Differential Diagnosis of Persistent COVID-19 by Artificial Intelligence (DICOPERIA)

Fundacin Biomedica Galicia Sur

Status: Not yet enrolling

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

Treatments: Other: Experimental tests

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05629793

DICOPERIA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Persistent COVID group

Experimental group

Description:

Patients with persistent COVID will be recruited by the physicians of the Post COVID-19 Multidisciplinary Clinic of the Complexo Hospitalario Universitario de Ourense.

Treatment:

Other: Experimental tests

Recovered COVID group

Experimental group

Description:

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.

Treatment:

Other: Experimental tests