Differential Diagnosis of Persistent COVID-19 by Artificial Intelligence (NCT05629793) | Clinical Trial Compass
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Differential Diagnosis of Persistent COVID-19 by Artificial Intelligence
Spain136 participantsStarted 2022-12-14
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 an…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.