- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04471051
An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This a prospective, observational cohort trial to evaluate safety, clinical outcomes, and SARS-CoV2 antibody responses in patients who were treated with anti-SARS-CoV-2 convalescent plasma under Expanded Access protocol, NCT04372368. Hospitalized patients with acute respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia will be enrolled. The investigators anticipate that a minimum of 150 eligible subjects will be enrolled to receive COVID19 convalescent plasma over the 12 month period for the FDA IND expanded access protocol, NCT04372368, to provide COVID19 convalescent serum, which is a separate treatment trial. This observational protocol will co-enroll patients in parallel with the expanded access protocol and expects to enroll approximately the same number of patients but no treatment will be provided as part of this protocol. Additionally, the investigators will use Compass data with identifiers to pull information on hospitalized control COVID19+ patients from hospital admission date 4/20 to current for comparison.
This protocol is limited to data collection using the EMR to evaluate outcomes following COVID19 convalescent plasma treatment. Patient-linked specimens will not be obtained and analyzed outside of the expanded access protocol for distribution of COVID19 convalescent plasma. For this protocol, only de-identified, discarded samples may be obtained during routine patient care. Thus, consent will only be obtained from patients/subjects for participation in data abstraction/analysis from the electronic medical record.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Children's Hospital Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Hospital
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Colorado Springs, Colorado, Forenede Stater, 80920
- UCHealth Memorial Hospital North
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Denver, Colorado, Forenede Stater, 80204
- Denver Health Medical Center
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Fort Collins, Colorado, Forenede Stater, 80524
- UCHealth Poudre Valley Hospital
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Highlands Ranch, Colorado, Forenede Stater, 80129
- UCHealth Highlands Ranch Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age 18 years or older
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
- Patient treated with COVID19 convalescent plasma.
- Patient or surrogate designated decision maker is willing and able to provide written informed consent.
Exclusion Criteria:
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood products
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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COVID19 Convalescent Plasma Treatment
Hospitalized COVID19 patients who receive COVID19 Convalescent Plasma under Expanded Access protocol NCT04372368.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Inpatient Mortality
Tidsramme: Hospital admission up to Day 28 or discharge
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Overall Inpatient Mortality
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Hospital admission up to Day 28 or discharge
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Requirement for mechanical ventilation
Tidsramme: Hospital admission up to Day 28 or discharge
|
Number of patients requiring mechanical ventilation
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Hospital admission up to Day 28 or discharge
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Transfer to ICU
Tidsramme: Hospital admission up to Day 28 or discharge
|
Number of patients transferred to an Intensive Care Unit (ICU)
|
Hospital admission up to Day 28 or discharge
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ICU Mortality
Tidsramme: Hospital admission up to Day 28 or discharge
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Hospital admission up to Day 28 or discharge
|
|
ICU Length of Stay (LOS)
Tidsramme: Hospital admission up to Day 28 or discharge
|
LOS, measured in days
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Hospital admission up to Day 28 or discharge
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Hospital Mortality
Tidsramme: Hospital admission up to Day 28 or discharge
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Hospital admission up to Day 28 or discharge
|
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Hospital Length of Stay (LOS)
Tidsramme: Hospital admission up to Day 28 or discharge
|
LOS, measured in days
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Hospital admission up to Day 28 or discharge
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: John D Beckham, MD, University of Colorado, Denver
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20-0986
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Covid19
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Henry Ford Health SystemAfsluttet
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Ricardo Pereira MestreInstitute of Oncology Research (IOR); Istituto Cantonale di PatologiaAfsluttet
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Instituto de Investigación Hospital Universitario...Instituto de Salud Carlos III; Spanish Clinical Research Network - SCReNAktiv, ikke rekrutterende
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Inmunova S.A.Hospital Italiano de Buenos Aires; Laboratorio Elea Phoenix S.A.; Hospital... og andre samarbejdspartnereAfsluttet
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Manchester University NHS Foundation TrustUniversity of ManchesterAfsluttet
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Rush University Medical CenterHospital Civil de GuadalajaraAfsluttetCovid19Forenede Stater, Mexico
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Evelyne D.TrottierAfsluttet
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Sinovac Research and Development Co., Ltd.Afsluttet
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Mabwell (Shanghai) Bioscience Co., Ltd.Shanghai Public Health Clinical CenterAfsluttet
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Anavasi DiagnosticsIkke rekrutterer endnu