Predict Adverse Events by Covid-19 Nephritis

Covid-19 Clinical Trial

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

Status Completed

Clinical 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 patients as well as can guide preventive strategies.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Covid-19
• Nephritis

• NCT number: NCT04347824
• Study type: Observational
• Source: University Hospital Goettingen
• Status: Completed
• Start date: April 27, 2020
• Completion date: March 31, 2021