Counter-Regulatory Hormonal and Stress Systems in Patients With COVID-19

NCT05736900 | Completed

• 1 other identifier: 3223
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 pandemic is associated with a highly variable presentation, ranging from patients who are asymptomatic or experience only mild symptoms to others with acute respiratory syndrome (ARDS) who require ventilatory support and carry a high risk of severe adverse outcomes and mortality. The most vulnerable population are older adults, usually people with chronic medical conditions and more often men than women.. Nevertheless, infection with SARS-CoV-2 can have deadly consequences even among those without any clear pre-existing medical conditions. Differences in adaptive immune responses and ensuing inflammatory reactions are proposed to contribute to the variable vulnerability to severe disease among patients infected with SARS-CoV-19. It is also possible that inter-individual differences in responsiveness of counter-regulatory hormonal and stress systems may further contribute to variable outcomes in infected patients, and that this may involve modulation of inflammatory responses. The hypothalamo-pituitary adrenal (HPA) axis in particular is a critical regulator of adaptive responses of metabolic and immune systems to various stressors, including. Sex-differences and age-related declines in adrenal cortical production of glucocorticoids and androgens as well as responsiveness of the HPA axis and immune function to stressors are particularly in older men. Such factors may contribute to the high morbidity associated with SARS-CoV-2 infection in elderly males.Among other important hormonal counter-regulatory systems, the renin angiotensin aldosterone system (RAAS) is prominently and directly impacted by SARS-CoV-2. Specifically both SARS-CoV-2 and SARS-CoV angiotensin-converting enzyme 2 (ACE2) to gain entry into cells. Tissue distrubtions of ACE2 match to viral distributions and systemic-wide impacts of SARS-CoV-2 or SARS-CoV beyond the lungs to kidneys, pancreas heart and other tissues. Studies in rats have shown that ACE2 is expressed in substantially higher amounts in alveolar epithelium, bronchiolar epithelium, endothelium and smooth muscle cells of pulmonary vessels of younger than older animals and among the latter group in higher amounts in females than males. Should the same apply to humans such differences may underly the predominance of symptomatic and more severe infections with both SARS-CoV-2 and SARS-CoV in older than younger patients, particularly male

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• measure of the clinical status of patients at long-term follow up

  This will be based on a composite cardiovascular and metabolic score that takes into account multiple clinical conditions known to be associated with SARS-CoV2 and SARS-CoV infections and hypothesized to be further worsened be infections. We will evaluate these scores using an established and widely implemented metabolic syndrome (MetS) severity Z-score (http://mets.health-outcomes-policy.ufl.edu). Clinical conditions will include diabetes mellitus, hypertension, ischemic heart disease, pulmonary disorders and any associated clinical complications that develop after infection (e.g., stroke, cardiac failure, death).

  1 year

Study Arms (1)

Patients with COVID-19

OTHER

Patients admitted as in-patients with SARS-CoV-2 Infection

Diagnostic Test: Blood sampling

Interventions

Blood sampling DIAGNOSTIC_TEST

One samples of 5 mL blood is taken into a Serum tube for measurement of the RAAS-Biomarkers. After allowing to coagulate between 30 min and 60 min at room temperature, samples are centrifuged at 3000g for 10 min at room temperature.

Patients with COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age \> 18 years)
• Patients who meet on one or more of the following criteria for the screening test according to the CDC guidelines:
• Have fever or lower respiratory symptoms (cough, shortness of breath) and close contact with a confirmed COVID-19 case within the past 14 days; OR Have fever and lower respiratory symptoms (cough, shortness of breath) and a negative rapid flu test
• Patients with previous documented history of SARS-CoV-2 infection withn appropriate retrospectively collected andv available data.

You may not qualify if:

• Patients with impaired mental capacity that precludes informed consent
• Subjects who need medications that may interfere with or invalidate outcome parameters and that can not be stopped without significant risk (e.g., steroids, oral contraceptives)
• Severe or terminal co-morbidity which seriously interferes with possible treatment or health related quality of life
• Pregnancy

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Mingrone Geltrude

Roma, 00188, Italy

Location

Related Publications (4)

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• Li G, Fan Y, Lai Y, Han T, Li Z, Zhou P, Pan P, Wang W, Hu D, Liu X, Zhang Q, Wu J. Coronavirus infections and immune responses. J Med Virol. 2020 Apr;92(4):424-432. doi: 10.1002/jmv.25685. Epub 2020 Feb 7.

  PMID: 31981224 BACKGROUND

• Bornstein SR, Dalan R, Hopkins D, Mingrone G, Boehm BO. Endocrine and metabolic link to coronavirus infection. Nat Rev Endocrinol. 2020 Jun;16(6):297-298. doi: 10.1038/s41574-020-0353-9.

  PMID: 32242089 BACKGROUND

• Sternberg EM, Chrousos GP, Wilder RL, Gold PW. The stress response and the regulation of inflammatory disease. Ann Intern Med. 1992 Nov 15;117(10):854-66. doi: 10.7326/0003-4819-117-10-854.

  PMID: 1416562 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• geltrude mingrone

  Policlinico A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: February 21, 2023
• Study Start: September 10, 2020
• Primary Completion: February 9, 2021
• Study Completion: June 12, 2021
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

IT (1)