French Single Centre Experience of Critically Ill Patients With Covid 19
NCT04354558
COVID 19, COVID-19
Amiens, France
View Trial DetailsNCT Number: NCT04522076
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
National Medical and Surgical Center named after N.I.Pirogov of the Ministry of Health of Russian Federation, Moscow, Russia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Time frame: from discharge up to two years after reference hospitalization
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Damage area >50% according to the computer tomography data at any time point during hospitalization
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
SpO2 <90% - at any point during hospitalization
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Time frame: from discharge up to two years after reference hospitalization
Time frame: from discharge up to two years after reference hospitalization
Time frame: from discharge up to two years after reference hospitalization
In patients with pneumonia during reference hospitalization time to recurrent pneumonia. In patients without pneumonia during reference hospitalization - time to first pneumonia
Time frame: from discharge up to two years after reference hospitalization
In patients without COVID-19 - time to primary diagnosis and in patients with COVID-19 - time to recurrent event
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
proportion of patients with thromboembolic events
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
the sum of the days when the patients required artificial pulmonary ventilation
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Time frame: from discharge up to two years after reference hospitalization
proportion of patients with rehospitalization due to pneumonia, COVID-19, flu and other acute respiratory infections (ARV)
Time frame: from discharge up to two years after reference hospitalization
proportion of patients with hospitalization due to cardiovascular disease
Time frame: from discharge up to two years after reference hospitalization
National Research Center for Preventive Medicine
Other Gov
Acronym: TARGET-VIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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