Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04359914
Other study ID # COVID-BRAIN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date December 31, 2023

Study information

Verified date January 2024
Source University of Rostock
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Delirium and acute neurocognitive impairment are increasingly observed in adult and pediatric patients with COVID-19. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed for COVID-19. The value of biomarkers of neuroaxonal injury was proven in preliminary studies. These biomarkers could thus contribute to the systematic detection of neurocognitive impairment in patients with COVID-19. Due to worldwide increasing numbers of hospitalized patients with COVID-19, biomarkers of neuroaxonal injury are highly valuable to detect and monitor cognitive impairment, especially with regard to limited resources available to perform time-consuming brain imaging. Biomarkers of neuroaxonal injury are therefore not only of great interest to detect neurocognitive impairment but also to quantify the severity of brain injury in patients with COVID-19.


Description:

This is a multicenter observational study evaluating the incidence and severity of neurocognitive impairment in adult and pediatric patients with COVID-19. All study participants will be assessed by clinical and neurological examination as well as comprehensive laboratory tests using biomarkers of neuroaxonal injury at study day 1 (day of study inclusion), day 3, day 7 and day of hospital discharge. A panel of biomarkers (among others NSE, S100B and neurofilament proteins) will be measured. Clinical assessment will be performed using validated delirium tests (among others CAM-ICU, ICDSC) and scales to assess the neurocognitive performance of study participants before and three months after study inclusion (among others Short Blessed Test). A group of patients with a comparable severity of disease but without the detection of SARS-Cov-2 will serve as control group and will undergo the same clinical and laboratory examinations. We hypothesize, that: - patients with COVID-19 are more likely to develop delirium and neurocognitive impairment than patients without COVID-19 - patients with a preexisting neurocognitive deficit are more vulnerable to neurocognitive impairment in the course of COVID-19 than patients without a preexisting neurocognitive deficit - Specific biomarkers of neuroaxonal injury correlate with the clinical severity of acute neurocognitive impairment and can predict the 3-month neurocognitive outcome of patients with COVID-19


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date December 31, 2023
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - adult patients of every age - admission to hospital with suspected COVID-19 disease - confirmed SARS-CoV-2 infection within 48 hours after admission Exclusion Criteria: - transferral from another hospital - other acute central nervous system diseases (e.g. meningoencephalitis, intracerebral ischemia or hemorrhage) - confirmed SARS-CoV-2 infection later than 48 hours after hospital admission - participation in another interventional study - no written informed consent from patient or legal representative

Study Design


Locations

Country Name City State
Germany Department of Anesthesiology and Intensive Care Medicine, University Medical Center Rostock Rostock Mecklenburg-Vorpommern

Sponsors (3)

Lead Sponsor Collaborator
University of Rostock Ludwig-Maximilians - University of Munich, University College, London

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19 Assessment of neurocognitive impairment using validated tools Day 90
Primary Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19 Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood samples Change from baseline biomarker levels at day 28
Primary Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Assessment of the neurocognitive performance of patients using validated tests (e.g. Short Blessed Test) Day 90
Primary Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Assessment of the change in the neurocognitive performance of patients using validated tests (e.g. IQCODE) Change from baseline IQCODE results at day 90
Secondary Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge Assessment of the overall quality of life using validated tests [e.g. Modified Rankin Scale with a range from 0 (no symptoms) to 6 (dead)] Day 90
Secondary Length of hospital stay in patients with COVID-19 compared to patients without COVID-19 Cumulative days in hospital 1 year
Secondary 90-day survival in patients with COVID-19 compared to patients without COVID-19 Survival after 90 days Day 90
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure