Covid19 Clinical Trial
Official title:
Microwave Radiation for Early Diagnostics of Pneumonia in Patients With COVID-19
NCT number | NCT04568525 |
Other study ID # | 01-2/141 27 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | August 1, 2020 |
Verified date | September 2020 |
Source | Kyrgyz State Medical Academy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 195 |
Est. completion date | August 1, 2020 |
Est. primary completion date | July 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Kyrgyzstan | Educational - clinical - scientific medical center of KSMA | Bishkek | Chui |
Lead Sponsor | Collaborator |
---|---|
Kyrgyz State Medical Academy | International Medical University, The University of Edinburgh |
Kyrgyzstan,
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. — View 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. — View 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. Review. — View 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. Review. — View 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. English, Chinese. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine sensitivity and specificity of MWR diagnostics of pneumonia in patients with COVID-19. (diagnosed by PCR and CT) | 30 days |
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