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Immune Profiling of COVID19-patients Admitted to ICU (IMPROVISE)

15. juli 2020 opdateret af: Ali Ait Hssain, Hamad Medical Corporation

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

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Qatar
      • Doha, Qatar
        • Rekruttering
        • Hamad Medical Corporation
        • Kontakt:
        • Ledende efterforsker:
          • Ali Ait Hssain
        • Underforsker:
          • Sara Taleb

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
COVID-19 positive

Inclusion criteria:

  1. Male or female aged over 18 years
  2. Admitted patients to ICU with a suspicious COVID19 infection
  3. Tested positive for SARS-CoV-2

Exclusion criteria:

  1. Burn and trauma
  2. Any immunological diseases, or immunosuppressive medications
  3. Other immune-related conditions (cancer, hematological malignancies, bone marrow diseases or transplant)

Sample collection time points: 4 to 5 (day 1-3, day 7, day 14, day 21, discharge day from ICU -between day 30-60- if possible)
Andet: No intervention
Only blood samples will be taken from participants for this study
COVID-19 negative

Inclusion criteria:

  1. Male or female aged over 18 years
  2. Admitted patients to ICU
  3. Tested negative for SARS-CoV-2

Exclusion criteria:

  1. Burn and trauma
  2. Any immunological diseases, or immunosuppressive medications
  3. Other immune-related conditions (cancer, hematological malignancies, bone marrow diseases or transplant)

Sample collection time points: 4 to 5 (day 1-3, day 7, day 14, day 21, discharge day from ICU -between day 30-60- if possible)
Andet: No intervention
Only blood samples will be taken from participants for this study
Heathy volunteers

Inclusion criteria:

  1. Male or female aged over 18 years
  2. Normal clinical examination

Exclusion criteria:

  1. Person with an infectious syndrome during the last 90 days
  2. Extreme physical stress within the last week
  3. Person receiving within the last 90 days, a treatment based on: antivirals; antibiotics; antiparasitics; antifungals; non-steroidal anti-inflammatory drugs; immunosuppressive therapy; corticosteroids; therapeutic antibodies; chemotherapy
  4. Person with history of: innate or acquired immune deficiency; hematological disease; solid tumor; severe chronic disease; surgery or hospitalization within the last 2 years; pregnancy within the last year; participation to a phase I clinical assay during the last year; participation to a phase I clinical assay during the last year; pregnant or breastfeeding women; a person with restricted liberty or under legal protection

Sample collection time points: 1 (day of blood sample donation)
Andet: No intervention
Only blood samples will be taken from participants for this study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To create an immune profile for each COVID19-positive patient during their ICU stay
Tidsramme: 8 to 12 months
A 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.
8 to 12 months
To correlate patients' immune profile to disease severity and patient's outcome
Tidsramme: 4 to 6 months
A 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.
4 to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hamad Medical Corporation

Samarbejdspartnere

Qatar University
Weill Cornell Medical College in Qatar

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. april 2020

Primær færdiggørelse (Forventet)

1. juni 2022

Studieafslutning (Forventet)

1. juni 2022

Datoer for studieregistrering

Først indsendt

15. juli 2020

Først indsendt, der opfyldte QC-kriterier

15. juli 2020

Først opslået (Faktiske)

16. juli 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MRC-05-007

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med COVID-19

Kliniske forsøg med No intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bulgaria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner