum oil - patients with asthma |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Kerecis Ltd. |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Iceland |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
|
Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
128 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Number of days until complete resolution of symptoms per group;Number of hospital admissions per group |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Oral and nasal spray", "treatment_id": 1852, "treatment_name": "Viruxal", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |