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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04522076
Recruitment Status : Active, not recruiting
First Posted : August 21, 2020
Last Update Posted : February 10, 2022
Sponsor:
Collaborator:
National Medical and Surgical Center named after N.I. Pirogov of the Ministry of Healthcare of the Russian Federation
Information provided by (Responsible Party):
National Medical Research Center for Therapy and Preventive Medicine ( National Research Center for Preventive Medicine )

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
COVID 19

Study Design
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Study Type : Observational
Actual Enrollment : 1124 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acquired Pneumonia
Actual Study Start Date : April 6, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days ]
  2. Time to all-cause mortality or Artificial Pulmonary Ventilation (APV) [ Time Frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days ]
  3. Time to all-cause mortality, nonfatal myocardial infarction, nonfatal cerebral stroke, and coronary or carotid revascularization [ Time Frame: from discharge up to two years after reference hospitalization ]

Secondary Outcome Measures :
  1. Proportion of patients with severe pneumonia [ 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

  2. Proportion of patients with low oxygen saturation value [ Time Frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days ]
    SpO2 <90% - at any point during hospitalization

  3. Proportion of patients with Hb <90 g/l (9.0 g/dl) at any point during hospitalization [ Time Frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days ]
  4. Proportion of patients hospitalized or transferred to Intensive Care Unit (ICU) [ Time Frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days ]
  5. Overall survival [ Time Frame: from discharge up to two years after reference hospitalization ]
  6. Time to nonfatal myocardial infarction, nonfatal cerebral stroke, and coronary or carotid revascularization [ Time Frame: from discharge up to two years after reference hospitalization ]
  7. Time to pneumonia/recurrent pneumonia [ 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

  8. Time to primary or recurrent coronavirus infection disease (COVID-19) [ 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


Other Outcome Measures:
  1. proportion of patients with nonfatal myocardial infarction [ Time Frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days ]
  2. proportion of patients with nonfatal cerebral stroke [ Time Frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days ]
  3. proportion of patients with bleedings [ Time Frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days ]
  4. thromboembolic events [ Time Frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days ]
    proportion of patients with thromboembolic events

  5. Duration of Artificial Pulmonary Ventilation [ 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

  6. Minimal value of oxygen blood saturation (SpO2) during the hospital stage. [ Time Frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days ]
  7. Minimal value of hemoglobin (Hb) during the hospital stage [ Time Frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days ]
  8. 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 rehospitalization due to pneumonia, COVID-19, flu and other acute respiratory infections (ARV)

  9. Hospitalization due to cardiovascular disease (CVD) [ Time Frame: from discharge up to two years after reference hospitalization ]
    proportion of patients with hospitalization due to cardiovascular disease

  10. time to Flu and other ARV (except COVID-19) [ Time Frame: from discharge up to two years after reference hospitalization ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522076


Locations
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Russian Federation
National Research Center for Preventive Medicine of the Ministry of Health
Moscow, Russian Federation, 101990
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
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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
More Information
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Publications of Results:
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

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Responsible Party: National Research Center for Preventive Medicine
ClinicalTrials.gov Identifier: NCT04522076    
Other Study ID Numbers: 02-07/20
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Coronavirus Infections
Infections
Respiratory Tract Infections
Pneumonia, Viral
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases