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

COVID 19 Clinical Trial

— TARGET-VIP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04522076
• Other study ID #: 02-07/20
• Status: Active, not recruiting
• Start date: April 6, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1130
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID 19
• COVID-19
• Pneumonia

Locations

Country	Name	City	State
Russian Federation	National Medical and Surgical Center named after N.I.Pirogov of the Ministry of Health of Russian Federation	Moscow
Russian Federation	National Research Center for Preventive Medicine of the Ministry of Health	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Russian Federation, 

References & Publications (11)

: 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., Kar

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., Kudryash

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.

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 ?.?., Belova E.N., Klyashtorny V.G., Kudryashov E.V., Karp

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, Drapkin

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-

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., Ka

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., Kudr

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., Kudryas

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., Kudr

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 card

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	proportion of patients with nonfatal myocardial infarction		from admission to discharge or death during reference hospitalization, assessed up to 90 days
Other	proportion of patients with nonfatal cerebral stroke		from admission to discharge or death during reference hospitalization, assessed up to 90 days
Other	proportion of patients with bleedings		from admission to discharge or death during reference hospitalization, assessed up to 90 days
Other	thromboembolic events	proportion of patients with thromboembolic events	from admission to discharge or death during reference hospitalization, assessed up to 90 days
Other	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
Other	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
Other	Minimal value of hemoglobin (Hb) during the hospital stage		from admission to discharge or death during reference hospitalization, assessed up to 90 days
Other	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
Other	Hospitalization due to cardiovascular disease (CVD)	proportion of patients with hospitalization due to cardiovascular disease	from discharge up to two years after reference hospitalization
Other	time to Flu and other ARV (except COVID-19)		from discharge up to two years after reference hospitalization
Primary	Overall survival		from admission to discharge or death during reference hospitalization, assessed up to 90 days
Primary	Time to all-cause mortality or Artificial Pulmonary Ventilation (APV)		from admission to discharge or death during reference hospitalization, assessed up to 90 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall survival		from discharge up to two years after reference hospitalization
Secondary	Time to nonfatal myocardial infarction, nonfatal cerebral stroke, and coronary or carotid revascularization		from discharge up to two years after reference hospitalization
Secondary	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
Secondary	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