Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05200819 |
Other study ID # |
HUM00186076 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 2, 2020 |
Est. completion date |
February 20, 2023 |
Study information
Verified date |
December 2023 |
Source |
University of Michigan |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
All surviving patients of the Michigan Medicine COVID-19 Cohort (M2C2, PI: Hayek) that were
admitted to the University of Michigan for severe COVID-19 disease are eligible for this
study. Investigators had prior approval from the Institutional Review Board (IRB) to collect
the baseline blood and urine samples of these participants. Initial analysis on those samples
are ongoing. In preliminary analysis of these patients a significantly higher risk for severe
acute complications in patients with diabetes compared to those without diabetes was
observed. The study will also enroll people following documented COVID-19 infection,
regardless of whether or not they were hospitalized. The goal of the study is to understand
what drives the increased risk of severe acute COVID-19 complications as well as to
understand the long term sequelae of COVID-19 infection in patients with diabetes. The
objectives of this study are to invite surviving M2C2 participants as well as others who have
survived COVID-19 infection for an in-person visit, to measure biomarkers of inflammation and
kidney, nerves, heart and blood vessels damage. participants will also be comprehensively
phenotyped for diabetic complications outcomes, diabetes kidney disease, diabetes neuropathy
and cardiovascular disease. Participants will be asked to fill out questionnaires to assess
psychosocial metrics. The rationale is that correlating markers of acute hyperinflammation
(cytokine storm syndrome) at admission in diabetes patients can inform vigilance and care for
long term complications in survivors. Completing these studies will generate evidence-based
guidelines for mitigating sequelae in diabetes COVID-19 survivors and identify critical
psychosocial factors to mitigate psychological harm.
Description:
Diabetic patients, particularly those with type 2 diabetes (T2D), are highly susceptible to
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) induced adverse outcomes and
complications. The massive global T2D burden and high COVID-19 infection rate is creating
large and significantly vulnerable COVID-19 T2D patient populations.
The prevalence of diabetes among admitted COVID-19 infections has varied 20-50% by region.T2D
patients are more prone to a severe COVID-19 disease course, marked by dangerous
infection-induced adverse outcomes and complications including intensive care unit (ICU)
admission, mechanical ventilation use, or death. The clinical experience with patients
admitted to the Michigan Medicine COVID-19 Cohort (M2C2, PI: Hayek): 42% of COVID-19 cases
had diabetes, and a disproportionally larger fraction, 56%, required ICU admittance and
suffered over twice the mortality (22%) compared to non-diabetic (10%) patients. Thus, T2D
consistently predisposes COVID-19 patients to poorer prospects, including acute kidney
injury, cardiovascular complications and death.
Most T2D patients frequently suffer from comorbidities, including metabolic syndrome
(obesity, hypertension), chronic inflammation, and vascular diabetic complications, i.e.,
diabetic kidney disease (DKD), diabetic neuropathy (DN), and cardiovascular disease (CVD). In
the multi-center French Coronavirus SARS-CoV-2 and Diabetes Outcomes (CORONADO) study
(n=1,317 diabetic participants, 88.5% T2D), obesity, measured by body mass index (BMI)
positively predicted the study primary outcome, tracheal intubation for mechanical
ventilation and/or death within 7 days of admission. The presence of micro- and macrovascular
complications at admission independently associated with 7-day mortality, as did inflammation
[C-reactive protein (CRP)]and liver injury at admission. Thus, T2D patients, through their
comorbid conditions, are at an especially dangerous risk of serious COVID-19 infection and
death.
The underlying reasons for the T2D patient susceptibility to COVID-19 remains unclear,
although there are several theories. One is that COVID-19-induced cytokine storm syndrome
(CSS) may superimpose on the chronic inflammation already present in T2D, promoting a vicious
cycle of cytokine release and hyperglycemic surges. T2D is characterized by a chronic,
low-grade inflammation, which is also a feature of its complications, DKD, DN, and CVD.
Importantly, there are no studies stratifying patients by diabetes status to determine
whether a biomarker would be especially useful for predicting the clinical course in COVID-19
T2D patients.
It is also becoming clear that COVID-19 survivors may face a lifetime of sequelae. As with
acute infection, T2D patients may also be particularly at risk here. Although the pandemic
has not yet lasted long enough to measure long term outcomes, the evidence to date suggests a
significant burden of new complications. For instance, COVID-19 may aggravate preexisting
pathology, including in T2D patients, and multi-organ injury that aggravates tissues already
weakened by preexisting diabetic complications. Finally, the COVID-19 pandemic has seen
racial health disparities soar. SARS outbreak survivors report long term effects, even years
later, including psychological and financial hardship. In addition, given the disparity
during the COVID-19 pandemic, racial minorities faced even more hardships. Identifying these
psychosocial factors could mitigate long term psychological trauma. The challenges of the
long-term consequences of COVID-19 are emerging as a growing number of patients are long-term
survivor sequelae. Identifying these COVID-19 patients who experienced serious clinical
complications during their inpatient hospitalization and then sequelae after the acute phase,
will deliver better long term outpatient care and allow to preemptively screen for new onset
and progression in all complications.