- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04472572
Expanded Access to Convalescent Plasma for Treatment of COVID-19
October 7, 2022 updated by: Hackensack Meridian Health
Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19
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.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Detailed Description
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.
Following enrollment on the protocol and provision of informed consent, patients will be transfused with approximately 200-500 mL of ABO compatible convalescent plasma obtained from individuals who have recovered from documented infection with SARS-CoV-2 and who have been found to have high anti-SARS-CoV2 titers.
Safety information collected will include serious adverse events judged to be related to the administration of convalescent plasma.
Other information to be collected retrospectively will include patient demographics, resource utilization (total length of stay, days in ICU, days intubated, and survival to discharge from the facility.
Study Type
Expanded Access
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michele Donato, Hackensack Meridian Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 14, 2020
First Submitted That Met QC Criteria
July 14, 2020
First Posted (Actual)
July 15, 2020
Study Record Updates
Last Update Posted (Actual)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 7, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2020-0663
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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