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| Column | Value |
|---|---|
| Trial registration number | NCT05054114 |
|
Full text link
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
2021-09-23 |
|
Recruitment status
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - volunteers of both sexes over 18 years of age. - obtaining written informed consent. - ability and consent to participate in this research. - absence of symptoms of respiratory infection. - a negative result of a pcr study for the presence of rna sars-cov-2 according to biomaterial obtained by nasopharyngeal smear. |
|
Exclusion criteria
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
- any other concomitant diseases or conditions, which, in the opinion of the research doctor, may distort research results, restrict the rights of a volunteer or put him/her at greater risk. - contraindications to the use of the investigated medicinal product. - individual intolerance to the ingredients included in the composition of the investigational medicinal product. - pregnancy or breastfeeding. - doubtful result of a pcr test for the presence of rna sars-cov-2 in the biomaterial obtained by nasopharyngeal smear. - participation in a clinical trial using study therapy within 30 days prior to enrollment in this study. - disagreement to follow in the research reliable contraceptive measures (abstinence; or a combination of 2 different methods: for example, barrier and spermicides, or barrier and intrauterine device, or barrier and hormonal, etc.) - for participants with saved reproductive potential. |
|
Number of arms
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
SPP Pharmaclon Ltd. |
|
Inclusion age min
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
Russia |
|
Type of patients
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
630 |
|
primary outcome
Last imported at : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
The proportion of patients with acute respiratory viral infections, including COVID-19, at the end of the prophylactic period |
|
Notes
Last imported at : Sept. 27, 2021, 7:30 a.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 : Sept. 27, 2021, 7:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 673, "treatment_name": "Interferon gamma", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |