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| Name | Class |
|---|---|
| University of Vigo | OTHER |
| Galician South Health Research Institute | NETWORK |
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The pandemic caused by SARS-CoV-2 infection has resulted, in addition to the well-known acute symptoms, in the emergence of persistent, diffuse and heterogeneous symptoms referred to as persistent COVID.
Common symptoms include fatigue, shortness of breath, and cognitive dysfunction, among others, and result in an impact on daily functioning. Symptoms may be new onset, appear after initial recovery from an acute episode of COVID-19, or persist after the initial illness. Cardiac variability (HRV) was initially used in COVID-19 to predict mortality in the acute setting. Dysautonomia which partly evaluates HRV is frequent in patients with persistent COVID. Several groups have used voice or other respiratory noise analysis for the diagnosis of acute COVID.
Patients in the persistent COVID cohort will be able to be differentiated from an age, sex and vaccination status matched cohort of recovered COVID patients without sequelae by means of a model created by Machine Learning that will be trained using cardiac variability (HRV), skin conductance and acoustic analysis data. The primary objetive will be to obtain a classification algorithm by Machine Learning to differentiate the group of patients with persistent COVID diagnosis from the paired group of recovered COVID patients without sequelae.
This is a validation study of a Machine Learning algorithm for the diagnosis of persistent COVID using clinical diagnosis as the "gold standard". The sample will be composed of post-COVID patients, one group of which developed persistent COVID and another paired with the previous one with cured COVID without sequelae.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persistent COVID group | Experimental | Patients with persistent COVID will be recruited by the physicians of the Post COVID-19 Multidisciplinary Clinic of the Complexo Hospitalario Universitario de Ourense. |
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| Recovered COVID group | Experimental | The controls will be recruited in a matched manner with the clinical sample in age, sex, epidemic wave and vaccination status, from among previously COVID-positive patients cured without sequelae and attended in Primary Care in the Health Centers of A Cuña, Valle Inclán and Novoa Santos in Ourense. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental tests | Other | Walking for 6 minutes, sitting down and getting up from a chair for 1 minute and finally the cold test (Cold pressor) where the hand is introduced for 1 minute in water at 4ºC. The patient will be monitored by means of a Polar H10 chest strap, as used in sports, continuously and 02 saturation, TA and voice (exhalation while saying /a/ and dry cough) will be collected before and after the tests. Finally, skin conductance will be monitored by performing baseline tracing and then control while performing the cold test. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of the group of patients with a persistent diagnosis of COVID from the age-matched group, sex and vaccination status of patients recovered from COVID without sequelae. | Through an algorithm model created by Machine Learning that will be trained using cardic variability (HRV), skin conductance and acoustic analysis data. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac variability | Number of times a contraction of the heart occurs in one minute, expressed in beats per minute, by means of a Polar chest strap, model H10. A baseline recording of 5 minutes duration will be taken, with the patient in a seated position. At the end of each test, recording is continued for 2 minutes to demonstrate the speed and degree of recovery after stress. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Years | 8 weeks |
| Sex | Male, Female | 8 weeks |
Persistent COVID group:
Inclusion Criteria:
Exclusion Criteria:
Recovery COVID group
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandro García Caballero, MD | Contact | 988 38 55 00 | alejandro.alberto.garcia.caballero@sergas.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complexo Hospitalario Universitario de Ourense | Ourense | 32002 | Spain |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D005221 | Fatigue |
| D001261 | Pulmonary Atelectasis |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Persistent COVID group vs. Recovered COVID group
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The investigators performing the tests will be blinded to the diagnostic group.
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| Voice recording | Sounds produced by the patient at rest and after having performed the stress tests. The patient will be asked to take a deep breath and then pronounce the vowel /a/ in a sustained manner, in a comfortable tone and volume (3 times). | 8 weeks |
| Skin conductance | micro Siemens [µS]. By means of the Bitalino electrodermal activity recording system. It will be recorded at rest, during the Cold Pressor test and once it is finished, for at least two minutes, to assess the normalization of the conductivity curve. | 8 weeks |
| 6MWT | metres/min. The patient will walk the maximum distance they can in 6 minutes. | 8 weeks |
| 1minSTST | Number of repetitions performed after sitting down and getting up from a chair without supporting the hands as many times as possible for 1 minute.. | 8 weeks |
| Cold Pressor test | One hand is inserted into a container with water at 4-5ºC for 1 minute. Before and after the test, HRV, BP, and thermal conductance are recorded for 5 and 2 minutes -respectively- while lying supine. | 8 weeks |
| Current treatment |
Treatment taken by the patient at the time of the study. |
| 8 weeks |
| Date of PCR + SARS-CoV-2 | DD-MMM-YYYY | 8 weeks |
| Epidemic wave | Of the 7 waves of COVID-19 that have occurred in Spain, a description will be given of the wave to which the infection of each patient included belonged. First, second, third, fourth, fifth, sixth, seventh, eighth, ninth or tenth wave. | 8 weeks |
| Vaccination status at the time of infection | Number of vaccines doses at the time of infection | 8 weeks |
| FVC | Is the maximum volume of air exhaled, with the maximum possible effort, starting from a maximum inspiration in ml. | 8 weeks |
| FEV1 | The volume of air expelled during the first second of forced expiration in ml. | 8 weeks |
| FEV1/ FVC | Expressed as a percentage (%), it indicates the proportion of the FVC that is expelled during the first second of the forced expiratory maneuver. | 8 weeks |
| CO diffusion test | To evaluate the transfer of oxygen from the alveolar space to the hemoglobin of the erythrocytes contained in the pulmonary capillaries. Effective alveolar-capillary area available for gas transfer in the lung. (%) | 8 weeks |
| Health Center Novoa Santos | Ourense | 32003 | Spain |
| Health Center Valle Inclán | Ourense | 32004 | Spain |
| S.S. Computer Engineering (University of Vigo) | Ourense | 32004 | Spain |
| Health Center A Cuña | Ourense | 32005 | Spain |
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| Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro | Vigo | 36213 | Spain |
| School of Telecommunication Engineering (University of Vigo) | Vigo | 36310 | Spain |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |