Covid-19NCT04347824
Predict Adverse Events by Covid-19 Nephritis
An observational study of Covid-19, run by University Hospital Goettingen at 1 site in Germany.
Trial summary
This non-interventional, observational study retrospectively (and in parts prospectively) investigates, if a Covid-19 associated Nephritis, diagnosed by Urine-dipstick and further Urine-analyses on addmission, can help to predict later complications, adverse outcomes and later need for ICU-capacity in Covid-19… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid-19
- How many people
- 223 participants
- Where
- 1 siteGermany
- Study dates
- 27 Apr 2020to 31 Mar 2021
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This observational study investigates the outcome of patients with approved Covid-19 diagnosis.
Who may be able to join
- approved Covid-19 diagnosis (by PCR or CT-scan);
- urine status during hospital stay
- Patient expressed willingness to participate in observational studies during hospital admission.
Who cannot join
- 1) Patient expressed unwillingness to participate in observational studies during hospital admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Covid-19 Associated Nephritis as Early Predictor for Complicated Course of Disease
This non-interventional, observational study retrospectively (and in parts prospectively) investigates, if a Covid-19 associated Nephritis, diagnosed by Urine-dipstick and further Urine-analyses on addmission, can help to predict later complications, adverse outcomes and later need for ICU-capacity in Covid-19 patients as well as can guide preventive strategies.
Read the detailed description
Parameters predicting risks for Covid-19 patients are urgently sought. The current study investigates, if Covid-19 associated nephritis indicating systemic cappillary leak syndrome/severe nephrotic syndrome could be the major driver for complications, predictor for respiratory failure and later need for ICU, and death.
This study intends to generate an algorithm for University hospitals, which allows early detection of Covid-19 associated nephritis and to classify the risk for respiratory decompensation by quantification of severity of nephrotic syndrome.
The rationale of the observational study can be explained by the hypothesis that Covid-19 causes Nephritis: Podocytes express high levels of ACE2, which makes the glomerulus to a target for Covid-19. Other zoonoses, such as Hanta-virus, are a well described cause of nephrotic syndrome inducing cardiopulmonary syndrome. Life-threatening complications of severe nephrotic syndrome are well known as are preventive therapies.
Covid-19 ICU patients with nephritis have
- pulmonary interstitial edema, possibly also due to capillary leak/ nephrotic syndrome;
- immune-incompetence, due to renal loss of immunoglobulins;
- circulatory insufficiency, due to hypalbuminemia (which might explain sudden deaths in the geriatric population);
- less response to some medications caused by impaired plasma protein binding of drugs due to hypalbuminemia and renal loss;
- thromboembolic events, due to antithrombin-deficiency (which might explain lethality in oligo-symptomatic young patients).
In conclusion, ACE2 in the respiratory tract is the gateway for Covid-19 for infection, however, the study postulates that Covid-19 associated nephritis and severe cappillary leak/nephrotic syndrome is a major driver of adverse outcome. If confirmed by others, these findings and algorithm would allow early prediction of later need for ICU-capacity, better allocation of patients for clinical trials, and preventive strategies focused on the nephrotic syndrome including treatment, which can save lives. Same might apply for risk-evaluation of outpatients.
- Conditions
- Covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| low risk | This group has a normal urine status on admission to hospital. Abnormal urine status is defined anuric OR as 2* or more of the following findings: 1. urine osmolarity below normal values 2. leukozyturia 3. hematuria 4. albuminuria/ proteinuria * if urine is positive for nitrite or bacteria, abnormal urine status is defined as 3 or more of the findings. | |
| intermediate risk | This group has an abnormal urine status on admission to hospital WITHOUT serum-albumin below 2.0 g/dl AND WITHOUT antithrombin III level below 70%. | |
| high risk | This group has an abnormal urine status on admission to hospital PLUS serum-albumin below 2.0 g/dl OR antithrombin III level below 70%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease-Aggravation
Time (in days) from hospital admission to transferral to ICU (ICU level high) OR time (in days) from Hospital Admission to Death
Measured: during first 10 days after admission to hospital
Secondary outcomes (3)
Complications
Number of Complications are defined as
- Need of transferral to "ICU low" (ICU level 1)*
- Need of transferral to "ICU high" (ICU level 3)*
- Need of mechanical ventilation* OR
- Need for renal replacement therapy* OR
- Need of extracorporeal membrane oxygenation* OR
- Death * in the first 10 days after admission to hospital
Measured: during first 10 days after admission to hospital
Resources
- Time on "ICU low" (in days),
- Time on "ICU high" (in days),
- Time on invasive mechanical ventilation (in days)
- Time on extracorporeal membrane oxygenation (in days)
- Time on renal replacement therapy (in days)
Measured: during hospital stay, up to 2 months
Blood-test
- lowest serum-albumin
- lowest antithrombin III
Measured: during hospital stay, up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start27 Apr 2020
- Primary completion31 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Goettingen
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University Hospital, Aachen, Transplantationszentrum Köln-Merheim
- Responsible party
- Principal investigator, Prof. Dr. O. Gross, University Hospital Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347824
- Sponsor's protocol ID
- UMG_Co19-Nephritis
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Quesionnaires will be faxed to principal investigator and be analyzed by the department of medical statistics.
Publications
Gross O, Moerer O, Weber M, Huber TB, Scheithauer S. COVID-19-associated nephritis: early warning for disease severity and complications? Lancet. 2020 May 16;395(10236):e87-e88. doi: 10.1016/S0140-6736(20)31041-2. Epub 2020 May 6. No abstract available.
PubMed 32423587Puelles VG, Lutgehetmann M, Lindenmeyer MT, Sperhake JP, Wong MN, Allweiss L, Chilla S, Heinemann A, Wanner N, Liu S, Braun F, Lu S, Pfefferle S, Schroder AS, Edler C, Gross O, Glatzel M, Wichmann D, Wiech T, Kluge S, Pueschel K, Aepfelbacher M, Huber TB. Multiorgan and Renal Tropism of SARS-CoV-2. N Engl J Med. 2020 Aug 6;383(6):590-592. doi: 10.1056/NEJMc2011400. Epub 2020 May 13. No abstract available.
PubMed 32402155Gross O, Moerer O, Rauen T, Bockhaus J, Hoxha E, Jorres A, Kamm M, Elfanish A, Windisch W, Dreher M, Floege J, Kluge S, Schmidt-Lauber C, Turner JE, Huber S, Addo MM, Scheithauer S, Friede T, Braun GS, Huber TB, Blaschke S. Validation of a Prospective Urinalysis-Based Prediction Model for ICU Resources and Outcome of COVID-19 Disease: A Multicenter Cohort Study. J Clin Med. 2021 Jul 9;10(14):3049. doi: 10.3390/jcm10143049.
PubMed 34300217
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Associated Nephritis as Early Predictor for Complicated Course of Disease
- ClinicalTrials.gov ID
- NCT04347824
- Acronym / sponsor ID
- UMG_Co19-Nephritis
- Conditions
- Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University Hospital GoettingenUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University Hospital, Aachen, Transplantationszentrum Köln-Merheim
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 15 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.
This non-interventional, observational study retrospectively (and in parts prospectively) investigates, if a Covid-19 associated Nephritis, diagnosed by Urine-dipstick and further Urine-analyses on addmission, can help to predict later complications, adverse outcomes and later need for ICU-capacity in Covid-19 patients as well as can guide preventive strategies.
Detailed description
Parameters predicting risks for Covid-19 patients are urgently sought. The current study investigates, if Covid-19 associated nephritis indicating systemic cappillary leak syndrome/severe nephrotic syndrome could be the major driver for complications, predictor for respiratory failure and later need for ICU, and death.
This study intends to generate an algorithm for University hospitals, which allows early detection of Covid-19 associated nephritis and to classify the risk for respiratory decompensation by quantification of severity of nephrotic syndrome.
The rationale of the observational study can be explained by the hypothesis that Covid-19 causes Nephritis: Podocytes express high levels of ACE2, which makes the glomerulus to a target for Covid-19. Other zoonoses, such as Hanta-virus, are a well described cause of nephrotic syndrome inducing cardiopulmonary syndrome. Life-threatening complications of severe nephrotic syndrome are well known as are preventive therapies.
Covid-19 ICU patients with nephritis have
- pulmonary interstitial edema, possibly also due to capillary leak/ nephrotic syndrome;
- immune-incompetence, due to renal loss of immunoglobulins;
- circulatory insufficiency, due to hypalbuminemia (which might explain sudden deaths in the geriatric population);
- less response to some medications caused by impaired plasma protein binding of drugs due to hypalbuminemia and renal loss;
- thromboembolic events, due to antithrombin-deficiency (which might explain lethality in oligo-symptomatic young patients).
In conclusion, ACE2 in the respiratory tract is the gateway for Covid-19 for infection, however, the study postulates that Covid-19 associated nephritis and severe cappillary leak/nephrotic syndrome is a major driver of adverse outcome. If confirmed by others, these findings and algorithm would allow early prediction of later need for ICU-capacity, better allocation of patients for clinical trials, and preventive strategies focused on the nephrotic syndrome including treatment, which can save lives. Same might apply for risk-evaluation of outpatients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low risk | – | –This group has a normal urine status on admission to hospital. Abnormal urine status is defined anuric OR as 2* or more of the following findings: 1. urine osmolarity below normal values 2. leukozyturia 3. hematuria 4. albuminuria/ proteinuria * if urine is positive for nitrite or bacteria, abnormal urine status is defined as 3 or more of the findings. |
| intermediate risk | – | –This group has an abnormal urine status on admission to hospital WITHOUT serum-albumin below 2.0 g/dl AND WITHOUT antithrombin III level below 70%. |
| high risk | – | –This group has an abnormal urine status on admission to hospital PLUS serum-albumin below 2.0 g/dl OR antithrombin III level below 70%. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This observational study investigates the outcome of patients with approved Covid-19 diagnosis.
Key inclusion criteria (3 listed)
- approved Covid-19 diagnosis (by PCR or CT-scan);
- urine status during hospital stay
- Patient expressed willingness to participate in observational studies during hospital admission.
Key exclusion criteria (1 listed)
- 1) Patient expressed unwillingness to participate in observational studies during hospital admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Disease-Aggravation
Time frame: during first 10 days after admission to hospital
Time (in days) from hospital admission to transferral to ICU (ICU level high) OR time (in days) from Hospital Admission to Death
3 secondary outcomes
Complications
Time frame: during first 10 days after admission to hospital
Resources
Time frame: during hospital stay, up to 2 months
Blood-test
Time frame: during hospital stay, up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 32423587Gross O, Moerer O, Weber M, Huber TB, Scheithauer S. COVID-19-associated nephritis: early warning for disease severity and complications? Lancet. 2020 May 16;395(10236):e87-e88. doi: 10.1016/S0140-6736(20)31041-2. Epub 2020 May 6. No abstract available.
- Background: PubMed 32402155Puelles VG, Lutgehetmann M, Lindenmeyer MT, Sperhake JP, Wong MN, Allweiss L, Chilla S, Heinemann A, Wanner N, Liu S, Braun F, Lu S, Pfefferle S, Schroder AS, Edler C, Gross O, Glatzel M, Wichmann D, Wiech T, Kluge S, Pueschel K, Aepfelbacher M, Huber TB. Multiorgan and Renal Tropism of SARS-CoV-2. N Engl J Med. 2020 Aug 6;383(6):590-592. doi: 10.1056/NEJMc2011400. Epub 2020 May 13. No abstract available.
- Derived from this study: PubMed 34300217Gross O, Moerer O, Rauen T, Bockhaus J, Hoxha E, Jorres A, Kamm M, Elfanish A, Windisch W, Dreher M, Floege J, Kluge S, Schmidt-Lauber C, Turner JE, Huber S, Addo MM, Scheithauer S, Friede T, Braun GS, Huber TB, Blaschke S. Validation of a Prospective Urinalysis-Based Prediction Model for ICU Resources and Outcome of COVID-19 Disease: A Multicenter Cohort Study. J Clin Med. 2021 Jul 9;10(14):3049. doi: 10.3390/jcm10143049.
- Individual participant dataSharing planned: Undecided. Quesionnaires will be faxed to principal investigator and be analyzed by the department of medical statistics.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by University Hospital Goettingen at 1 site in Germany.
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 3 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: finished, as of the sponsor's last update on 28 Apr 2021. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to Disease-Aggravation (time frame: during first 10 days after admission to hospital). 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 NCT04347824, which also lists 3 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 28 Apr 2021.