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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Kyrgyzstan
Study Type
Interventional
Intervention
Passive Microwave Radiometry
Sponsored by
Kyrgyz State Medical Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19 focused on measuring CT - scan, X-Ray, MWR

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Educational - clinical - scientific medical center of KSMA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

COVID - 19 patients

COVID - 19 and pneumonia patients

Health patients

Arm Description

Outcomes

Primary Outcome Measures

Determine sensitivity and specificity of MWR diagnostics of pneumonia in patients with COVID-19. (diagnosed by PCR and CT)

Secondary Outcome Measures

Full Information

First Posted
September 23, 2020
Last Updated
September 28, 2020
Sponsor
Kyrgyz State Medical Academy
Collaborators
University of Edinburgh, International Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04568525
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 25, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyrgyz State Medical Academy
Collaborators
University of Edinburgh, International Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
CT - scan, X-Ray, MWR

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trials
Masking
Participant
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID - 19 patients
Arm Type
Active Comparator
Arm Title
COVID - 19 and pneumonia patients
Arm Type
Active Comparator
Arm Title
Health patients
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Passive Microwave Radiometry
Intervention Description
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
Primary Outcome Measure Information:
Title
Determine sensitivity and specificity of MWR diagnostics of pneumonia in patients with COVID-19. (diagnosed by PCR and CT)
Time Frame
30 days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
50/50
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Educational - clinical - scientific medical center of KSMA
City
Bishkek
State/Province
Chui
ZIP/Postal Code
720020
Country
Kyrgyzstan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32355837
Citation
Sahu KK, Mishra AK, Lal A. Comprehensive update on current outbreak of novel coronavirus infection (2019-nCoV). Ann Transl Med. 2020 Mar;8(6):393. doi: 10.21037/atm.2020.02.92.
Results Reference
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PubMed Identifier
32007145
Citation
Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.
Results Reference
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PubMed Identifier
32171952
Citation
Wu D, Wu T, Liu Q, Yang Z. The SARS-CoV-2 outbreak: What we know. Int J Infect Dis. 2020 May;94:44-48. doi: 10.1016/j.ijid.2020.03.004. Epub 2020 Mar 12.
Results Reference
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PubMed Identifier
32171866
Citation
Liu K, Chen Y, Lin R, Han K. Clinical features of COVID-19 in elderly patients: A comparison with young and middle-aged patients. J Infect. 2020 Jun;80(6):e14-e18. doi: 10.1016/j.jinf.2020.03.005. Epub 2020 Mar 27.
Results Reference
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PubMed Identifier
32386015
Citation
Zhong Z, Hu Y, Yu Q, Li Y, Li P, Huang W, Liu J, Liu J, Xie X, Zhao W. Multistage CT features of coronavirus disease 2019. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2020 Mar 28;45(3):250-256. doi: 10.11817/j.issn.1672-7347.2020.200144. Chinese, English.
Results Reference
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PubMed Identifier
33562419
Citation
Osmonov B, Ovchinnikov L, Galazis C, Emilov B, Karaibragimov M, Seitov M, Vesnin S, Losev A, Levshinskii V, Popov I, Mustafin C, Kasymbekov T, Goryanin I. Passive Microwave Radiometry for the Diagnosis of Coronavirus Disease 2019 Lung Complications in Kyrgyzstan. Diagnostics (Basel). 2021 Feb 7;11(2):259. doi: 10.3390/diagnostics11020259.
Results Reference
derived

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

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