Investigating the Role of Biomarkers in Predicting Outcome for COVID 19

NCT04363008 | Unknown

• 1 other identifier: H20-00971
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Emergent experimental and anecdotal evidence has indicated that critically ill COVID-19 patients demonstrate two patient sub-types (called phenotypes). In one group the disease progresses slowly and patients have a low potential of developing mild respiratory failure, but in the other group, an exaggerated immune response (hyper-inflammation/cytokine storm) may be linked to the onset of precipitous respiratory failure, termed acute respiratory distress syndrome. This syndrome is responsible for a large portion of COVID-19 associated mortality. Thus, determining links between hyper-inflammation and acute respiratory distress syndrome in COVID-19 patients is of immediate importance. Blood samples will undergo a number of analyses to help us to understand as much as possible about COVID-19. We will also study any differences in physiologic and cytokine levels before and after patients are treated with immunomodulatory therapies as part of clinical care in COVID-19 patients.

Conditions

COVID 19

Outcome Measures

Primary Outcomes (2)

• Inflammation

  Interleukin 1b, 6, 10 and tumor necrosis factor alpha

  24 hours

• Oxygenation

  Ratio of arterial oxygen tension (mmHg) to fraction of inspired oxygen (PaO2/FiO2)

  24 hours

Secondary Outcomes (4)

• Chronic Pulmonary outcomes

  8 to 12 weeks after discharge

• Pulmonary artery pressure using transthoracic echocardiography

  8 to 12 weeks after discharge

• Exertion

  8 to 12 weeks after discharge

• Quality of life assessment

  8 to 12 weeks after discharge

Other Outcomes (1)

• Duration of mechanical ventilation

  30 days

Interventions

serum inflammatory biomarkers DIAGNOSTIC_TEST

Serum biomarkers measured (IL-1 beta, IL-2, IL-6, IL-10, TNF alpha)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to ICU with COVID 19.

You may qualify if:

• Patients admitted to VGH or SMH with confirmed COVID-19
• Admitted to the High Acuity Unit or Intensive Care Unit at VGH or SMH
• An arterial line is in place as part of clinical care. If arterial line is on longer insitu the sample will be collected to coincide with usual care blood collection. This will negate the need for additional venipuncture

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Genetic Testing: We and others have shown that host genetic differences have a significant impact on the clinical outcomes of sepsis. For instance, we have shown that a single nucleotide variant in the CETP gene more than doubles the risk of 28-day mortality from sepsis. We hypothesize that similar to other forms of critical illness, host gene variation will also influence the clinical outcome from COVID-19 infection. Our research is designed to elucidate the impact of genetic variation on clinical outcomes from COVID-19.

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Mypinder Sekhon, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mypinder Sekhon, MD

CONTACT

6048754111; mypindersekhon@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 27, 2020
• Study Start: March 30, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CA (1)