More than 660 million cases of COVID-19 have been reported worldwide, with 183 million cases in the EU alone. In several people, after recovery, the effects of the first waves of COVID-19 persisted beyond the acute phase and increased the risk of chronic multiorgan symptoms and disease. Up to 70% of people affected by COVID-19 showed reduced organ function even four months or more after COVID-19 diagnosis. Such a functional decline is associated with an increased risk of the development of non-communicable diseases (NCDs). Thus, there is an essential need for a better knowledge, tools, clinical guidelines and recommendations that it will make it possible to reduce this overrepresentation of NCDs as a consequence of the post-acute phase (PAP) of COVID-19.
The overall concept underpinning "POINT" is to i) build detailed knowledge on the link between the PAP of COVID-19 caused by previous, current, and future SARS-CoV-2 variants in vaccinated and unvaccinated people, and NCDs, ii) identify robust biomarkers and build predictive tools that help early identification and management of risk of NCDs, and iii) develop guidelines and recommendations for all parts of the healthcare value chain, allowing best prevention and care acknowledging vulnerability. The investigators will focus on the NCDs affecting pulmonary, cardiovascular and renal systems.
Adults (18 years or more) of both genders
Negative history of acute COVID-19
Adults (18 years or more) of both genders
History of acute COVID-19 hospitalized or non-hospitalized. All cases appearing from start of the pandemic until the last six months may apply
Any other co-existing disorder generating clinical symptoms
Failure to thrive according to the attending physicians
Pregnancy or lactation
Any other co-existing disorder generating clinical symptoms
POINT will include patients who have participated in the studies ESCAPE, SAVE, SAVE-MORE and SAVE-LONG. For these patients blood samples and clinical data are already available (Baseline - Year 0 from ESCAPE, SAVE \& SAVE-MORE and Year 1 from SAVE-LONG). POINT needs to enroll three groups of patients (selected by the existing biobank mentioned above, based on the inclusion and exclusion study criteria) to cover the magnitude of the spectrum of COVID-19: * Group A (115 Comparators): Comparators without medical history of acute infection by SARS-CoV-2. * Group B (115 with NO dysfunction): Patients fully recovered by acute COVID-19 who did not present any acute organ injury during acute infection by SARS-CoV-2. * Group C (115 with Dysfunctions): Patients who presented signs of lung, heart, and kidney dysfunction during acute infection by SARS-CoV-2.
Other
Cross-sectional
Blood samples
Other interventionBlood sampling for proteomics and transcriptomics, suPAR measurement \& isolation and stimulation of peripheral blood mononuclear cells, eGFR, serum creatinine, cystatin c \& urea
Six-minute walk test, Spirometry, HRCT, Heart ultrasound, Completion of questionnaires of symptoms
Other interventionSpirometry for forced expiratory volume in the first, second, total lung capacity and diffusion capacity of carbon monoxide.
The incidence of any organ dysfunction during the first 48 months among patients of group C compared to group B
This is a composite endpoint which includes the development of chronic failures of at least one of lung, heart and/or kidneys
The incidence of any organ dysfunction during the first 48 months among patients of group C compared to group A.
This is a composite endpoint which includes the development of chronic failures of at least one of lung, heart and/or kidneys.
The incidence of any organ dysfunction during the first 48 months among patients of group B compared to group A.
This is a composite endpoint which includes the development of chronic failures of at least one of lung, heart and/or kidneys.
The incidence of chronic lung failure during the first 48 months among patients of group C compared to group B.
• The incidence of chronic heart failure during the first 48 months among patients of group C compared to group B.
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