Clinical trial NCT04568525: Passive Microwave Radiometry (MWR) and AI for COVID-19 Complications Early Diagnostics of Lungs
Official title: Microwave Radiation for Early Diagnostics of Pneumonia in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: CT - scan
X-Ray
MWR
Lead sponsor: Kyrgyz State Medical Academy
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
name: International Medical University
First posted: 2020-09-29
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trials
Primary purpose: DIAGNOSTIC

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


Eligibility 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

Primary outcomes:
measure: Determine sensitivity and specificity of MWR diagnostics of pneumonia in patients with COVID-19. (diagnosed by PCR and CT)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: Educational - clinical - scientific medical center of KSMA
state: Chui
Study officials:
References:
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