SARS-CoV2 Clinical Trial
Official title:
Clinical Features of Severe Patients With COVID-19
NCT number | NCT04450017 |
Other study ID # | COVID-ICU |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 6, 2020 |
Est. completion date | June 30, 2020 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Federal Research Clinical Center of Federal Medical & Biological Agency | Moscow |
Lead Sponsor | Collaborator |
---|---|
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia |
Russian Federation,
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
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 |
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