Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04522076
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-19
First Post:
2020-08-18
Brief Title:
Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection COVID-19 and Community-acquired Pneumonia
Sponsor:
National Research Center for Preventive Medicine
Organization:
National Medical Research Center for Therapy and Preventive Medicine
Study Overview
Official Title:
Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection COVID-19 and Community-acquired Pneumonia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TARGET-VIP
Brief Summary:
Coronavirus-2019 disease COVID-19 and community-acquired pneumonia are significant problems of modern medicine Pneumonia is the most common severe complication of COVID-19 But at the same time COVID-19 is not the only cause of community-acquired pneumonia Moreover pneumonia is only one of the numerous possible severe complications of COVID-19 Medical centers specialized for the hospital treatment of patients with severe COVID-19 and community-acquired pneumonia were organized in different regions of Russia during coronavirus pandemic-2020 The indications for hospitalization to one of these centers based in the National Medical and Surgical Center NMSC are confirmed or suspected severe COVID-19 or community-acquired pneumonia
A prospective medical registry of such patients hospitalized to NMSC is intended to analyze and compare their clinical and instrumental data co-morbidity treatment short-term and long-term outcomes in real clinical practice
Stage 1 Hospital treatment in NMSC
Duration of this stage from the date of admission to the hospital up to the date of discharge from the hospital or up to the date of death during the reference hospitalization The date of admission to the hospital will be the date of enrollment to the study
Evaluation of electronic health record data using the Medical Information System MIS Assessment of the outcomes of the hospital phase discharge from the hospital death and significant events acute respiratory and pulmonary failure requiring mechanical ventilation cardiovascular events - myocardial infarction cerebral stroke acute heart failure paroxysmal heart rhythm disturbances bleedings thrombosis of large vessels and thromboembolic complications A survey of patients to clarify data on risk factors somatic diseases and drug therapy before hospitalization
COVID-19 was diagnosed when severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 infection was confirmed by Polymerase chain reaction PCR Pneumonia was confirmed according to computerized tomography CT data
Stage 2 Prospective outpatient follow-up for 24 months
Duration of this stage 24 months after discharge from the hospital This work will be delivered by investigators from the National Medical Research Center for Therapy and Preventive Medicine
Evaluation of long-term outcomes and events among residents of Moscow and the Moscow Region according to a patient survey contact by phone for 30-60 days 6 months 12 and 24 months after discharge from the hospital and medical records
A prospective medical registry of such patients hospitalized to NMSC is intended to analyze and compare their clinical and instrumental data co-morbidity treatment short-term and long-term outcomes in real clinical practice
Stage 1 Hospital treatment in NMSC
Duration of this stage from the date of admission to the hospital up to the date of discharge from the hospital or up to the date of death during the reference hospitalization The date of admission to the hospital will be the date of enrollment to the study
Evaluation of electronic health record data using the Medical Information System MIS Assessment of the outcomes of the hospital phase discharge from the hospital death and significant events acute respiratory and pulmonary failure requiring mechanical ventilation cardiovascular events - myocardial infarction cerebral stroke acute heart failure paroxysmal heart rhythm disturbances bleedings thrombosis of large vessels and thromboembolic complications A survey of patients to clarify data on risk factors somatic diseases and drug therapy before hospitalization
COVID-19 was diagnosed when severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 infection was confirmed by Polymerase chain reaction PCR Pneumonia was confirmed according to computerized tomography CT data
Stage 2 Prospective outpatient follow-up for 24 months
Duration of this stage 24 months after discharge from the hospital This work will be delivered by investigators from the National Medical Research Center for Therapy and Preventive Medicine
Evaluation of long-term outcomes and events among residents of Moscow and the Moscow Region according to a patient survey contact by phone for 30-60 days 6 months 12 and 24 months after discharge from the hospital and medical records
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None