NCT04472572

Brief Summary

This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

First QC Date

July 14, 2020

Last Update Submit

October 7, 2022

Conditions

COVID-19

Keywords

CoronavirusCovid19SARS-CoV-2

Interventions

Convalescent PlasmaBIOLOGICAL

Fresh or frozen plasma will be infused one time to patients with COVID-19 infection

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at least 18 years
  • Laboratory confirmed diagnosis of infection with SARS-CoV-2
  • Admitted to the hospital for the treatment of COVID-19 complications
  • Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
  • Informed consent provided by the patient or healthcare proxy
  • Severe COVID-19 is defined by one or more of the following:
  • dyspnea
  • respiratory frequency ≥ 30/min
  • blood oxygen saturation ≤ 93%
  • partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
  • lung infiltrates \> 50% within 24 to 48 hours
  • Life-threatening COVID-19 is defined as one or more of the following:
  • respiratory failure/mechanical ventilation
  • septic shock
  • multiple organ dysfunction or failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (5)

  • Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA. 2020 Apr 28;323(16):1561-1562. doi: 10.1001/jama.2020.4940. No abstract available.

    PMID: 32219429BACKGROUND

  • Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.

    PMID: 32219428BACKGROUND

  • Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.

    PMID: 25030060BACKGROUND

  • Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Muller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.

    PMID: 29923831BACKGROUND

  • https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds

    BACKGROUND

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Michele Donato

    Hackensack Meridian Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 15, 2020

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations

US(1)