An interventional study of Experimental tests in COVID-19, Fatigue and Distress Respiratory Syndrome, sponsored by Fundacin Biomedica Galicia Sur. Status unknown at 7 sites in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Fundacin Biomedica Galicia Sur · Not applicable, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 136 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Fundacin Biomedica Galicia Sur is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Persistent COVID group:
Inclusion Criteria:
Exclusion Criteria:
Recovery COVID group
Inclusion Criteria:
Exclusion Criteria:
Patients with persistent COVID will be recruited by the physicians of the Post COVID-19 Multidisciplinary Clinic of the Complexo Hospitalario Universitario de Ourense.
Other: Experimental tests
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.
Other: Experimental tests
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.
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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).
Time frame: 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.
Time frame: 8 weeks
6MWT
metres/min. The patient will walk the maximum distance they can in 6 minutes.
Time frame: 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..
Time frame: 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.
Time frame: 8 weeks
Age
Years
Time frame: 8 weeks
Sex
Male, Female
Time frame: 8 weeks
Current treatment
Treatment taken by the patient at the time of the study.
Time frame: 8 weeks
Date of PCR + SARS-CoV-2
DD-MMM-YYYY
Time frame: 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.
Time frame: 8 weeks
Vaccination status at the time of infection
Number of vaccines doses at the time of infection
Time frame: 8 weeks
FVC
Is the maximum volume of air exhaled, with the maximum possible effort, starting from a maximum inspiration in ml.
Time frame: 8 weeks
FEV1
The volume of air expelled during the first second of forced expiration in ml.
Time frame: 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.
Time frame: 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. (%)
Time frame: 8 weeks
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Fundacin Biomedica Galicia Sur