- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04471051
An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Children's Hospital Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado Hospital
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Colorado Springs, Colorado, Forente stater, 80920
- UCHealth Memorial Hospital North
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Denver, Colorado, Forente stater, 80204
- Denver Health Medical Center
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Fort Collins, Colorado, Forente stater, 80524
- UCHealth Poudre Valley Hospital
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Highlands Ranch, Colorado, Forente stater, 80129
- UCHealth Highlands Ranch Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Inpatient Mortality
Tidsramme: Hospital admission up to Day 28 or discharge
|
Overall Inpatient Mortality
|
Hospital admission up to Day 28 or discharge
|
Requirement for mechanical ventilation
Tidsramme: Hospital admission up to Day 28 or discharge
|
Number of patients requiring mechanical ventilation
|
Hospital admission up to Day 28 or discharge
|
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
|
ICU Mortality
Tidsramme: Hospital admission up to Day 28 or discharge
|
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
|
Hospital admission up to Day 28 or discharge
|
Hospital Mortality
Tidsramme: Hospital admission up to Day 28 or discharge
|
Hospital admission up to Day 28 or discharge
|
|
Hospital Length of Stay (LOS)
Tidsramme: Hospital admission up to Day 28 or discharge
|
LOS, measured in days
|
Hospital admission up to Day 28 or discharge
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: John D Beckham, MD, University of Colorado, Denver
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20-0986
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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. .
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