- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04366882
Minimal Invasive Autopsies to Investigate Changes in Deceased COVID-19 Patients (MIA-COVID-19)
Increasing Our Understanding of COVID-19: Minimal Invasive Autopsies to Investigate Clinical, Radiological, Microbiological and Histopathological Changes in Deceased COVID-19 Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hasselt, Belgium
- Jessa hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of cause of death and contributing factors based on clinical, radiological, microbiological and histopathological data of the deceased patient
Time Frame: up to one month
|
For each individual patient the cause of death and contributing factors will be assessed. For each individual these diagnoses will be made during a meeting of a multidisciplinary team consisting of at least an infectious diseases physician, a radiologist and a pathologist. On a case to case basis, additional medical specialists can be asked to attend, including an intensive care specialist, a geriatrician and/or a microbiologist. During the meetings, the clinical, radiological, microbiological and histopathological data will be presented to all attending specialists. The final diagnoses will be based on consensus. Outcomes will be reported as proportions with a 95% confidence interval. |
up to one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detailed description of the postmortem radiological changes induced by COVID-19
Time Frame: up to one month
|
The radiological findings will be systematically scored as absent or present.
These findings will be reported as proportions with a 95% confidence interval.
|
up to one month
|
Detailed description of the postmortem histopathological changes induced by COVID-19
Time Frame: up to one month
|
On the basis of clinical observations at this moment in time correlations will be done between the renal histology findings of the patients with and without renal failure at death as well as between the cardiac histology findings of the patients with and without clinical signs of myocarditis.
However, in the light of continuous clinical observations and new insights, this may be expanded in the future.
Outcomes will be reported as proportions with a 95% confidence interval.
|
up to one month
|
Postmortem quantity of viral RNA
Time Frame: up to one month
|
Describe the quantity of viral RNA in the different tissues and relate this to the clinical, radiological and histopathological findings.
|
up to one month
|
Postmortem disease mechanisms at cellular level
Time Frame: up to one month
|
Study in detail the disease mechanisms at cellular level (including ACE-2 receptor expression in relation to quantity of viral RNA) in the different tissues.
|
up to one month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Janneke Cox, MD, PhD, Jessa hospital
Publications and helpful links
General Publications
- 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. Erratum In: Nat Commun. 2022 Oct 21;13(1):6247.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JessaH_COVID-19_MIA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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