Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608849
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
The Incidence of Pulmonary Cardiovascular and Renal System Non-communicable Complications Associated with the Post-acute Phase of the Infection by Covid-19
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POINT
Brief Summary:
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
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
Detailed Description:
Post-acute phase of COVID and Non-communicable diseases
Following the emergence of SARS-CoV-2 more than 660 million cases of COVID-19 have been reported worldwide with 183 million cases in the EU alone These numbers will continue to grow even after the disease becomes endemic In some 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 This is especially true for individuals aged 65 and older as the risk of NCDs increases with age
Diseases of the pulmonary cardiovascular and renal systems are the three major NCDs carrying the most significant burden for the individual as well as society Studies have documented compromised function of these 3 organ systems in the PAP of COVID-19 in 30-70 of patients regardless of the severity of the acute-phase As homeostasis of these three organs depends on interorgan communication with each other the impact of PAP of COVID-19 on one will impact the others The added stress of the PAP of COVID-19 increases the risk of a higher incidence andor the risk of an accelerated progression of disease
The prevalence and socioeconomic cost of the three NCDs is already extremely high Without a strong focus on minimmising the increased risk of incidence and accelerated progression of the NCDs as a result of the PAP of COVID-19 up to 9 million Europeans may be affected and result in an added direct attributable cost of between 19564 - 31064 per year for each person who develop an NCD
Beyond state of the art pulmonary cardiovascular and renal complications after the PAP of COVID-19
Post-acute COVID-19 and pulmonary complications - Respiratory conditions have been reported as occurring twice as often after severe COVID-19 as in the general population In a study of 135 individuals the incidence of impaired lung diffusing capacity DLCO and persistent lung damage was demonstrated in 30 of patients 12 months after acute COVID-19 In another study of 142 individuals pulmonary abnormalities were observed by CT scans in 54 of individuals a year after acute COVID-19
Post-acute COVID-19 and cardiovascular complications - The PAP of COVID-19 is associated with an increased risk of deep vein thrombosis up to three months after COVID-19 infection pulmonary embolism up to six months and a bleeding event up to two months In a registry study of 153760 individuals with COVID-19 the 12 month period following the acute phase was characterized by an increased risk and an excess disease burden of cardiovascular diseases including heart failure dysrhythmias and stroke The risks were evident regardless of age race sex and other cardiovascular risk factors MRI revealed cardiac impairment in 78 of 100 individuals in the PAP of COVID-19
Post-acute COVID-19 and renal complications - A study of 1733 individuals documented reduced renal function in 35 6 months after the acute phase of COVID-19 and 13 of patients who did not have acute kidney injury AKI during the acute phase showed a disproportionate reduction in renal function during follow-up A study including ampampgt89000 individuals revealed an increased risk of adverse renal outcomes in the PAP of COVID-19
The main unmet needs requiring action at the European level There is an urgent need to enable a better understanding of the causality between PAP of COVID-19 and the increased risk of pulmonary cardiovascular and renal complications and thereby an increased risk of onset of disease or aggravation of existing disease Even though recent studies suggest such a link there is a need for a more nuanced study of the correlation on much larger cohorts to determine the incidence and risk ratio more accurately Furthermore there is a need to compare the outcomes between the early present and potential future strains of SARS-CoV-2 variants responsible for the disease An increased cohort size will also allow a better understanding of the impact of socioeconomic status difference between sexes the compounding effects of genotype pre-existing comorbidities and use of prescription drugs and of differences between the PAP of early strains of SARS-CoV-2 in mostly unvaccinated individuals compared with current strains in mostly vaccinated people As this knowledge is currently incomplete there is an immediate risk that a large part of the European population will not receive optimal and timely care
Thus far investigators have concluded that the functional decline of organs caused by COVID-19 cannot be explained by known risk factors A review of the recent literature suggests that the PAP of COVID-19 is associated with immune dysregulation elevated levels of autoantibodies microbiota disruption and clotting and endothelial abnormalities However the same review also concludes that the current understanding is not sufficient to improve outcomes and calls for additional research This underscores the involvement of unidentified molecular mechanisms responsible for the aetiology A lack of understanding of these inhibits the development of effective biomarkers and drug candidates that allow optimal prediction of the prognosis and treatment of patients following resolution of the initial symptoms of COVID-19
There is an urgent need for updated clinical practice guidelines and new tools to diagnose and prevent the development and aggravation of NCDs caused by the PAP of COVID-19 Currently there are very few clinical guidelines and recommendations related to the PAP of COVID-19 and NCDs in general and there are even fewer clinical guidelines and recommendations that focus on the effects of the PAP of COVID-19 on pulmonary cardiovascular and renal health Modern clinical practice guidelines and recommendations that efficiently bridge the gap between research and current practice are invaluable for securing best quality of care patient outcomes and cost effectiveness Unfortunately the development of a guideline or a recommendation does not necessarily lead to changes in clinical practice Clinical guidelines and recommendations are not always followed and it is estimated that approximately 30-40 of patients receive treatment that is not based on scientific evidence and 20-25 receive treatments that are not needed or potentially harmful
Following the emergence of SARS-CoV-2 more than 660 million cases of COVID-19 have been reported worldwide with 183 million cases in the EU alone These numbers will continue to grow even after the disease becomes endemic In some 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 This is especially true for individuals aged 65 and older as the risk of NCDs increases with age
Diseases of the pulmonary cardiovascular and renal systems are the three major NCDs carrying the most significant burden for the individual as well as society Studies have documented compromised function of these 3 organ systems in the PAP of COVID-19 in 30-70 of patients regardless of the severity of the acute-phase As homeostasis of these three organs depends on interorgan communication with each other the impact of PAP of COVID-19 on one will impact the others The added stress of the PAP of COVID-19 increases the risk of a higher incidence andor the risk of an accelerated progression of disease
The prevalence and socioeconomic cost of the three NCDs is already extremely high Without a strong focus on minimmising the increased risk of incidence and accelerated progression of the NCDs as a result of the PAP of COVID-19 up to 9 million Europeans may be affected and result in an added direct attributable cost of between 19564 - 31064 per year for each person who develop an NCD
Beyond state of the art pulmonary cardiovascular and renal complications after the PAP of COVID-19
Post-acute COVID-19 and pulmonary complications - Respiratory conditions have been reported as occurring twice as often after severe COVID-19 as in the general population In a study of 135 individuals the incidence of impaired lung diffusing capacity DLCO and persistent lung damage was demonstrated in 30 of patients 12 months after acute COVID-19 In another study of 142 individuals pulmonary abnormalities were observed by CT scans in 54 of individuals a year after acute COVID-19
Post-acute COVID-19 and cardiovascular complications - The PAP of COVID-19 is associated with an increased risk of deep vein thrombosis up to three months after COVID-19 infection pulmonary embolism up to six months and a bleeding event up to two months In a registry study of 153760 individuals with COVID-19 the 12 month period following the acute phase was characterized by an increased risk and an excess disease burden of cardiovascular diseases including heart failure dysrhythmias and stroke The risks were evident regardless of age race sex and other cardiovascular risk factors MRI revealed cardiac impairment in 78 of 100 individuals in the PAP of COVID-19
Post-acute COVID-19 and renal complications - A study of 1733 individuals documented reduced renal function in 35 6 months after the acute phase of COVID-19 and 13 of patients who did not have acute kidney injury AKI during the acute phase showed a disproportionate reduction in renal function during follow-up A study including ampampgt89000 individuals revealed an increased risk of adverse renal outcomes in the PAP of COVID-19
The main unmet needs requiring action at the European level There is an urgent need to enable a better understanding of the causality between PAP of COVID-19 and the increased risk of pulmonary cardiovascular and renal complications and thereby an increased risk of onset of disease or aggravation of existing disease Even though recent studies suggest such a link there is a need for a more nuanced study of the correlation on much larger cohorts to determine the incidence and risk ratio more accurately Furthermore there is a need to compare the outcomes between the early present and potential future strains of SARS-CoV-2 variants responsible for the disease An increased cohort size will also allow a better understanding of the impact of socioeconomic status difference between sexes the compounding effects of genotype pre-existing comorbidities and use of prescription drugs and of differences between the PAP of early strains of SARS-CoV-2 in mostly unvaccinated individuals compared with current strains in mostly vaccinated people As this knowledge is currently incomplete there is an immediate risk that a large part of the European population will not receive optimal and timely care
Thus far investigators have concluded that the functional decline of organs caused by COVID-19 cannot be explained by known risk factors A review of the recent literature suggests that the PAP of COVID-19 is associated with immune dysregulation elevated levels of autoantibodies microbiota disruption and clotting and endothelial abnormalities However the same review also concludes that the current understanding is not sufficient to improve outcomes and calls for additional research This underscores the involvement of unidentified molecular mechanisms responsible for the aetiology A lack of understanding of these inhibits the development of effective biomarkers and drug candidates that allow optimal prediction of the prognosis and treatment of patients following resolution of the initial symptoms of COVID-19
There is an urgent need for updated clinical practice guidelines and new tools to diagnose and prevent the development and aggravation of NCDs caused by the PAP of COVID-19 Currently there are very few clinical guidelines and recommendations related to the PAP of COVID-19 and NCDs in general and there are even fewer clinical guidelines and recommendations that focus on the effects of the PAP of COVID-19 on pulmonary cardiovascular and renal health Modern clinical practice guidelines and recommendations that efficiently bridge the gap between research and current practice are invaluable for securing best quality of care patient outcomes and cost effectiveness Unfortunately the development of a guideline or a recommendation does not necessarily lead to changes in clinical practice Clinical guidelines and recommendations are not always followed and it is estimated that approximately 30-40 of patients receive treatment that is not based on scientific evidence and 20-25 receive treatments that are not needed or potentially harmful
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None