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NCT04472572 Clinical Trial

Expanded Access to Convalescent Plasma for Treatment of COVID-19

COVID-19 Clinical Trial

Official title:
Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04472572
Other study ID # Pro2020-0663
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date October 2022
Source Hackensack Meridian Health
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age at least 18 years 2. Laboratory confirmed diagnosis of infection with SARS-CoV-2 3. Admitted to the hospital for the treatment of COVID-19 complications 4. 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 5. Informed consent provided by the patient or healthcare proxy 6. 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Convalescent Plasma
Fresh or frozen plasma will be infused one time to patients with COVID-19 infection

Locations
Country Name City State
United States Hackensack University Medical Center Hackensack New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Müller 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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