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Convalescent Plasma in the Treatment of COVID 19

Primary Purpose

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

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Convalescent Plasma

About this trial

This is an interventional treatment trial for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) focused on measuring SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Trinity Health Of New England

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COVID-19 patients treated with convalescent plasma

Arm Description

Severely ill COVID-19 patients treated with convalescent plasma

Outcomes

Primary Outcome Measures

Mortality

Mortality within 28 days

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).

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04343261

First Posted

April 8, 2020

Last Updated

September 22, 2020

Sponsor

Trinity Health Of New England

1. Study Identification

Unique Protocol Identification Number

NCT04343261

Brief Title

Convalescent Plasma in the Treatment of COVID 19

Official Title

Convalescent Plasma in the Treatment of COVID 19

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

April 10, 2020 (Actual)

Primary Completion Date

July 23, 2020 (Actual)

Study Completion Date

August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Trinity Health Of New England

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

COVID-19 patients treated with convalescent plasma

Arm Type

Experimental

Arm Description

Severely ill COVID-19 patients treated with convalescent plasma

Intervention Type

Biological

Intervention Name(s)

Convalescent Plasma

Intervention Description

treatment with 2 Units of convalescent plasma

Primary Outcome Measure Information:

Title

Mortality

Description

Mortality within 28 days

Time Frame

Up to 28 days

Title

Viral Load

Description

Time Frame

Day 0, Day 3, Day 5, and Day 7

Title

Serum Antibody Titers

Description

Time Frame

Day 0, Day 3, Day 5, and Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Latha Dulipsingh, MD

Organizational Affiliation

Saint Francis Hospital and Medical Centerr/Trinity Health Of New England

Official's Role

Principal Investigator

Facility Information:

Facility Name

Trinity Health Of New England

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06105

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32883593

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.

Results Reference

result

PubMed Identifier

32951151

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.

Results Reference

result

PubMed Identifier

34013969

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.

Results Reference

derived

PubMed Identifier

33044747

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.

Results Reference

derived

Learn more about this trial

Convalescent Plasma in the Treatment of COVID 19

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