Clinical trial NCT04473131: Immune Profiling of COVID19-patients Admitted to ICU
Official title: Immune Profiling of COVID-19-infected Patients Admitted to the Intensive Care Unit (ICU): the IMPROVISE Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
ICU
Immune profiling
Humoral immunity
Cellular immunity
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Qatar University
name: Weill Cornell Medical College in Qatar
First posted: 2020-07-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, we are targeting to enroll two categories of patients from ICU: 100 COVID19-positive patients, and 100 COVID19-negative patients.

In addition to 100 healthy volunteers from the blood donation center.

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.


Eligibility criteria: 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

Primary outcomes:
measure: To create an immune profile for each COVID19-positive patient during their ICU stay
timeFrame: 8 to 12 months
measure: To correlate patients' immune profile to disease severity and patient's outcome
timeFrame: 4 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
References:
citation: Bradic M, Taleb S, Thomas B, Chidiac O, Robay A, Hassan N, Malek J, Ait Hssain A, Abi Khalil C. DNA methylation predicts the outcome of COVID-19 patients with acute respiratory distress syndrome. J Transl Med. 2022 Nov 12;20(1):526. doi: 10.1186/s12967-022-03737-5.