Recruiting

Biomarkers

Sponsor:

University of British Columbia

Code:

NCT04363008

Conditions

COVID 19

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

serum inflammatory biomarkers

Study Details

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

Study ID

NCT04363008

Start date

Mar 30, 2020

Status verified date

Nov, 2023

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Sep 30, 2022

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Those who do not meet inclusion criteria

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

serum inflammatory biomarkers

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

Primary outcome measure

  • Inflammation [ Time Frame: 24 hours ]
  • Oxygenation [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

Nov 29, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-11-29.