Skip to main content
OpenTrials
Completed

NCT Number: NCT04347824

Predict Adverse Events by Covid-19 Nephritis

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Goettingen

Göttingen, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Complications

    Time frame: during first 10 days after admission to hospital

    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
  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

Sponsors and collaborators

Lead sponsor

University Hospital Goettingen

Other

Collaborators

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

Registry information

Official study title

Covid-19 Associated Nephritis as Early Predictor for Complicated Course of Disease

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 15, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.