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

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

Tracking Information

• First Submitted Date: September 23, 2020
• First Posted Date: September 29, 2020
• Last Update Posted Date: September 29, 2020
• Actual Study Start Date: July 1, 2020
• Actual Primary Completion Date: July 25, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 28, 2020): Determine sensitivity and specificity of MWR diagnostics of pneumonia in patients with COVID-19. (diagnosed by PCR and CT) [ Time Frame: 30 days ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized clinical trials

Masking: Single (Participant)
Primary Purpose: Diagnostic

• Condition: Covid19

Intervention

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

Study Arms

• Active Comparator: COVID - 19 patients
  Intervention: Diagnostic Test: Passive Microwave Radiometry
• Active Comparator: COVID - 19 and pneumonia patients
  Intervention: Diagnostic Test: Passive Microwave Radiometry
• Active Comparator: Health patients
  Intervention: Diagnostic Test: Passive Microwave Radiometry

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 28, 2020): 195
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 1, 2020
• Actual Primary Completion Date: July 25, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: 50/50

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Kyrgyzstan

Administrative Information

• NCT Number: NCT04568525
• Other Study ID Numbers: 01-2/141 27
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Batyr Osmonov, Kyrgyz State Medical Academy
• Original Responsible Party: Same as current
• Current Study Sponsor: Kyrgyz State Medical Academy
• Original Study Sponsor: Same as current

Collaborators

• University of Edinburgh
• International Medical University

• Investigators: Not Provided
• PRS Account: Kyrgyz State Medical Academy
• Verification Date: September 2020