Primary objective: To investigate the prevalence of SARS-CoV-2 presence in the cerebrospinal fluid (CSF) of patients with a proven SARS-CoV-2 infection and acute respiratory failure.Secondary objectives: 1. To correlate the presence of SARS-CoV-2 in…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
SARS-CoV-2 RT-PCR of cerebrospinal fluid (positive/negative)
Secondary outcome
Clinical characteristics
- 8-week mortality
Biochemistry and cell count of the cerebrospinal fluid
- Leukocyte count of the cerebrospinal fluid, including differential count
Biochemistry and cell count of serum
- Leukocyte count
- C-reactive protein (CRP)
- Lactate dehydrogenase (LDH)
- D-Dimer
Background summary
COVID-19 is caused by the SARS-CoV-2 virus, which shares 79% homology with the
SARS-CoV virus, known for the SARS epidemic in 2002/2003. (Wu 2020) Both
viruses are a member of the coronavirus subfamily. (Wu 2020) The clinical
presentation of COVID-19 and SARS show a lot of similarities. Both viruses
cause a viral pneumonia with the most frequent symptoms being fever, coughing,
dyspnoea, myalgia and fatigue. (Huang 2020; Hui 2003)
Typically, a COVID-19 patient will show mild symptoms for several days, after
which the disease either is self-limiting, or evolves into acute respiratory
failure. (Huang 2020) As of yet, the pathophysiology of this last symptom has
not been fully uncovered. Neuroinvasion may play a key part, as it is a known
characteristic of coronaviruses. (Desforges 2014) The presence of SARS-CoV in
the brain has been proven by autopsy, although the studies did not specify from
what part of the brain the biopsies were taken. (Hui 2003; Gu 2005) Research in
mice primarily showed the brain stem being affected by infection of SARS-CoV,
sometimes before demonstrable pulmonary involvement. (McCray 2007, Netland
2005) In one case report, SARS-CoV was detected in the cerebrospinal fluid of a
patient with neurologic symptoms. (Hung et al 2003) On the basis of these
findings it was hypothesised by Li 2020 and later by Baig 2020 that SARS-CoV-2
might also migrate to the brain.
Study objective
Primary objective: To investigate the prevalence of SARS-CoV-2 presence in the
cerebrospinal fluid (CSF) of patients with a proven SARS-CoV-2 infection and
acute respiratory failure.
Secondary objectives:
1. To correlate the presence of SARS-CoV-2 in the CSF with routine biochemistry
of serum and CSF.
2. To correlate the presence of SARS-CoV-2 in the CSF to clinical presentation.
3. To correlate the presence of SARS-CoV-2 in the CSF to 8-week mortality.
4. To investigate the presence of abnormalities in routine CSF biochemistry in
patients with a proven SARS-CoV-2 infection and acute respiratory failure.
Study design
Single-centre pilot study
Study burden and risks
All patients will be exposed to the complications and discomfort associated
with diagnostic lumbar puncture, which is considered a low-risk procedure. As
patients will be sedated during the procedure, they will not experience
periprocedural discomfort. The study is considered group-related as uncovering
the pathophysiology of acute respiratory distress in COVID-19 patients may be a
starting point for research aimed at improving the prognosis of COVID-19
patients.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
Inclusion criteria
- At least 18 years of age
- Requires mechanical ventilation
- Proven SARS-CoV-2 infection
- Lumbar puncture possible within 48 hours of ICU admission
- Informed consent provided by either patient or legal representative
Exclusion criteria
- Any contraindication for lumbar puncture
- Proven or suspected cerebrospinal fluid leak or other blood-brain barrier
defects
- Any condition known to alter cerebrospinal fluid biochemistry
- Known or suspected cause for respiratory failure, other than COVID-19
- Any disease known for decreasing pulmonary capacity or compliance
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL73739.096.20 |