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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. Read our disclaimer for details. Identifier: NCT04347824
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : April 28, 2021
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

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
Actual Enrollment : 223 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
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

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%.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Complications [ Time Frame: during first 10 days after admission to hospital ]

    Number of Complications are defined as

    1. Need of transferral to "ICU low" (ICU level 1)*
    2. Need of transferral to "ICU high" (ICU level 3)*
    3. Need of mechanical ventilation* OR
    4. Need for renal replacement therapy* OR
    5. Need of extracorporeal membrane oxygenation* OR
    6. Death * in the first 10 days after admission to hospital

  2. Resources [ Time Frame: during hospital stay, up to 2 months ]
    • 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)

  3. Blood-test [ Time Frame: during hospital stay, up to 2 months ]
    • lowest serum-albumin
    • lowest antithrombin III

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 approved Covid-19 diagnosis.

Inclusion Criteria:

  1. approved Covid-19 diagnosis (by PCR or CT-scan);
  2. urine status during hospital stay
  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 identifier (NCT number): NCT04347824

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University Medical Center Goettingen
Göttingen, Germany
Sponsors and Collaborators
University Hospital Goettingen
Universitätsklinikum Hamburg-Eppendorf
University Hospital, Aachen
Transplantationszentrum Köln-Merheim
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. O. Gross, Professor, University Hospital Goettingen Identifier: NCT04347824    
Other Study ID Numbers: UMG_Co19-Nephritis
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
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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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Kidney Diseases
Urologic Diseases