TARGET-VIP: Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acquired Pneumonia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID-19 with pneumonia patients with positive COVID 19 by PCR and pneumonia by CT |
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| COVID-19 without pneumonia patients with positive COVID 19 by PCR and absent of pneumonia by CT |
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| Patients with pneumonia and without COVID 19 patients with negative COVID 19 by PCR and with pneumonia by CT |
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| Patients without pneumonia and COVID 19 Patients with suspected COVID-19 and/or pneumonia at the pre-hospital stage that were not confirmed in hospital |
Outcome Measures
Primary Outcome Measures
- Overall survival [from admission to discharge or death during reference hospitalization, assessed up to 90 days]
- Time to all-cause mortality or Artificial Pulmonary Ventilation (APV) [from admission to discharge or death during reference hospitalization, assessed up to 90 days]
- Time to all-cause mortality, nonfatal myocardial infarction, nonfatal cerebral stroke, and coronary or carotid revascularization [from discharge up to two years after reference hospitalization]
Secondary Outcome Measures
- Proportion of patients with severe pneumonia [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
- Proportion of patients with low oxygen saturation value [from admission to discharge or death during reference hospitalization, assessed up to 90 days]
SpO2 <90% - at any point during hospitalization
- Proportion of patients with Hb <90 g/l (9.0 g/dl) at any point during hospitalization [from admission to discharge or death during reference hospitalization, assessed up to 90 days]
- Proportion of patients hospitalized or transferred to Intensive Care Unit (ICU) [from admission to discharge or death during reference hospitalization, assessed up to 90 days]
- Overall survival [from discharge up to two years after reference hospitalization]
- Time to nonfatal myocardial infarction, nonfatal cerebral stroke, and coronary or carotid revascularization [from discharge up to two years after reference hospitalization]
- Time to pneumonia/recurrent pneumonia [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 to primary or recurrent coronavirus infection disease (COVID-19) [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
Other Outcome Measures
- proportion of patients with nonfatal myocardial infarction [from admission to discharge or death during reference hospitalization, assessed up to 90 days]
- proportion of patients with nonfatal cerebral stroke [from admission to discharge or death during reference hospitalization, assessed up to 90 days]
- proportion of patients with bleedings [from admission to discharge or death during reference hospitalization, assessed up to 90 days]
- thromboembolic events [from admission to discharge or death during reference hospitalization, assessed up to 90 days]
proportion of patients with thromboembolic events
- Duration of Artificial Pulmonary Ventilation [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
- Minimal value of oxygen blood saturation (SpO2) during the hospital stage. [from admission to discharge or death during reference hospitalization, assessed up to 90 days]
- Minimal value of hemoglobin (Hb) during the hospital stage [from admission to discharge or death during reference hospitalization, assessed up to 90 days]
- Rehospitalization due to pneumonia, COVID-19, flu and other acute respiratory infections (ARV) [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)
- Hospitalization due to cardiovascular disease (CVD) [from discharge up to two years after reference hospitalization]
proportion of patients with hospitalization due to cardiovascular disease
- time to Flu and other ARV (except COVID-19) [from discharge up to two years after reference hospitalization]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients hospitalized to the National Medical and Surgical Center named after N.I.Pirogov of the Ministry of Health of Russia (NMSC) with suspected or confirmed COVID-19 or community-acquired pneumonia.
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Age 18 years and older.
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Permanent residency in Russia.
Exclusion Criteria:
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Permanent residency outside of Russia.
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The patient's refusal to participate in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Research Center for Preventive Medicine of the Ministry of Health | Moscow | Russian Federation | 101990 | |
| 2 | National Medical and Surgical Center named after N.I.Pirogov of the Ministry of Health of Russian Federation | Moscow | Russian Federation | 105203 |
Sponsors and Collaborators
- National Research Center for Preventive Medicine
- National Medical and Surgical Center named after N.I. Pirogov of the Ministry of Healthcare of the Russian Federation
Investigators
- Study Chair: Sergey Martsevich, MD, PhD, National Medical Research Center for Therapy and Preventive Medicine
- Study Chair: Mikhail Loukianov, MD, PhD, National Medical Research Center for Therapy and Preventive Medicine
- Study Chair: Andrey Pulin, MD, PhD, National Medical and Surgical Center named after N.I.Pirogov
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 02-07/20