COVID Clinical Trial
Official title:
Determination of Acute Encephalopathy Predictors in Patients With COVID-19
The SARS-CoV-2 infection was detected in December 2019 in Wuhan City, China. The infection affects all age groups, although childhood is the lowest proportion of those affected. The main clinical manifestations that require hospitalization of infected patients are SARS pneumonia, which may require treatment in the intensive care unit (27%) and its progression into acute respiratory distress syndrome (67%) with life-threatening conditions in almost 25% of patients diagnosed with "SARS-CoV-2 infection". Nervous system damage with SARS-CoV-2 infection has been practically not investigated, but neurological disorders have been reported in 36% of these patients. Finally, the mortality rate associated with the new virus is high in patients who require treatment in intensive care units (62% of cases). Therefore, we are conducting a prospective study to identify acute encephalopathy predictors in patients with COVID-19.
Status | Completed |
Enrollment | 51 |
Est. completion date | October 29, 2020 |
Est. primary completion date | July 22, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Men and women aged 18 to 60 years - Out-of-hospital pneumonia with confirmed pulmonary tissue infiltration according to CT with changes corresponding to the average and high probability of coronavirus pneumonia (4-5 levels by CO-RADS classification) and the loss of more than 25% of one of the lungs. - The patient has read the information sheet and signed the informed consent form. Exclusion Criteria: - Negative PCR test for coronavirus infection. - The presence in the anamnesis of data for myocardial infarction or stroke. - Verified thrombophilia. - Pregnancy. - Patients with malignant tumors (including anamnesis), including postoperative period in the background of chemo and/or radiation therapy. - Acute stroke. Dropout Criteria: - Patient's refusal to participate further in the study. - Negative PCR result for coronavirus infection. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | N.I. Pirogov National Medical and Surgical Center | Moscow |
Lead Sponsor | Collaborator |
---|---|
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia |
Russian Federation,
Slooter AJC, Otte WM, Devlin JW, Arora RC, Bleck TP, Claassen J, Duprey MS, Ely EW, Kaplan PW, Latronico N, Morandi A, Neufeld KJ, Sharshar T, MacLullich AMJ, Stevens RD. Updated nomenclature of delirium and acute encephalopathy: statement of ten Societies. Intensive Care Med. 2020 May;46(5):1020-1022. doi: 10.1007/s00134-019-05907-4. Epub 2020 Feb 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The percentage of patients who have developed encephalopathy | The percentage of patients who have developed encephalopathy | 10 days |
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