v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
Column | Value |
---|---|
Trial registration number | NCT05069649 |
Full text link
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
|
First author
Last imported at : April 23, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : April 23, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
not reported |
Registration date
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
2021-10-06 |
Recruitment status
Last imported at : April 23, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Completed |
Study design
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
Parallel |
Masking
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
Blind label |
Center
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
multi-center |
Study aim
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
Prevention |
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: adults of either gender aged ≥18 years. participant has not had covid-19 in the previous 6 months. the participant has not been vaccinated against covid-19 or other viral infections in the previous 6 months. negative rapid test result for sars-cov-2 (covid-19 ag). absence of clinical manifestations of any infectious disease, but not earlier than 14 days from its onset. consent to use reliable contraceptive methods during the study (for men and women with reproductive potential). presence of a signed information sheet and informed consent form for participation in a clinical trial. |
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
the presence of contraindications to vaccination: hypersensitivity to any component of the vaccine or a vaccine containing similar components; prior history of severe allergic reactions; acute infectious and non-infectious diseases, exacerbation of chronic diseases. severe chronic hepatic and renal disorders, severe thyroid dysfunction, decompensated diabetes mellitus, severe disorders of the hematopoietic system, epilepsy and other cns diseases, acute coronary syndrome, acute cerebrovascular accident, myocarditis, endocarditis, pericarditis, autoimmune diseases, or immunodeficiency. malabsorption syndrome, including congenital or acquired lactase deficiency or any other disaccharidase deficiency, galactosemia. hypersensitivity to any of the components of study drug used in the treatment. pregnancy, breast-feeding, childbirth less than 3 months before study enrollment. participants who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures. inability to observe the participant during the study period. prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures. participation in other clinical studies within 3 months prior to enrollment in the study. use of any medications listed in "prohibited concomitant treatment" within 4 weeks before enrollment. participants who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. "immediate relative" means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted). participants who work for ooo "npf "materia medica holding" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned). |
Number of arms
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
Materia Medica Holding |
Inclusion age min
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
75 |
Countries
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
Russia |
Type of patients
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
Healthy volunteers |
Severity scale
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
N/A |
Total sample size
Last imported at : April 23, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
1057 |
primary outcome
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
The number of laboratory-confirmed SARS-CoV-2 infections. |
Notes
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
Phase 3 |
Arms
Last imported at : Oct. 7, 2021, noon Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1948, "treatment_name": "Ergoferon", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |