Clinical Features of Severe Patients With COVID-19

NCT04450017 | Completed DMC

• 1 other identifier: COVID-ICU
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2

Keywords

SARS pneumonia; COVID-19; severe disease; risk factors

Outcome Measures

Primary Outcomes (3)

• Mechanical ventilation duration

  The amount of mechanical ventilation days

  30 days

• Non-invasive Mechanical ventilation duration

  The amount of Non-invasive mechanical ventilation days

  30 days

• Mortality

  The dead and survived patients ratio

  60 days

Secondary Outcomes (11)

• Сomplete blood count

  Change from baseline on day 5 during ICU treatment

• Biochemistry analysis

  Change from baseline on day 5 during ICU treatment

• Сomplete blood count dynamics

  Change from baseline on day 15 during ICU treatment

• Biochemistry analysis dynamics

  Change from baseline on day 15 during ICU treatment

• Computer tomography

  Change from baseline on day 5 during ICU treatment

Study Arms (1)

Clinical Features of Severe Patients With COVID-19

Critical ill patients with COVID-19 admitted to the ICU. The demographic, clinical data, laboratory data, and Instrumental data will be analysed.

Diagnostic Test: The demographic, clinical, laboratory, and instrumental data

Interventions

The demographic, clinical, laboratory, and instrumental data DIAGNOSTIC_TEST

Measurement of the demographic, clinical data, laboratory data, and instrumental data

Clinical Features of Severe Patients With COVID-19

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with COVID-19 requiring respiratory support

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal Research Clinical Center of Federal Medical & Biological Agency, Russia: lead

Study Sites (1)

Federal Research Clinical Center of Federal Medical & Biological Agency

Moscow, 115682, Russia

Location

Related Publications (4)

• 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.

  PMID: 32007143 BACKGROUND

• 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.

  PMID: 32441789 BACKGROUND

• 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.

  PMID: 32511655 BACKGROUND

• 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.

  PMID: 33982128 DERIVED

MeSH Terms

Conditions

COVID-19; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tatiana V Klypa, Dr.Med.Sc.

  Federal Research Clinical Center of Federal Medical & Biological Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 29, 2020
• Study Start: April 6, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 20, 2021

Record last verified: 2021-05

Locations

RU (1)