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Trial - NCT05220579


Column Value
Trial registration number NCT05220579
Full text link
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Oleg V Fatenkov, Ph.D, M.D.

Contact
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

2022-02-02

Recruitment status
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 4, 2022, 1:30 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 : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: men and women aged 18 and over, diagnosed with coronavirus infection covid-19 after specific testing. when the course of the disease progressed to a severe degree, patients were excluded from the study; signed consent to participate in the trial; patients hospitalized with covid-19 disease. positive result of a pcr test (biomaterial - a swab from the nasopharynx and / or oropharynx) for infection with the sars-cov-2 virus within 72 hours on the day of screening. patients with characteristic computed tomographic signs of the "ground-glass opacity" (one or two-sided spread) in combination with local foci of consolidation or without them; oxygen therapy is not required, or oxygen therapy is required using a face mask or nasal cannulas; the duration of the disease from the first symptoms to the day of screening is not more than 7 days; the ability to understand the requirements for research participants, to give written consent to participate in the research (including the use and transfer of information about the health of patients, relevant to the research) and to follow the procedures specified in the research protocol.

Exclusion criteria
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

the patient's desire to discontinue participation in the study (withdrawal of informed consent). the decision of the investigating physician that the patient should be excluded for the benefit of the patient him/herself; the patient refuses to cooperate with the investigator or is not disciplined; death of the patient; progressing of the disease to a severe degree.

Number of arms
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Concern GRANIT

Inclusion age min
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Russia

Type of patients
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

236

primary outcome
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Banded neutrophils;Banded neutrophils;Banded neutrophils;PCR;PCR

Notes
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2158, "treatment_name": "Non-invasive electromagnetic therapy", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]