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Determination of Acute Encephalopathy Predictors in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405544
Recruitment Status : Completed
First Posted : May 28, 2020
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Oleg Vinogradov, State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Encephalopathy COVID Diagnostic Test: CT-scan Diagnostic Test: EEG Diagnostic Test: EP Diagnostic Test: Pulse oximetry Diagnostic Test: Blood tests Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of Acute Encephalopathy Predictors in Patients With COVID-19
Actual Study Start Date : May 22, 2020
Actual Primary Completion Date : July 22, 2020
Actual Study Completion Date : October 29, 2020

Arm Intervention/treatment
Main
patients with COVID-19 and Acute Encephalopathy
Diagnostic Test: CT-scan
chest CT-scan

Diagnostic Test: EEG
Electroencephalography

Diagnostic Test: EP
Evoked potential

Diagnostic Test: Pulse oximetry
Pulse oximetry

Diagnostic Test: Blood tests
Blood tests

Control
patients with COVID-19 without Acute Encephalopathy
Diagnostic Test: CT-scan
chest CT-scan

Diagnostic Test: EEG
Electroencephalography

Diagnostic Test: EP
Evoked potential

Diagnostic Test: Pulse oximetry
Pulse oximetry

Diagnostic Test: Blood tests
Blood tests




Primary Outcome Measures :
  1. The percentage of patients who have developed encephalopathy [ Time Frame: 10 days ]
    The percentage of patients who have developed encephalopathy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405544


Locations
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Russian Federation
N.I. Pirogov National Medical and Surgical Center
Moscow, Russian Federation, 105203
Sponsors and Collaborators
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Investigators
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Principal Investigator: Oleg I Vinogradov, MD, PhD N.I. Pirogov National Medical and Surgical Center
Publications:
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Responsible Party: Oleg Vinogradov, MD, PhD, State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
ClinicalTrials.gov Identifier: NCT04405544    
Other Study ID Numbers: NMSC-01-20
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases