COVID-19MIA-COVID-19NCT04366882
Minimal Invasive Autopsies to Investigate Changes in Deceased COVID-19 Patients
A study testing CT-scan with minimal invasive autopsy in people with COVID-19, run by Jessa Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- CT-scan with minimal invasive autopsy
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Apr 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- CT-scan with minimal invasive autopsy
- Keywords
- COVID-19, cause of death, pathophysiology
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-scan with minimal invasive autopsyProcedure or surgery
CT-guided biopsies will be performed directly following the diagnostic CT-scan. Biopsies will be taken from heart, liver, lungs, spleen, kidneys and abdominal fat according to a standard operation procedure. Biopsies will be taken for further histological examination and storage in the biobank. Of the lung, additional samples will be taken for microbiological examination. Additional samples will be taken in case of (focal) abnormalities on CT-imaging. In case of pleural, cardiac or abdominal fluid, this will be aspirated for further cytological, biochemical and microbiological examination. Finally, 15 cc blood will be drawn from the heart.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of cause of death and contributing factors based on clinical, radiological, microbiological and histopathological data of the deceased patient
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.
Measured: up to one month
Secondary outcomes (4)
Detailed description of the postmortem radiological changes induced by COVID-19
The radiological findings will be systematically scored as absent or present. These findings will be reported as proportions with a 95% confidence interval.
Measured: up to one month
Detailed description of the postmortem histopathological changes induced by COVID-19
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.
Measured: up to one month
Postmortem quantity of viral RNA
Describe the quantity of viral RNA in the different tissues and relate this to the clinical, radiological and histopathological findings.
Measured: up to one month
Postmortem disease mechanisms at cellular level
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.
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start14 Apr 2020
- Primary completion31 Dec 2020
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University, University Hospital, Antwerp
- Responsible party
- Sponsor
- Investigators
- Janneke Cox, MD, PhD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366882
- Sponsor's protocol ID
- JessaH_COVID-19_MIA
- Acronym
- MIA-COVID-19
- Status last verified
- Aug 2022
- First submitted
- 22 Apr 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34785663D'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.
PubMed 33175911
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Our Understanding of COVID-19: Minimal Invasive Autopsies to Investigate Clinical, Radiological, Microbiological and Histopathological Changes in Deceased COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04366882
- Acronym / sponsor ID
- MIA-COVID-19 / JessaH_COVID-19_MIA
- Conditions
- COVID-19
- Keywords
- COVID-19, cause of death, pathophysiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Collaborators
- Hasselt University, University Hospital, Antwerp
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-scan with minimal invasive autopsyCT-guided biopsies will be performed directly following the diagnostic CT-scan. Biopsies will be taken from heart, liver, lungs, spleen, kidneys and abdominal fat according to a standard operation procedure. Biopsies will be taken for further histological examination and storage in the biobank. Of the lung, additional samples will be taken for microbiological examination. Additional samples will be taken in case of (focal) abnormalities on CT-imaging. In case of pleural, cardiac or abdominal fluid, this will be aspirated for further cytological, biochemical and microbiological examination. Finally, 15 cc blood will be drawn from the heart. | Procedure or surgery | – |
Primary outcome
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.
4 secondary outcomes
Detailed description of the postmortem radiological changes induced by COVID-19
Time frame: up to one month
Detailed description of the postmortem histopathological changes induced by COVID-19
Time frame: up to one month
Postmortem quantity of viral RNA
Time frame: up to one month
Postmortem disease mechanisms at cellular level
Time frame: up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Derived from this study: PubMed 34785663Van 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.
- Derived from this study: PubMed 33175911D'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janneke Cox, MD, PhD principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-scan with minimal invasive autopsy in people with COVID-19, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366882, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.