Clinical Features of Severe Patients With COVID-19

SARS-CoV2 Clinical Trial

Official title:

Clinical Features of Severe Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450017
• Other study ID #: COVID-ICU
• Status: Completed
• Start date: April 6, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2021
• Source: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

As coronavirus disease 2019 (COVID-19) spreads across the world, the intensive care unit (ICU) community must prepare for the challenges associated with this pandemic. Providing an efficient care to the patients of the most severely affected category - intensive care unit (ICU) patients - has become one of the serious problems appearing in the COVID-19 pandemics. A typical patient's clinical portrait in ICU of COVID centers is very similar in different countries, however, the key to improve the treatment results for critically ill patients has not yet been found. Data on predictors of severe course in COVID-19 is limited. Knowledge of predictors of severe course of disease can lead to different selection of therapeutic strategy, determine the group of risk of patients for severe course of disease, and improve outcomes.

Description:

The clinical disease (COVID-19) results in critical illness in about 5% of patients. The aim of the study is to identify predictors of the severe pneumonia caused by the SARS-CoV-2 virus, and to describe the clinical features of patients admitted to an ICU of the COVID-center of the Federal Research Clinical Center of Federal Medical & Biological Agency on the first day and in dynamics till discharge from the ICU or death.

The demographic and clinical data will be collected. Laboratory data (hemoglobin, lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, IL-6, procalcitonin, glucose level, high-sensitive troponin Т, vitamin D level, signs of the presence of a secondary bacterial infection, immunogram and Instrumental data (CT-scan, Electrocardiography, echocardiography, arterial and venous ultrasound investigation) will be analysed.

This study is singlecentral observational trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• all patients with COVID-19 admitted to the ICU with invasive and noninvasive ventilation

Exclusion Criteria:

• less than 24 hours in ICU by any reason,

• chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure),

• atonic coma.

Related Conditions & MeSH terms

• SARS-CoV2

Intervention

Diagnostic Test:
• The demographic, clinical, laboratory, and instrumental data
Measurement of the demographic, clinical data, laboratory data, and instrumental data

Locations

Country	Name	City	State
Russian Federation	Federal Research Clinical Center of Federal Medical & Biological Agency	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30. — View Citation

Paranjpe I, Russak A, De Freitas JK, Lala A, Miotto R, Vaid A, Johnson KW, Danieletto M, Golden E, Meyer D, Singh M, Somani S, Manna S, Nangia U, Kapoor A, O'Hagan R, O'Reilly PF, Huckins LM, Glowe P, Kia A, Timsina P, Freeman RM, Levin MA, Jhang J, Firpo A, Kovatch P, Finkelstein J, Aberg JA, Bagiella E, Horowitz CR, Murphy B, Fayad ZA, Narula J, Nestler EJ, Fuster V, Cordon-Cardo C, Charney DS, Reich DL, Just AC, Bottinger EP, Charney AW, Glicksberg BS, Nadkarni G. Clinical Characteristics of Hospitalized Covid-19 Patients in New York City. medRxiv. 2020 Apr 23. pii: 2020.04.19.20062117. doi: 10.1101/2020.04.19.20062117. — View Citation

Tian W, Jiang W, Yao J, Nicholson CJ, Li RH, Sigurslid HH, Wooster L, Rotter JI, Guo X, Malhotra R. Predictors of mortality in hospitalized COVID-19 patients: A systematic review and meta-analysis. J Med Virol. 2020 Oct;92(10):1875-1883. doi: 10.1002/jmv.26050. Epub 2020 Jul 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical ventilation duration	The amount of mechanical ventilation days	30 days
Primary	Non-invasive Mechanical ventilation duration	The amount of Non-invasive mechanical ventilation days	30 days
Primary	Mortality	The dead and survived patients ratio	60 days
Secondary	?omplete blood count	?omplete blood count	Change from baseline on day 5 during ICU treatment
Secondary	Biochemistry analysis	Biochemistry analysis	Change from baseline on day 5 during ICU treatment
Secondary	?omplete blood count dynamics	?omplete blood count	Change from baseline on day 15 during ICU treatment
Secondary	Biochemistry analysis dynamics	Biochemistry analysis	Change from baseline on day 15 during ICU treatment
Secondary	Computer tomography	Computer tomography of lungs	Change from baseline on day 5 during ICU treatment
Secondary	High-sensitive troponin ?	High-sensitive troponin ?	Change from baseline on day 5 during ICU treatment
Secondary	High-sensitive troponin ? dynamics	High-sensitive troponin ?	Change from baseline on day 15 during ICU treatment
Secondary	Vitamin D level	Vitamin D level	Change from baseline on day 5 during ICU treatment
Secondary	Vitamin D level dynamics	Vitamin D level	Change from baseline on day 15 during ICU treatment
Secondary	Immunogram	Immunogram	Change from baseline on day 5 during ICU treatment
Secondary	Immunogram dynamics	Immunogram	Change from baseline on day 15 during ICU treatment