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Predict Adverse Events by Covid-19 Nephritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347824
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborators:
Universitätsklinikum Hamburg-Eppendorf
University Hospital, Aachen
Transplantationszentrum Köln-Merheim
Information provided by (Responsible Party):
Prof. Dr. O. Gross, University Hospital Goettingen

Brief 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 patients as well as can guide preventive strategies.

Condition or disease
Covid-19

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

  1. pulmonary interstitial edema, possibly also due to capillary leak/ nephrotic syndrome;
  2. immune-incompetence, due to renal loss of immunoglobulins;
  3. circulatory insufficiency, due to hypalbuminemia (which might explain sudden deaths in the geriatric population);
  4. less response to some medications caused by impaired plasma protein binding of drugs due to hypalbuminemia and renal loss;
  5. 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Covid-19 Associated Nephritis as Early Predictor for Complicated Course of Disease
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Group/Cohort
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
intermediate risk
This group has an abnormal urine status on admission to hospital WITHOUT serum-albumin below 2.0 g/dl AND WITHOUT urine-albumin above 5g/gCreatinine 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 urine-albumin above 5g/gCreatinine OR antithrombin III level below 70%.



Primary Outcome Measures :
  1. Disease-Aggrevation [ Time Frame: during first 10 days after admission to hospital ]

    Disease-Aggrevation is defined as

    1. Need of transferral of normal ward to Intermediate Care Unit OR
    2. Need of transferral from Intermediate Care Unit to ICU OR
    3. Need of mechanical Ventilation OR
    4. Need for renal replacement therapy OR
    5. Death.


Secondary Outcome Measures :
  1. Complications [ Time Frame: during first 10 days after admission to hospital ]
    Complications are defined as all other events reported by investigators (despite the primary end-point meassurements)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This observational study investigates the outcome of patients with suspected or approved Covid-19 diagnosis.
Criteria

Inclusion Criteria:

  1. suspected or approved Covid-19 diagnosis (by PCR or CT-scan);
  2. urine status on day of admission (or day after admission)
  3. Patient expressed willingness to participate in observational studies during hospital admission.

Exclusion Criteria:

1) Patient expressed unwillingness to participate in observational studies during hospital admission.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347824


Locations
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Germany
University Medical Center Goettingen Recruiting
Göttingen, Germany
Contact: Oliver Gross, MD    +49-551-39 ext 0    gross.oliver@med.uni-goettingen.de   
Sponsors and Collaborators
University Hospital Goettingen
Universitätsklinikum Hamburg-Eppendorf
University Hospital, Aachen
Transplantationszentrum Köln-Merheim
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Responsible Party: Prof. Dr. O. Gross, Professor, University Hospital Goettingen
ClinicalTrials.gov Identifier: NCT04347824    
Other Study ID Numbers: UMG_Co19-Nephritis
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Quesionnaires will be faxed to principal investigator and be analyzed by the department of medical statistics.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephritis
Kidney Diseases
Urologic Diseases