Convalescent Plasma in the Treatment of COVID 19

COVID Clinical Trial

Official title:

Convalescent Plasma in the Treatment of COVID 19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343261
• Other study ID #: SFH-20-23
• Status: Completed
• Phase: Phase 2
• Start date: April 10, 2020
• Est. completion date: August 13, 2020

Study information

• Verified date: September 2020
• Source: Saint Francis Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 13, 2020
• Est. primary completion date: July 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Intervention

Biological:
• Convalescent Plasma
treatment with 2 Units of convalescent plasma

Locations

Country	Name	City	State
United States	Trinity Health Of New England	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Saint Francis Care

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality within 28 days	Up to 28 days
Primary	Viral Load	Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry.; The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).	Day 0, Day 3, Day 5, and Day 7
Primary	Serum Antibody Titers	Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is > or = 1.0 arbitrary units/mL [AU/mL] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)	Day 0, Day 3, Day 5, and Day 7