Clinical trial NCT04450017: Clinical Features of Severe Patients With COVID-19
Official title: Clinical Features of Severe Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2
Keywords: SARS pneumonia
COVID-19
severe disease
risk factors
Lead sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Sponsor class: OTHER_GOV
First posted: 2020-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with COVID-19 requiring respiratory support

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mechanical ventilation duration
timeFrame: 30 days
measure: Non-invasive Mechanical ventilation duration
timeFrame: 30 days
measure: Mortality
timeFrame: 60 days
Secondary outcomes:
measure: Сomplete blood count
timeFrame: Change from baseline on day 5 during ICU treatment
measure: Biochemistry analysis
timeFrame: Change from baseline on day 5 during ICU treatment
measure: Сomplete blood count dynamics
timeFrame: Change from baseline on day 15 during ICU treatment
measure: Biochemistry analysis dynamics
timeFrame: Change from baseline on day 15 during ICU treatment
measure: Computer tomography
timeFrame: Change from baseline on day 5 during ICU treatment
measure: High-sensitive troponin Т
timeFrame: Change from baseline on day 5 during ICU treatment
measure: High-sensitive troponin Т dynamics
timeFrame: Change from baseline on day 15 during ICU treatment
measure: Vitamin D level
timeFrame: Change from baseline on day 5 during ICU treatment
measure: Vitamin D level dynamics
timeFrame: Change from baseline on day 15 during ICU treatment
measure: Immunogram
timeFrame: Change from baseline on day 5 during ICU treatment
measure: Immunogram dynamics
timeFrame: Change from baseline on day 15 during ICU treatment
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Research Clinical Center of Federal Medical & Biological Agency
Study officials:
affiliation: Federal Research Clinical Center of Federal Medical & Biological Agency
name: Tatiana V Klypa, Dr.Med.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Paranjpe I, Russak AJ, 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 GN. Clinical Characteristics of Hospitalized Covid-19 Patients in New York City. medRxiv [Preprint]. 2020 Apr 26:2020.04.19.20062117. doi: 10.1101/2020.04.19.20062117.
citation: Bychinin MV, Klypa TV, Mandel IA, Andreichenko SA, Baklaushev VP, Yusubalieva GM, Kolyshkina NA, Troitsky AV. Low Circulating Vitamin D in Intensive Care Unit-Admitted COVID-19 Patients as a Predictor of Negative Outcomes. J Nutr. 2021 Aug 7;151(8):2199-2205. doi: 10.1093/jn/nxab107.