Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acquired Pneumonia (TARGET-VIP)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID 19

• Study Type: Observational
• Enrollment (Actual): 1130

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 101990
    • National Research Center for Preventive Medicine of the Ministry of Health
  • Moscow, Russian Federation, 105203
    • National Medical and Surgical Center named after N.I.Pirogov of the Ministry of Health of Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

From April 6, 2020 until the end of the work period of departments of NMSC, that are specialized for the treatment of patients with COVID-19 and community-acquired pneumonia all patients with inclusion criteria and who don't have exclusion criteria will be included in the study

Description

Inclusion Criteria:

1. 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.
2. Age 18 years and older.
3. Permanent residency in Russia.

Exclusion Criteria:

1. Permanent residency outside of Russia.
2. The patient's refusal to participate in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
COVID-19 with pneumonia; patients with positive COVID 19 by PCR and pneumonia by CT
COVID-19 without pneumonia; patients with positive COVID 19 by PCR and absent of pneumonia by CT
Patients with pneumonia and without COVID 19; patients with negative COVID 19 by PCR and with pneumonia by CT
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Proportion of patients with severe pneumonia	Damage area >50% according to the computer tomography data at any time point during hospitalization	from admission to discharge or death during reference hospitalization, assessed up to 90 days
Proportion of patients with low oxygen saturation value	SpO2 <90% - at any point during hospitalization	from admission to discharge or death during reference hospitalization, assessed up to 90 days
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	In patients with pneumonia during reference hospitalization time to recurrent pneumonia. In patients without pneumonia during reference hospitalization - time to first pneumonia	from discharge up to two years after reference hospitalization
Time to primary or recurrent coronavirus infection disease (COVID-19)	In patients without COVID-19 - time to primary diagnosis and in patients with COVID-19 - time to recurrent event	from discharge up to two years after reference hospitalization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	proportion of patients with thromboembolic events	from admission to discharge or death during reference hospitalization, assessed up to 90 days
Duration of Artificial Pulmonary Ventilation	the sum of the days when the patients required artificial pulmonary ventilation	from admission to discharge or death during reference hospitalization, assessed up to 90 days
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)	proportion of patients with rehospitalization due to pneumonia, COVID-19, flu and other acute respiratory infections (ARV)	from discharge up to two years after reference hospitalization
Hospitalization due to cardiovascular disease (CVD)	proportion of patients with hospitalization due to cardiovascular disease	from discharge up to two years after reference hospitalization
time to Flu and other ARV (except COVID-19)		from discharge up to two years after reference hospitalization

Collaborators and Investigators

• Sponsor: National Research Center for Preventive Medicine
• Collaborators: 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

Publications and helpful links

General Publications

• Drapkina O. M., Karpov O. E., Lukyanov M. M., Martsevich S. Yu., Pulin A. A., Kutishenko N. P., Akimkin V. G., Andreenko E. Yu., Voronina V. P., Dindikova V. A., Dmitrieva N. A., Zagrebelnyi A. V., Ler- man O. V., Makoveeva A. N., Okshina E. Yu., Kudryashov E. V., Klyashtorny V. G., Smirnov A. A., Fomina V. S. Prospective in-hospital registry of patients with suspected or documented COVID-19 infection and community acquired pneumonia (TARGET-VIP): characteristics of patients and assessment of in-hospital outcomes. Cardiovascular Therapy and Prevention. 2020;19(6):2727. (In Russ.) doi:10.15829/1728-8800-2020-2727
• Drapkina OM, Karpov OE, Loukyanov MM, Martsevich SYu, Pulin AA, Kutishenko NP, Akimkin VG, Andreenko EYu, Voronina VP, Dindikova VA, Dmitrieva NA, Zagrebelnyy AV, Lerman OV, Makoveeva AN, Okshina EYu, Kudryashov EV, Klyashtorniy VG, Smirnov AA, Fomina VS. Experience of creating and the first results of the prospective hospital registry of patients with suspected or confirmed coronavivirus infection (COVID-19) and community-acquired pneumonia (TARGET-VIP). The Russian Journal of Preventive Medicine. 2020;23(8):6- 13. (In Russ.). https://doi.org/10.17116/profmed2020230816
• Lukyanov M.M., Martsevich S.Yu., Pulin A.A., Kutishenko N.P., Andreenko E.Yu., Voronina V.P., Dindikova V.A., Dmitrieva N.A., Zagrebelny A.V., Makoveeva A.N., Lerman O.V., Okshina E.Yu., Sgibneva A. S., Smirnov A. A., Belova E. N., Klyashtorny V. G., Kudryashov E.V., Karpov O.E., Drapkina O.M. Dynamics of age characteristics and prevalence of concomitant cardiovascular and non-сardiovascular diseases in patients hospitalized with COVID-19 during epidemic wave: data from TARGET-VIP registry. Cardiovascular Therapy and Prevention. 2021;20(8):3106. (In Russ.) doi:10.15829/1728-8800-20213106
• : Martsevich S.Yu., Lukyanov M.M., Pulin A.A., Kutishenko N.P., Andreenko E.Yu., Voronina V.P., Dindikova V.A., Dmitrieva N.A., Zagrebelnyy A.V., Lerman O.V., Makoveeva A.N., Okshina E.Yu., Smirnov A.A., Kudryashov E.V., Budaeva I.V., Nikoshnova E.S., Karpov O.E., Drapkina O.M. Prehospital Period in Patients with COVID-19: Cardiovascular Comorbidity and Pharmacotherapy During the First Epidemic Wave (Hospital Registry Data). Rational Pharmacotherapy in Cardiology 2021;17(6):873-879. DOI:10.20996/1819-6446-2021-12-13
• Lukyanov M.M., Kutishenko N.P., Martsevich S.Yu., Pulin A.A., And - reenko E. Yu., Voronina V.P., Dindikova V.A., Dmitrieva N.A., Lerman O.V., Makove - eva A.N., Okshina E.Yu., Sgibneva A.S., Smirnov A.A., Belova E.N., Klyashtorny V.G.,Kudryashov E.V., Karpov O.E., Drapkina O.M. Long-term outcomes in patients after COVID-19: data from the TARGET-VIP registry. Russian Journal of Cardiology. 2022;27(3):4912. doi:10.15829/1560-4071-2022-4912
• Smirnov A.A., Loukianov M.M., Martsevich S.Yu., Pulin A.A., Kutishenko N.P., Andreenko E.Yu., Voronina V.P., Dindikova V.A., Dmitrieva N.A., Kudryavtseva M.M., Lerman O.V., Makoveeva A.N., Okshina E.Yu., Maltseva A.A., Belova E.N., Klyashtorniy V.G., Kudryashov E.V., Karpov O.E., Drapkina O.M. Clinical and Anamnestic Characteristics, Cardiovascular Pharmacotherapy and Long-term Outcomes in Multimorbid Patients after COVID-19. Rational Pharmacotherapy in Cardiology 2022;18(5):502-509. DOI:10.20996/1819-6446-2022-09-06
• Loukyanov MM, Andreenko EYu, Martsevich SYu, Kutishenko NP, Voronina VP, Dindikova VA, Dmitrieva NA, Kudryavtseva MM, Lerman OV, Makoveeva AN, Okshina EYu, Smirnov AA, Belova EN, Kudryashov EV, Litinskaya OA, Dzodzuashvili LR, Karpov OE, Pulin AA, Drapkina OM. Long-term follow-up of patients after COVID-19: adherence to SARS-CoV-2 vaccination and immune status. Profilakticheskaya Meditsina. 2022;25(12):88-95. (In Russ.). https://doi.org/10.17116/profmed20222512188
• Kutishenko N.P., Lukyanov M.M., Martsevich S.Yu., Pulin A.A., Andreenko E.Yu., Voronina V.P., Dindikova V.A., Dmitrieva N.A., Kudryavtseva M.M., Lerman O.V., Makoveeva A.N., Okshina E.Yu., Smirnov А.А., Belova E.N., Klyashtorny V.G., Kudryashov E.V., Karpov O.E., Drapkina O.M. Medical treatment of patients with cardiovascular diseases during the first year after hospitalization for COVID-19. Cardiovascular Therapy and Prevention. 2022;21(12):3467. (In Russ.) https://doi.org/10.15829/1728-8800-2022-3467
• Mareev Yu.V., Lukyanov M.M., Martsevich S.Yu., Pulin A.A., Kutishenko N.P., Andreenko E.Yu., Voronina V.P., Dindikova V.A., Dmitrieva N.A., Makoveeva A.N., Lerman O.V., Okshina E.Yu., Smirnov A.A., Kudryavtseva M.M., Belova E.N., Klyashtorny V.G., Kudryashov E.V., Karpov O.E., Drapkina O.M. Detection rate and characteristics of heart failure, depending on the diagnostic criteria in COVID-19 survivors one year after hospitalization. Cardiovascular Therapy and Prevention. 2022;21(12):3437. (In Russ.) https://doi.org/10.15829/1728-8800-2022-3437
• Lukyanov M.M., Andreenko E. Yu., Martsevich S. Yu., Kutishenko N.P., Voronina V.P., Dindikova V.A., Dmitrieva N.A., Kudryavtseva M.M., Lerman O.V., Makoveeva A.N., Okshina E. Yu., Pulin A.A., Smirnov A.A., Klyashtorny V.G., Karpov O.E., Drapkina O.M. Two-year outcomes in patients after hospitalization for COVID-19: data from the TARGET-VIP registry. Cardiovascular Therapy and Prevention. 2023;22(10):3757. doi:10.15829/1728-8800-2023-3757
• Smirnov AA, Loukianov MM, Martsevich SYu, Kutishenko NP, Andreenko EYu, Voronina VP, Dindikova VA, Dmitrieva NA, Kudryavtseva MM, Lerman OV, Makoveeva AN, Okshina EYu, Smirnova MI, Pulin AA, Karpov OE, Drapkina OM. Long-term outcomes in patients with cardiovascular multimorbidity suffered from COVID-19: two-year observation. The Russian Journal of Preventive Medicine. 2023;26(12):58-64. (In Russ.). https://doi.org/10.17116/profmed20232612158

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Coronaviridae Infections; Nidovirales Infections; COVID-19; Pneumonia; Coronavirus Infections
• Other Study ID Numbers: 02-07/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No