Clinical trial NCT04366882: Minimal Invasive Autopsies to Investigate Changes in Deceased COVID-19 Patients
Official title: Increasing Our Understanding of COVID-19: Minimal Invasive Autopsies to Investigate Clinical, Radiological, Microbiological and Histopathological Changes in Deceased COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
cause of death
pathophysiology
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
Collaborators: name: Hasselt University
name: University Hospital, Antwerp
First posted: 2020-04-29
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Rationale In a very short time corona virus disease 2019 (COVID-19) has become a pandemic with high morbidity and mortality. The main cause of death is respiratory failure including acute respiratory distress syndrome, however the exact mechanisms and other underlying pathology is currently not yet known. In the current setting of the COVID-19 pandemic complete autopsies seem too risky due to the risk of SARS CoV-2 transmission. Yet, as so little is known, additional histopathological, microbiological and virologic study of tissue of deceased COVID-19 patients will provide important clinical and pathophysiological information. Minimal invasive autopsy combined with postmortem imaging seems therefore an optimal method combining safety on the one hand yet proving significant information on the other.

This study aims to determine the cause of death and attributable conditions in deceased COVID-19 patients. This will be performed using post-mortem CT-scanning plus CT-guided MIA to obtain tissue for further histological, microbiological and pathological diagnostics. In addition, the pathophysiology of COVID-19 will be examined by further tissue analysis.


Eligibility criteria: Inclusion Criteria:

* All patients with COVID-19 that die during hospitalization in Jessa hospital. COVID-19 is defined as either a positive SARS CoV-2 PCR result OR a high clinical suspicion combined with typical radiologic findings in the absence of an alternative explanation for the clinical picture.

Exclusion Criteria:

* None

Primary outcomes:
measure: Determination of cause of death and contributing factors based on clinical, radiological, microbiological and histopathological data of the deceased patient
timeFrame: up to one month
Secondary outcomes:
measure: Detailed description of the postmortem radiological changes induced by COVID-19
timeFrame: up to one month
measure: Detailed description of the postmortem histopathological changes induced by COVID-19
timeFrame: up to one month
measure: Postmortem quantity of viral RNA
timeFrame: up to one month
measure: Postmortem disease mechanisms at cellular level
timeFrame: up to one month
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
affiliation: Jessa Hospital
name: Janneke Cox, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Cleemput J, van Snippenberg W, Lambrechts L, Dendooven A, D'Onofrio V, Couck L, Trypsteen W, Vanrusselt J, Theuns S, Vereecke N, van den Bosch TPP, Lammens M, Driessen A, Achten R, Bracke KR, Van den Broeck W, Von der Thusen J, Nauwynck H, Van Dorpe J, Gerlo S, Maes P, Cox J, Vandekerckhove L. Organ-specific genome diversity of replication-competent SARS-CoV-2. Nat Commun. 2021 Nov 16;12(1):6612. doi: 10.1038/s41467-021-26884-7.
citation: D'Onofrio V, Donders E, Vanden Abeele ME, Dubois J, Cartuyvels R, Achten R, Lammens M, Dendooven A, Driessen A, Augsburg L, Vanrusselt J, Cox J. The clinical value of minimal invasive autopsy in COVID-19 patients. PLoS One. 2020 Nov 11;15(11):e0242300. doi: 10.1371/journal.pone.0242300. eCollection 2020.