Status:
COMPLETED
Clinical Trial of a Medical Device "Device for Non-invasive Electromagnetic Therapy "TOR" in the Treatment of COVID-19"
Lead Sponsor:
Concern GRANIT
Collaborating Sponsors:
Samara State Medical University
Conditions:
Coronavirus Infection COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A clinical trial was conducted with human participation in order to assess the safety and efficacy of the medical device "TOR device for non-invasive electromagnetic therapy" when used as an adjunct i...
Detailed Description
This is a research work with the participation of patients to study the effect of low-power electromagnetic radiation with a selected spectrum on infected cells and the SARS-CoV-2 virus itself. In th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2021
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT05220579
Start Date
December 29 2020
End Date
August 12 2021
Last Update
February 2 2022
Active Locations (1)
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1
Concern GRANIT
Moscow, Russia, 119019