Differential Diagnosis of Persistent COVID-19 by Artificial Intelligence

NCT05629793 | Unknown

• 1 other identifier: DICOPERIA
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

COVID-19; Fatigue; Distress Respiratory Syndrome; Cognitive Dysfunction; COVID-19 Recurrent; SARS CoV 2 Infection

Keywords

Machine learning; Stress test; Cardiac variability; Voice recording; Skin conductance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cardiac variability

  8 weeks

• Voice recording

  8 weeks

• Skin conductance

  8 weeks

• 6MWT

  8 weeks

• 1minSTST

  8 weeks

Other Outcomes (10)

• Age

  8 weeks

• Sex

  8 weeks

• Current treatment

  8 weeks

Study Arms (2)

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.

Other: Experimental tests

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.

Other: Experimental tests

Interventions

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.

Persistent COVID group; Recovered COVID group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Active COVID-19 infection.
• Cardiac arrhythmia, pacemaker carrier.
• Other pathologies with dysautonomia.

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead
• University of Vigo: collaborator
• Galician South Health Research Institute: collaborator

Study Sites (7)

Complexo Hospitalario Universitario de Ourense

Ourense, 32002, Spain

Location

Health Center Novoa Santos

Ourense, 32003, Spain

Location

Health Center Valle Inclán

Ourense, 32004, Spain

Location

S.S. Computer Engineering (University of Vigo)

Ourense, 32004, Spain

Location

Health Center A Cuña

Ourense, 32005, Spain

Location

Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro

Vigo, 36213, Spain

Location

School of Telecommunication Engineering (University of Vigo)

Vigo, 36310, Spain

Location

MeSH Terms

Conditions

COVID-19; Fatigue; Pulmonary Atelectasis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Alejandro García Caballero, MD

CONTACT

988 38 55 00; alejandro.alberto.garcia.caballero@sergas.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators performing the tests will be blinded to the diagnostic group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Persistent COVID group vs. Recovered COVID group

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 29, 2022
• Study Start: December 14, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

ES (7)