Investigating long-term complications of COVID-19 on lungs, heart, and kidneys
A Non-interventional, Prospective, Cross-sectional Study of the Incidence of Pulmonary, Cardiovascular and Renal System Non-communicable Complications Associated With the Post-acute Phase of the Infection by Sars-Cov-2
This study is trying to see if people who had COVID-19 have more problems with their lungs, heart, and kidneys compared to those who didn't have the virus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 345 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hellenic Institute for the Study of Sepsis Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Athens and 5 other locations) |
| Trial ID | NCT06608849 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the incidence of pulmonary, cardiovascular, and renal complications that may arise after the acute phase of COVID-19. It will involve collecting blood samples, conducting physical tests like the six-minute walk test, and utilizing imaging techniques such as HRCT and heart ultrasounds to assess organ function. The study will compare individuals with a history of COVID-19 to those without, focusing on the long-term effects of the virus on organ health. The goal is to gather detailed knowledge that can inform clinical guidelines and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a history of COVID-19 or those without any history of the infection.
Not a fit: Patients currently experiencing overt organ dysfunction or those with other co-existing disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management and prevention strategies for non-communicable diseases associated with post-acute COVID-19.
How similar studies have performed: Other studies have indicated significant long-term health impacts following COVID-19, suggesting that this approach is relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Group A (comparators) 1. Adults (18 years or more) of both genders 2. Negative history of acute COVID-19 Group B (patients with ΝΟ dysfunction) 1. Adults (18 years or more) of both genders 2. History of acute COVID-19 hospitalized or non-hospitalized. All cases appearing from start of the pandemic until the last six months may apply 3. Absence of any current overt organ dysfunction 4. Absence of signs of any organ dysfunction during acute COVID-19 Group C (patients with dysfunctions) 1. Adults (18 years or more) of both genders 2. History of acute COVID-19 hospitalized or non-hospitalized. All cases appearing from start of the pandemic until the last six months may apply 3. Presence of signs of organ dysfunction of the lung, the kidneys or the heart during acute COVID-19 Exclusion Criteria: Group A (comparators) 1. Any other co-existing disorder generating clinical symptoms 2. Failure to thrive according to the attending physicians 3. Pregnancy or lactation Group B (patients with ΝΟ dysfunction) 1. Any other co-existing disorder generating clinical symptoms 2. Failure to thrive according to the attending physicians 3. Pregnancy or lactation Group C (patients with dysfunctions) 1. Any other co-existing disorder generating clinical symptoms 2. Medical history of any of: * stage III or IV chronic obstructive pulmonary disease according to the GOLD criteria * pulmonary fibrosis or pulmonary hypertension * stage IV solid tumour malignancy under chemotherapy or radiotherapy * systemic sclerosis * congestive heart failure * stage II, III or IV dyspnoea according to the New York Heart Association classification before the acute COVID-19 3. Limited chance of survival for at least six months due to co-existing comorbidity(-ies) according to the judgement of the attending physicians 4. Pregnancy or lactation
Where this trial is running
Athens and 5 other locations
- 10th Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases — Athens, Greece (Recruiting)
- 4th Department of Internal Medicine, ATTIKON University General Hospital — Athens, Greece (Recruiting)
- Obstructive Diseases Clinic, Sotiria Athens Hospital of Chest Diseases — Athens, Greece (Recruiting)
- Out-patient department of Infectious Diseases, Sotiria Athens Hospital of Chest Diseases — Athens, Greece (Recruiting)
- 1st Department of Internal Medicine, Thriasio General Hospital of Elefsina — Elefsina, Greece (Recruiting)
- 2nd Department of Internal Medicine, Thriasio General Hospital of Elefsina — Elefsina, Greece (Recruiting)
Study contacts
- Study coordinator: Prof. Evangelos Giamarellos-Bourboulis
- Email: egiamarel@med.uoa.gr
- Phone: 00302105831994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.