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| Column | Value |
|---|---|
| Trial registration number | NCT05135546 |
|
Full text link
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Nov. 30, 2021, 11 p.m. Source : ClinicalTrials.gov |
2021-11-26 |
|
Recruitment status
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Sequential assignment |
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Masking
Last imported at : Nov. 29, 2021, 10:30 p.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 : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: men and women aged 18 and over clinical status according to the who scale - 6, 7, 8 and 9 points. verified respiratory infection covid-19 by real-time pcr (quantitative) patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after: women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year); men using barrier contraception. the study may also involve men who are not fertile (documented conditions: vasectomy, infertility) availability of signed and dated informed consent of the patient to participate in the study. |
|
Exclusion criteria
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
clinical status according to the who scale - 1, 2, 3, 4 and 5 points. increased risk of bleeding: extensive bleeding at the present time; intracranial (including subarachnoid) hemorrhage at the present time. lactation, pregnancy known hypersensitivity to fortelyzin®. |
|
Number of arms
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Supergene, LLC |
|
Inclusion age min
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Russia |
|
Type of patients
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Severe/critical disease at enrollment |
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Severity scale
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
7: Severe/critical disease at enrollment |
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Total sample size
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
4 |
|
primary outcome
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
Number of patients discharged from the hospital with clinical status according to the WHO Ordinal Scale For Clinical Improvement - 3 points or less |
|
Notes
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 2070, "treatment_name": "Recombinant nonimmunogenic staphylokinase", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |