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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-08-01

Brief Summary

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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

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trials

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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COVID - 19 patients

Group Type ACTIVE_COMPARATOR

Passive Microwave Radiometry

Intervention Type DIAGNOSTIC_TEST

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

COVID - 19 and pneumonia patients

Group Type ACTIVE_COMPARATOR

Passive Microwave Radiometry

Intervention Type DIAGNOSTIC_TEST

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

Health patients

Group Type ACTIVE_COMPARATOR

Passive Microwave Radiometry

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No