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The Incidence of Pulmonary, Cardiovascular and Renal System Non-communicable Complications Associated With the Post-acute Phase of the Infection by Covid-19

Study acronym: POINT
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv10
  2. Minor Study sites: 7 to 6v9
  3. Minor Site details revised at 1 of 7 sitesv8
  4. Minor Study sites: 6 to 7v7
  5. Minor Site details revised at 1 of 6 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Site details revised at 2 of 6 sitesv5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 15, 2024 to Dec 10, 2024
    • Site details revised at 6 of 6 sites
    v4
  3. Minor Start date: Dec 2, 2024 to Dec 15, 2024v3
  4. Notable Start date: Oct 14, 2024 to Dec 2, 2024
    • Primary and study completion dates: Oct 14, 2027 to Nov 4, 2027
    • Site contacts updated at 1 of 6 sites
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06608849
Lead Sponsor Hellenic Institute for the Study of Sepsis
Conditions
(from sponsor)
Pulmonary Complications, Cardiovascular Complications, Renal Complications, COVID-19
Related terms COVID-19, Noncommunicable Diseases
Enrollment 345 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov