Predict Adverse Events by Covid-19 Nephritis

April 27, 2021 updated by: Prof. Dr. O. Gross, University Hospital Goettingen

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

223

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany
        • University Medical Center Goettingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This observational study investigates the outcome of patients with approved Covid-19 diagnosis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

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 * 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during first 10 days after admission to hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during first 10 days after admission to hospital
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)
during hospital stay, up to 2 months
Blood-test
Time Frame: during hospital stay, up to 2 months
  • lowest serum-albumin
  • lowest antithrombin III
during hospital stay, up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Goettingen

Collaborators

Universitätsklinikum Hamburg-Eppendorf
University Hospital, Aachen
Transplantationszentrum Köln-Merheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 13, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMG_Co19-Nephritis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Quesionnaires will be faxed to principal investigator and be analyzed by the department of medical statistics.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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