Predict Adverse Events by Covid-19 Nephritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-27

Study Completion Date

2021-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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%.

No interventions assigned to this group

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%.

No interventions assigned to this group

Eligibility Criteria

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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.