Passive Microwave Radiometry (MWR) and AI for COVID-19 Complications Early Diagnostics of Lungs

September 28, 2020 updated by: Batyr Osmonov, Kyrgyz State Medical Academy

Microwave Radiation for Early Diagnostics of Pneumonia in Patients With COVID-19

World Health Organization (WHO) declared COVID-19 it as a global pandemic. It becomes clear that the virus spreading mostly deadly due to limited to access to diagnostics tests and equipment. Traditional radiography and CT remain the main methods of the initial examination of the chest organs. Now, most of the diagnostics has been focused on PCR, chest x-Ray/CT manifestations of COVID-19. However, there are problems with CT due to infection control issues, the inefficiencies introduced in CT room decontamination, and lack of CT availability in LMIC (Low Middle Income Countries). Passive microwave radiometry (MWR) is a cheap, non-radioactive and portable technology. It has already been used for diagnostics of cancer, and other diseases. The investigators have tested if MWR could be used for early diagnostics of pulmonary COVID-19 complications.

This was a randomized controlled trial (195 subjects) to evaluate the effectiveness of diagnostics using MWR in patients with pneumonia caused by COVID-19 while they are in hospitals of Kyrgyzstan, and healthy individuals.

The investigator have measured skin (IR) and internal (MWR) temperature by recording passive electromagnetic radiation through the chest wall in the projection of the lungs at 30 symmetrical points on both sides. Pneumonia and lung damage were diagnosed by X-RAY/CT scan and doctor's final diagnosis (pn+/pn-). COVID-19 was determined by PCR test (covid+/covid-).

Overall, the study suggests that the use of MWR is a convenient and safe method for screening diagnostics in COVID-19 patients with suspected pneumonia. Since MWR is an inexpensive, it will ease the financial burden for both patients and the countries, especially in LMIC

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kyrgyzstan
    • Chui
      • Bishkek, Chui, Kyrgyzstan, 720020
        • Educational - clinical - scientific medical center of KSMA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female gender, age 18-75 years
  • Positive RT-PCR result of COVID-19
  • Place of birth and residence (<800m above sea level)
  • Informed consent

Exclusion Criteria:

  • - Lack of fever in a healthy group
  • Exacerbation of COPD, very severe COPD with hypoxia (FEV1 <40%, saturation <92% at an altitude of 760 m).
  • Co-morbidities, such as cardiovascular diseases, i.e. unstable systemic arterial hypertension, coronary heart disease; stroke; sleep apnea; pneumothorax last 2 months.
  • Neurological, rheumatological or psychiatric illnesses, including excessive smoking (> 20 cigarettes per day)
  • Kidney failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: COVID - 19 patients
Diagnostic test: Passive Microwave Radiometry
The MWR2020 (ormer RTM-01-RES) device is a unique commercially available CE marked device. It is registered in UK MHRA MDN 40802 as Microwave thermography system for clinical studies. The device is already registered in Kyrgyzstan for breast cancer diagnostics. During the 1980-90s there were several works on identification of excess of microwave emission due to fluid in lungs (on phantoms) which could be indication of inflammatory, process, cancer and other lung disorders.Later results were confirmed by clinical studies for lung cancer
ACTIVE_COMPARATOR: COVID - 19 and pneumonia patients
Diagnostic test: Passive Microwave Radiometry
The MWR2020 (ormer RTM-01-RES) device is a unique commercially available CE marked device. It is registered in UK MHRA MDN 40802 as Microwave thermography system for clinical studies. The device is already registered in Kyrgyzstan for breast cancer diagnostics. During the 1980-90s there were several works on identification of excess of microwave emission due to fluid in lungs (on phantoms) which could be indication of inflammatory, process, cancer and other lung disorders.Later results were confirmed by clinical studies for lung cancer
ACTIVE_COMPARATOR: Health patients
Diagnostic test: Passive Microwave Radiometry
The MWR2020 (ormer RTM-01-RES) device is a unique commercially available CE marked device. It is registered in UK MHRA MDN 40802 as Microwave thermography system for clinical studies. The device is already registered in Kyrgyzstan for breast cancer diagnostics. During the 1980-90s there were several works on identification of excess of microwave emission due to fluid in lungs (on phantoms) which could be indication of inflammatory, process, cancer and other lung disorders.Later results were confirmed by clinical studies for lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine sensitivity and specificity of MWR diagnostics of pneumonia in patients with COVID-19. (diagnosed by PCR and CT)
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyrgyz State Medical Academy

Collaborators

University of Edinburgh
International Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2020

Primary Completion (ACTUAL)

July 25, 2020

Study Completion (ACTUAL)

August 1, 2020

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (ACTUAL)

September 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-2/141 27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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