NCT04405544

Determination of Acute Encephalopathy Predictors in Patients With COVID-19

Completed NA Last updated 30 October 2020

What this trial tests

NA trial testing CT-scan in Encephalopathy in 51 participants. Completed in 29 October 2020.

Timeline

22 May 2020

Primary endpoint
22 July 2020

29 October 2020

Quick facts

Lead sponsor	State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	51
Start date	22 May 2020
Primary completion	22 July 2020
Estimated completion	29 October 2020
Sites	1 location across Russia

Drugs / interventions tested

• CT-scan
• EEG
• EP — full drug profile →
• Pulse oximetry
• Blood tests — full drug profile →

Conditions studied

• Encephalopathy — all drugs for Encephalopathy →
• COVID — all drugs for COVID →

Sponsor

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Who can join

Adults 18 to 60, any sex, with Encephalopathy or COVID. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. High sedation needs of critically ill COVID-19 ARDS patients-A monocentric observational study.
   Flinspach AN, Booke H, Zacharowski K, Balaban Ü, et al · · 2021 · cited 43× · PMID 34314422 · DOI 10.1371/journal.pone.0253778
2. Predictors of Acute Encephalopathy in Patients with COVID-19.
   Vinogradov OI, Ogarkova TK, Shamtieva KV, Alexandrov PV, et al · · 2021 · cited 3× · PMID 34768339 · DOI 10.3390/jcm10214821