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Immune Profiling of COVID19-patients Admitted to ICU

Immune Profiling of COVID-19-infected Patients Admitted to the Intensive Care Unit (ICU): the IMPROVISE Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04473131
Acronym
IMPROVISE
Enrollment
300
Registered
2020-07-16
Start date
2020-04-27
Completion date
2022-06-30
Last updated
2020-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, SARS-CoV-2, ICU, Immune profiling, Humoral immunity, Cellular immunity

Brief summary

SARS-CoV-2 is the novel coronavirus responsible for COVID-19, coronavirus disease 2019. This new coronavirus was first detected in Wuhan, China in late December 2019. According to WHO, the incidence rate of COVID-19 is prominent among adults and elderly people, reaching so far \>2 million cases globally. Meanwhile, confirmed death cases reached \>126 thousands of reported cases in 185 countries and still increasing. We anticipate that immunological differences among COVID19-infected patients might be a reason behind the variation of patient outcomes. Therefore, we intend to investigate cellular and humoral immune responses of COVID19-positive patients, and we claim to discover new indicators of patients' prognosis. Our target population includes three categories of patients staying at ICU, HMC (COVID19-positive vs. COVID19-negative vs. healthy control). Throughout their ICU stay, multiple blood samples will be screened for leukocytes surface markers, leukocytes' production of certain molecules, and circulating cytokines/chemokines/checkpoint inhibitors. Their plasma/serum will be used as well for immune proteomics, metabolomics, and other serological tests. Such parameters can provide the more comprehensive status of COVID19-infected patients at infection onset, during treatment intake, and at recovery or relapse stage. Following analysis, the main prospective outcome of this study is to identify the most reflective markers of COVID19-positive patients' outcomes.

Interventions

OTHERNo intervention

Only blood samples will be taken from participants for this study

Sponsors

Qatar University
CollaboratorOTHER
Weill Cornell Medical College in Qatar
CollaboratorOTHER
Hamad Medical Corporation
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Admitted to ICU for suspicious COVID-19 * Signed consent form

Exclusion criteria

* Immuno-compromised or immuno-deficient patients * Diagnosed with any immunological disorders, cancer, and onco-hematological diseases at the inclusion date * Patients under treatment or treated within 5 years before inclusion or at the end of chemotherapy within the 6 months prior to inclusion date * Patients under any immune-suppressive medications, antibody therapy, corticosteroids, bone marrow transplant under the last 6 months of inclusion * Unsigned consent form

Design outcomes

Primary

MeasureTime frameDescription
To create an immune profile for each COVID19-positive patient during their ICU stay8 to 12 monthsA descriptive analysis of the innate and adaptive immune cells (phenotypically and functionally), along with circulating pro- and anti-inflammatory cytokines, and the dynamic change of immune cells and cytokines throughout the first 4 weeks of the COVID-19 infection.
To correlate patients' immune profile to disease severity and patient's outcome4 to 6 monthsA correlative analysis of the immune cells and cytokines levels with the COVID-19 severity and with the patient's outcome following their stay at the ICU. An attempt to identify markers associated with the disease severity and predictive measures to the patient's outcome.

Countries

Qatar

Contacts

Primary ContactDr. Ali Ait Hssain
a_aithssain@hotmail.com77172526

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026