Differential Diagnosis of Persistent COVID-19 by Artificial Intelligence

COVID-19 Clinical Trial

— DICOPERIA  

Official title:

Differential Diagnosis of Persistent COVID-19 by Artificial Intelligence

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05629793
• Other study ID #: DICOPERIA
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 14, 2022
• Est. completion date: November 2023

Study information

• Verified date: November 2022
• Source: Fundacin Biomedica Galicia Sur
• Contact: Alejandro García Caballero, MD
• Phone: 988 38 55 00
• Email: alejandro.alberto.garcia.caballero[@]sergas.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Persistent COVID group:

Inclusion Criteria:

• Age =18 and =70 years of age
• Confirmed infection (PCR) with SARS- CoV-2 until 03/28/2022 and thereafter date.
• Symptoms include: fatigue, respiratory distress or cognitive dysfunction, among others.
• Symptoms persist or appear more than 3 months after onset of infection.
• Symptoms last longer than 2 months and are not better explained by another diagnosis.
• Symptoms appeared after initial recovery or persisted since disease debut.
• Symptoms may fluctuate or remit over time.
• Patients have capacity to consent and agree to participate in the study.

Exclusion Criteria:

• Active COVID-19 infection.
• Cardiac arrhythmia, pacemaker carrier.
• Other pathologies with dysautonomia.
• Raynaud's phenomenon.
• Other diseases that may affect exercise capacity or be aggravated by exercise shall also be excluded, such as: Uncontrolled heart failure, severe or symptomatic aortic stenosis, pulmonary edema, acute respiratory failure, recent pulmonary thromboembolism, lower limb thrombosis, infections, thyrotoxicosis, or orthopedic inability to walk. Recovery COVID group

Inclusion Criteria:

• Age =18 and =70 years of age
• Confirmed infection (PCR) with SARS- CoV-2 until 03/28/2022 and thereafter date.
• Full functional recovery.
• Follow-up by Primary Care.
• They have not presented three months after the onset of the disease: fatigue, respiratory distress or cognitive dysfunction, among others.
• Patients have capacity to consent and agree to participate in the study.

Exclusion Criteria:

• Active COVID-19 infection.
• Cardiac arrhythmia, pacemaker carrier.
• Other pathologies with dysautonomia.
• Raynaud's phenomenon.
• Other diseases that may affect exercise capacity or be aggravated by exercise such as:

uncontrolled heart failure, severe or symptomatic aortic stenosis, pulmonary edema, acute respiratory failure, recent pulmonary thromboembolism, lower limb thrombosis, infections, thyrotoxicosis, or orthopedic inability to walk shall also be excluded.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• COVID-19
• Distress Respiratory Syndrome
• Fatigue
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario de Ourense	Ourense
Spain	Health Center A Cuña	Ourense
Spain	Health Center Novoa Santos	Ourense
Spain	Health Center Valle Inclán	Ourense
Spain	S.S. Computer Engineering (University of Vigo)	Ourense
Spain	Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro	Vigo
Spain	School of Telecommunication Engineering (University of Vigo)	Vigo

Sponsors (3)

Lead Sponsor	Collaborator
Fundacin Biomedica Galicia Sur	Galician South Health Research Institute, University of Vigo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Years	8 weeks
Other	Sex	Male, Female	8 weeks
Other	Current treatment	Treatment taken by the patient at the time of the study.	8 weeks
Other	Date of PCR + SARS-CoV-2	DD-MMM-YYYY	8 weeks
Other	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
Other	Vaccination status at the time of infection	Number of vaccines doses at the time of infection	8 weeks
Other	FVC	Is the maximum volume of air exhaled, with the maximum possible effort, starting from a maximum inspiration in ml.	8 weeks
Other	FEV1	The volume of air expelled during the first second of forced expiration in ml.	8 weeks
Other	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
Other	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	6MWT	metres/min. The patient will walk the maximum distance they can in 6 minutes.	8 weeks
Secondary	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
Secondary	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