Clinical trial NCT04472572: Expanded Access to Convalescent Plasma for Treatment of COVID-19
Official title: Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: COVID-19
Keywords: Coronavirus
Covid19
SARS-CoV-2
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2020-07-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Michele Donato
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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.
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.
citation: 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.
citation: https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds