Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System
8. april 2022 oppdatert av: Prof Evangelos Terpos, National and Kapodistrian University of Athens
Study of the Kinetics of Antibodies Against SARS-CoV-2 and of Cellular Subpopulations of the Immune System in Volunteers Receiving the BNT162b2 Vaccine or Other Approved Vaccine Against SARS-CoV-2
Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
The purpose of this study is to assess the kinetics of antibodies against SARS-CoV-2 as well as the kinetics of the immune system's cell subpopulations and cytokines associated with the immune system in healthy volunteers receiving the BNT162b2 vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies or any other vaccine authorized and administered by the Ministry of Health.
Immunoassays will be performed at serum collection points before and after vaccination, as set out in this study.
Studietype
Observasjonsmessig
Registrering (Forventet)
600
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ioanna Charitaki
- Telefonnummer: +30 6976156403
- E-post: j.charitaki@gmail.com
Studiesteder
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-
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Athens, Hellas
- Rekruttering
- Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
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Ta kontakt med:
- Evangelos Terpos, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The admission criteria include both healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine.
In particular, the study includes people with hematological malignancies or solid tumors, either receiving treatment or in remission/ follow-up, pursuant to the vaccination instructions of the Ministry of Health.
The study will also include patients with autoimmune diseases who receive or do not receive treatment for their disease.
Patients with diabetes mellitus, hypertension, heart disease, chronic renal failure of all stages (and undergoing dialysis) or other chronic diseases deemed suitable for vaccination, according to the instructions of the Ministry of Health, may also participate in the study.
Beskrivelse
Inclusion Criteria:
- Healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine
- Age ≥ 18 years old
Exclusion Criteria:
- Serious allergy problems i.e. hospitalization due to a serious allergic reaction (anaphylaxis)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Cohort 1
Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
|
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
|
|
Cohort 2
People with hematological malignancies or solid tumors in various phases of their treatment (under treatment or in remission/ follow-up).
This cohort may include patients with smoldering multiple myeloma (n=50), multiple myeloma (n=140), chronic lymphocytic leukemia (with or without hypoglobulinemia) (n=50), lymphoma (n=80), AL amyloidosis (n=30), patients who receive PARP (n=30), CDK4/6 (n=30), or immune checkpoint inhibitors (n=40), and patients under therapy with Androgen Receptor Targeted Agents (n=50).
|
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Neutralizing antibodies against SARS-CoV-2
Tidsramme: Day 50 (28 days after the second dose of the vaccine)
|
Primary endpoint of the study is the development of neutralizing antibodies against SARS-CoV-2 on Day 50 28 days after the second dose of the vaccine) in the study populations
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Day 50 (28 days after the second dose of the vaccine)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
Tidsramme: Day 1
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Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
|
Day 1
|
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Neutralizing antibodies against SARS-CoV-2
Tidsramme: Day 8
|
Development of neutralizing antibodies against SARS-CoV-2 on day 8
|
Day 8
|
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Neutralizing antibodies against SARS-CoV-2
Tidsramme: Day 22
|
Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Neutralizing antibodies against SARS-CoV-2
Tidsramme: Day 36
|
Development of neutralizing antibodies against SARS-CoV-2 on day 36
|
Day 36
|
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Neutralizing antibodies against SARS-CoV-2
Tidsramme: Month 3
|
Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
|
Month 3
|
|
Neutralizing antibodies against SARS-CoV-2
Tidsramme: Month 6
|
Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
|
Month 6
|
|
Neutralizing antibodies against SARS-CoV-2
Tidsramme: Month 9
|
Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
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Month 9
|
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Neutralizing antibodies against SARS-CoV-2
Tidsramme: Month 12
|
Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
|
Month 12
|
|
Neutralizing antibodies against SARS-CoV-2
Tidsramme: Month 18
|
Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
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Month 18
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsramme: Day 1
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
|
Day 1
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsramme: Day 8
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8
|
Day 8
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsramme: Day 22
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
|
Day 22
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsramme: Day 36
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36
|
Day 36
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsramme: Day 50
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50
|
Day 50
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsramme: Month 3
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
|
Month 3
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsramme: Month 6
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
|
Month 6
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsramme: Month 9
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
|
Month 9
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsramme: Month 12
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
|
Month 12
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsramme: Month 18
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
|
Month 18
|
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Number of memory B-cells against SARS-CoV-2
Tidsramme: Day 1
|
According to antibody responses on day 1
|
Day 1
|
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Number of memory B-cells against SARS-CoV-2
Tidsramme: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of memory B-cells against SARS-CoV-2
Tidsramme: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
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Number of memory B-cells against SARS-CoV-2
Tidsramme: Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of memory B-cells against SARS-CoV-2
Tidsramme: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of memory B-cells against SARS-CoV-2
Tidsramme: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
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Number of memory B-cells against SARS-CoV-2
Tidsramme: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
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Number of memory B-cells against SARS-CoV-2
Tidsramme: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of memory B-cells against SARS-CoV-2
Tidsramme: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
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Number of memory B-cells against SARS-CoV-2
Tidsramme: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
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Number of memory T-cells against SARS-CoV-2
Tidsramme: Day 1
|
According to antibody responses on day 1
|
Day 1
|
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Number of memory T-cells against SARS-CoV-2
Tidsramme: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of memory T-cells against SARS-CoV-2
Tidsramme: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of memory T-cells against SARS-CoV-2
Tidsramme: Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of memory T-cells against SARS-CoV-2
Tidsramme: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of memory T-cells against SARS-CoV-2
Tidsramme: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
|
Number of memory T-cells against SARS-CoV-2
Tidsramme: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
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Number of memory T-cells against SARS-CoV-2
Tidsramme: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of memory T-cells against SARS-CoV-2
Tidsramme: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
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Number of memory T-cells against SARS-CoV-2
Tidsramme: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
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Number of monocytes (CD14+, CD16+)
Tidsramme: Day 1
|
According to antibody responses on day 1
|
Day 1
|
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Number of monocytes (CD14+, CD16+)
Tidsramme: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of monocytes (CD14+, CD16+)
Tidsramme: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of monocytes (CD14+, CD16+)
Tidsramme: Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of monocytes (CD14+, CD16+)
Tidsramme: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of monocytes (CD14+, CD16+)
Tidsramme: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
|
Number of monocytes (CD14+, CD16+)
Tidsramme: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
|
Number of monocytes (CD14+, CD16+)
Tidsramme: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of monocytes (CD14+, CD16+)
Tidsramme: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of monocytes (CD14+, CD16+)
Tidsramme: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsramme: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsramme: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsramme: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsramme: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsramme: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsramme: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsramme: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsramme: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsramme: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsramme: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsramme: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
TNF-a levels
Tidsramme: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
TNF-a levels
Tidsramme: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
TNF-a levels
Tidsramme: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
TNF-a levels
Tidsramme: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
TNF-a levels
Tidsramme: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
TNF-a levels
Tidsramme: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
TNF-a levels
Tidsramme: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
TNF-a levels
Tidsramme: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
TNF-a levels
Tidsramme: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
TNF-a levels
Tidsramme: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
TNF-a levels
Tidsramme: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
CRP levels
Tidsramme: Day 1
|
CRP blood level measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
CRP levels
Tidsramme: Day 8
|
CRP blood level measurements on day 8
|
Day 8
|
|
CRP levels
Tidsramme: Day 22
|
CRP blood level measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
CRP levels
Tidsramme: Day 23
|
CRP blood level measurements on day 23
|
Day 23
|
|
CRP levels
Tidsramme: Day 36
|
CRP blood level measurements on day 36
|
Day 36
|
|
CRP levels
Tidsramme: Day 50
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CRP blood level measurements on day 50
|
Day 50
|
|
CRP levels
Tidsramme: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
CRP levels
Tidsramme: Month 6
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Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
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CRP levels
Tidsramme: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
CRP levels
Tidsramme: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
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CRP levels
Tidsramme: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Evangelos Terpos, National and Kapodistrian University of Athens
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Dagla I, Iliou A, Benaki D, Gikas E, Mikros E, Bagratuni T, Kastritis E, Dimopoulos MA, Terpos E, Tsarbopoulos A. Plasma Metabolomic Alterations Induced by COVID-19 Vaccination Reveal Putative Biomarkers Reflecting the Immune Response. Cells. 2022 Apr 6;11(7):1241. doi: 10.3390/cells11071241.
- Gavriatopoulou M, Terpos E, Ntanasis-Stathopoulos I, Briasoulis A, Gumeni S, Malandrakis P, Fotiou D, Migkou M, Theodorakakou F, Eleutherakis-Papaiakovou E, Kanellias N, Kastritis E, Trougakos IP, Dimopoulos MA. Poor neutralizing antibody responses in 106 patients with WM after vaccination against SARS-CoV-2: a prospective study. Blood Adv. 2021 Nov 9;5(21):4398-4405. doi: 10.1182/bloodadvances.2021005444.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. januar 2021
Primær fullføring (Forventet)
1. august 2022
Studiet fullført (Forventet)
1. desember 2022
Datoer for studieregistrering
Først innsendt
3. februar 2021
Først innsendt som oppfylte QC-kriteriene
5. februar 2021
Først lagt ut (Faktiske)
8. februar 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Coronavirus-infeksjoner
- Coronaviridae-infeksjoner
- Nidovirales infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Neoplasmer
- Lungebetennelse, viral
- Lungebetennelse
- Lungesykdommer
- Neoplasmer etter nettsted
- Sykdomsattributter
- Hematologiske sykdommer
- Covid-19
- Hematologiske neoplasmer
- Kronisk sykdom
Andre studie-ID-numre
- 900/24-12-2020
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
At the end of the study, the results will be announced in medical conferences or medical journals.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .