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NCT Number: NCT04522076

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Medical and Surgical Center named after N.I.Pirogov of the Ministry of Health of Russian Federation, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Age 18 years and older.
  • Permanent residency in Russia.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Research Center for Preventive Medicine

Other Gov

Collaborators

  • National Medical and Surgical Center named after N.I. Pirogov of the Ministry of Healthcare of the Russian Federation

Registry information

Acronym: TARGET-VIP

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2020
Registry last updated
May 30, 2025

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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