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

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ClinicalTrials.gov Identifier: NCT04568525
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
University of Edinburgh
International Medical University
Information provided by (Responsible Party):
Batyr Osmonov, Kyrgyz State Medical Academy

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Covid19 Diagnostic Test: Passive Microwave Radiometry Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trials
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Microwave Radiation for Early Diagnostics of Pneumonia in Patients With COVID-19
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : July 25, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   50/50
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568525


Locations
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Kyrgyzstan
Educational - clinical - scientific medical center of KSMA
Bishkek, Chui, Kyrgyzstan, 720020
Sponsors and Collaborators
Kyrgyz State Medical Academy
University of Edinburgh
International Medical University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Batyr Osmonov, Head of respiratory department, Kyrgyz State Medical Academy
ClinicalTrials.gov Identifier: NCT04568525    
Other Study ID Numbers: 01-2/141 27
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Batyr Osmonov, Kyrgyz State Medical Academy:
CT - scan
X-Ray
MWR
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases