Clinical trial NCT04343261: Convalescent Plasma in the Treatment of COVID 19
Official title: Convalescent Plasma in the Treatment of COVID 19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
COVID
Coronavirus
Keywords: SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.

Detailed description: The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19.

1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19.

2. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.

Eligibility criteria: Inclusion Criteria:

* All genders
* Age \> 18 yrs and \< 90 yrs
* Must have laboratory confirmed COVID-19
* Must provide informed consent
* Must have severe or immediately life-threatening COVID-19,

Severe disease is defined as:

* 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 disease is defined as:

* respiratory failure,
* septic shock
* multiple organ dysfunction or failure

Exclusion Criteria:

* No gender exclusion
* Age \< 18 yrs and \> 90 yrs
* COVID-19 negative

Primary outcomes:
measure: Mortality
timeFrame: Up to 28 days
measure: Viral Load
timeFrame: Day 0, Day 3, Day 5, and Day 7
measure: Serum Antibody Titers
timeFrame: Day 0, Day 3, Day 5, and Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Trinity Health Of New England
state: Connecticut
Study officials:
affiliation: Saint Francis Hospital and Medical Centerr/Trinity Health Of New England
name: Latha Dulipsingh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dulipsingh L, Ibrahim D, Schaefer EJ, Crowell R, Diffenderfer MR, Williams K, Lima C, McKenzie J, Cook L, Puff J, Onoroski M, Wakefield DB, Eadie RJ, Kleiboeker SB, Nabors P, Hussain SA. SARS-CoV-2 serology and virology trends in donors and recipients of convalescent plasma. Transfus Apher Sci. 2020 Dec;59(6):102922. doi: 10.1016/j.transci.2020.102922. Epub 2020 Aug 25.
citation: Ibrahim D, Dulipsingh L, Zapatka L, Eadie R, Crowell R, Williams K, Wakefield DB, Cook L, Puff J, Hussain SA. Factors Associated with Good Patient Outcomes Following Convalescent Plasma in COVID-19: A Prospective Phase II Clinical Trial. Infect Dis Ther. 2020 Dec;9(4):913-926. doi: 10.1007/s40121-020-00341-2. Epub 2020 Sep 20.
citation: Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
citation: Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.