Convalescent Plasma for Treatment of COVID-19 Patients With Pneumonia

Sponsor
University of Virginia (Other)
Overall Status
Completed
CT.gov ID
NCT04374565
Collaborator
(none)
29
Enrollment
2
Locations
1
Arm
10
Actual Duration (Months)
14.5
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma
Phase 2

Detailed Description

There are no proven treatments for coronavirus disease (COVID-19) and associated pneumonia caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Recent experience in China suggests that convalescent immune plasma(CIP)may be an effective treatment for COVID-19. In the pandemic situation where there are no vaccines for COVID-19, specific antibodies in convalescent plasma induced by infection may provide passive protective immunity. Passive antibody therapy was the first immunotherapy dating back to the 1890's for the treatment of infectious diseases before the development of antibiotics 1940's. Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1 shows that such convalescent plasma contains neutralizing antibodies to the relevant virus. In SARS-CoV-2, passive antibody therapy from CIP probably provided protection by viral neutralization. CIP was also used in the 2013 Ebola epidemic. A small non-randomized study in Sierra Leone revealed a significant increase in survival for who received CIP4. CIP administration is the only approach that provides immediate immunity to patients who have been exposed or who have active disease.

This approach is immediately available from individuals who have recovered, are viral free,and can donate immune plasma (IP) containing high titer neutralizing antibodies. Passive antibody therapy can be given to a patient recently exposed or a patient who is developing an infection with COVID-19 by obtaining plasma units from immune individuals by standard plasmapheresis using FDA-approved blood banking procedures, cross matching the unit(s) to the recipients and infusing the unit(s) using standard transfusion procedures for blood products. Based on the safety and long-term experience with plasma infusions, plasma exchanges, and other procedures involving plasma or plasma product, this protocol was designed as a phase II single arm trial that involves the administration of antibodies to a given agent to a susceptible individual for the purpose of preventing or treating an infectious disease due to that agent.

The only antibody formulation that is available for emergent use is that found in convalescent plasma. As more individuals contract COVID-19 and recover, the number of potential donors will increase.

The principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease. When used for therapy, antibody is most effective when administered shortly after the onset of symptoms. The reason for temporal variation in efficacy is not well understood but could reflect that passive antibody works by neutralizing the initial inoculum, which is likely to be much smaller than that of established disease. Alternatively, antibodies may dampen the early inflammatory response leaving the infected individual asymptomatic. For example, antibody therapy for pneumococcal pneumonia was most effective when given shortly after the onset of symptoms and was of no benefit if antibody therapy was delayed beyond the third day of disease. For passive antibody therapy to be effective, a sufficient amount of antibody must be infused. The antibody will circulate in the blood, reach tissues,and provide protection against infection. Depending on the type of antibody, amount, and composition, the half-life can vary from weeks to months. It is under these circumstances, the investigators plan to treat patients who are sick enough to be hospitalized before the onset of overwhelming disease involving a systemic inflammatory response, sepsis, and/or ARDS.

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a single arm phase II trial to assess preliminary efficacy and confirm safety of infusions of antiSARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia by CXR or chest CT. A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.This is a single arm phase II trial to assess preliminary efficacy and confirm safety of infusions of antiSARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia by CXR or chest CT. A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of High-Titer Anti-SARS-CoV-2 (COVID19) Convalescent Plasma for Hospitalized Patients With Infection Due to COVID-19 to Decrease Complications: A Phase II Trial
Actual Study Start Date :
May 5, 2020
Actual Primary Completion Date :
Mar 5, 2021
Actual Study Completion Date :
Mar 5, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Study participants

A total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review.

Drug: High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma
Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants Transferred to Intensive Care Unit (ICU) [Days 0 - 60]

    Will be done by comparing the admission rate to the ICU between patients who received convalescent plasma and a control group who did not enroll in the study, or receive another experimental therapy.

  2. 28 Day Mortality [Days 0 - 28]

    Will be done by comparing the 28 day mortality rate between enrolled subjects and the control group.

Secondary Outcome Measures

  1. Number of Participants With Serious Adverse Events [Days 0 - 60]

    Will be collected from time of enrollment until completion of the study. The adverse events will be evaluated by CTCAE V5.0 and MedDRA.

  2. Duration of SARS-CoV-2 Positivity [Days 0 - 21]

    Respiratory tract swabs will be collected on days, 0, 7, 14, and 21 and will be tested for SARS-CoV-2. The outcome measurement is determining the duration from date of infection until date of first documented negative PCR test, which was assed up to 21 days

  3. Serum of Plasma Antibody Titer to SARS-CoV-2 [Day 28]

    Serum or plasma will be collected and analyzed for SARS-CoV-2 antibody.

  4. Cellular and Humoral Immune Response [Day 28]

    Blood will be collected and analyzed for for Spike IgG levels.

  5. Supplemental Oxygen Free Days [Days 0-28]

    All days where a supplemental oxygen is needed will be recorded as a concomitant medication and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the supplemental oxygen free days.

  6. Ventilator Free Days [Days 0 - 28]

    All days where a ventilator is needed will be recorded as a concomitant procedure and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ventilator free days.

  7. ICU Free Days [Days 0 - 28]

    All days where the participant is admitted to the ICU will be recorded and subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ICU free days.

  8. Sequential Organ Failure Assessment Score Improvement [days 0-28]

    Throughout the study, participants were evaluated by study physician using the sequential organ failure assessment score. This outcome measurement is looking for the number of participants who's score improved over the duration of the study.

  9. Number of Participants Who Needed for Vasopressors [Days 0 - 60]

    Concomitant medications will be recorded throughout the patients participation in the study and vasopressors will be recorded, if they are needed.

  10. Number of Participants Who Needed Renal Replacement Therapy [Days 0 - 60]

    Renal function will be assessed throughout the patients participation in the study. If renal replacement therapy is needed, it will be captured as a concomitant procedure.

  11. Number of Participants Who Needed Extracorporeal Membrane Oxygenation (ECMO) [Days 0 - 60]

    Respiratory function will be assessed throughout the patients participation in the study. If ECMO is needed, it will be captured as a concomitant procedure.

  12. Hospital Length of Stay (LOS) [Days 0-60]

    Will be calculated from the date the patient entered the hospital until they were discharged.

  13. ICU LOS [days 0 - 60]

    Will be calculated from the date the patient entered the ICU until they were discharged from the ICU.

  14. Number of Participants Who Had a Grade 3 or 4 Adverse Events (AEs) [Adverse events were collected from day 0 to 7 days post infusion.]

    All adverse events will be recorded and evaluated by CTCAE v.5.0. All grade 3 and 4 AEs will be calculated to determine safety of convalescent plasma.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients must be 18 years of age or older

  • Patients hospitalized with COVID-19 respiratory symptoms within 72 hours of admission to a"floor" bed (non-ICU bed) and confirmation via SARS-CoV-2 RT-PCR testing.

  • Patient and/or surrogate is willing and able to provide written informed consent and comply with all protocol requirements.

  • Patients with hematologic malignancies or solid tumors are eligible.

  • Patients with autoimmune disorders are eligible.

  • Patients with immunodeficiency and organ or stem cell transplant recipients are eligible.

  • Patients who have received or are receiving hydroxychloroquine or chloroquine are eligible (but will be taken off the drug)

  • Prior use of IVIG is allowed but the investigator should consider the potential for a hypercoagulable state.

Exclusion Criteria:
  • Patients requiring mechanical ventilation or >6 liters per minute nasal cannula oxygen

  • Patients on other anti-COVID-19 trials being treated with tocilizumab (anti-IL-6 receptor), Siltuximab (anti-IL-2), Remdesivir, or other pharmacological trials that may be initiated hereafter.

  • A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy).

  • Contraindication to transfusion or history of prior reactions to transfusion blood products.

  • Medical conditions for which receipt of 500-600 mL of intravenous fluid may be dangerous to the subject (e.g., decompensated congestive heart failure).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of Virginia Medical CenterCharlottesvilleVirginiaUnited States22903
2University of VirginiaCharlottesvilleVirginiaUnited States22903

Sponsors and Collaborators

  • University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Jeffrey Sturek, MD, PhD, Assistant Professor of Pulmonary and Critical Care Medicine, University of Virginia
ClinicalTrials.gov Identifier:
NCT04374565
Other Study ID Numbers:
  • 200114
First Posted:
May 5, 2020
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Period Title: Overall Study
STARTED29
COMPLETED29
NOT COMPLETED0

Baseline Characteristics

Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Overall Participants29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
57.6
(2.5)
Sex: Female, Male (Count of Participants)
Female
14
48.3%
Male
15
51.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
12
41.4%
Not Hispanic or Latino
17
58.6%
Unknown or Not Reported
0
0%

Outcome Measures

1. Primary Outcome
TitleNumber of Participants Transferred to Intensive Care Unit (ICU)
DescriptionWill be done by comparing the admission rate to the ICU between patients who received convalescent plasma and a control group who did not enroll in the study, or receive another experimental therapy.
Time FrameDays 0 - 60

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Count of Participants [Participants]
4
13.8%
2. Primary Outcome
Title28 Day Mortality
DescriptionWill be done by comparing the 28 day mortality rate between enrolled subjects and the control group.
Time FrameDays 0 - 28

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Count of Participants [Participants]
2
6.9%
3. Secondary Outcome
TitleNumber of Participants With Serious Adverse Events
DescriptionWill be collected from time of enrollment until completion of the study. The adverse events will be evaluated by CTCAE V5.0 and MedDRA.
Time FrameDays 0 - 60

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Count of Participants [Participants]
4
13.8%
4. Secondary Outcome
TitleDuration of SARS-CoV-2 Positivity
DescriptionRespiratory tract swabs will be collected on days, 0, 7, 14, and 21 and will be tested for SARS-CoV-2. The outcome measurement is determining the duration from date of infection until date of first documented negative PCR test, which was assed up to 21 days
Time FrameDays 0 - 21

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Mean (Standard Error) [days]
20.4
(1.57)
5. Secondary Outcome
TitleSerum of Plasma Antibody Titer to SARS-CoV-2
DescriptionSerum or plasma will be collected and analyzed for SARS-CoV-2 antibody.
Time FrameDay 28

Outcome Measure Data

Analysis Population Description
Median IgG anti-spoke protein (ug/ml)
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Median (Full Range) [ug/mL]
7.7
6. Secondary Outcome
TitleCellular and Humoral Immune Response
DescriptionBlood will be collected and analyzed for for Spike IgG levels.
Time FrameDay 28

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Median (Inter-Quartile Range) [ug/mL]
58.0
7. Secondary Outcome
TitleSupplemental Oxygen Free Days
DescriptionAll days where a supplemental oxygen is needed will be recorded as a concomitant medication and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the supplemental oxygen free days.
Time FrameDays 0-28

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Mean (Inter-Quartile Range) [Days]
23.5
8. Secondary Outcome
TitleVentilator Free Days
DescriptionAll days where a ventilator is needed will be recorded as a concomitant procedure and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ventilator free days.
Time FrameDays 0 - 28

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Mean (Standard Error) [days]
24.93
(1.46)
9. Secondary Outcome
TitleICU Free Days
DescriptionAll days where the participant is admitted to the ICU will be recorded and subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ICU free days.
Time FrameDays 0 - 28

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Mean (Standard Error) [days]
24.59
(1.61)
10. Secondary Outcome
TitleSequential Organ Failure Assessment Score Improvement
DescriptionThroughout the study, participants were evaluated by study physician using the sequential organ failure assessment score. This outcome measurement is looking for the number of participants who's score improved over the duration of the study.
Time Framedays 0-28

Outcome Measure Data

Analysis Population Description
Number of participants whose score improved throughout their admission.
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Count of Participants [Participants]
27
93.1%
11. Secondary Outcome
TitleNumber of Participants Who Needed for Vasopressors
DescriptionConcomitant medications will be recorded throughout the patients participation in the study and vasopressors will be recorded, if they are needed.
Time FrameDays 0 - 60

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Count of Participants [Participants]
4
13.8%
12. Secondary Outcome
TitleNumber of Participants Who Needed Renal Replacement Therapy
DescriptionRenal function will be assessed throughout the patients participation in the study. If renal replacement therapy is needed, it will be captured as a concomitant procedure.
Time FrameDays 0 - 60

Outcome Measure Data

Analysis Population Description
number of study patients who required renal therapy
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Count of Participants [Participants]
1
3.4%
13. Secondary Outcome
TitleNumber of Participants Who Needed Extracorporeal Membrane Oxygenation (ECMO)
DescriptionRespiratory function will be assessed throughout the patients participation in the study. If ECMO is needed, it will be captured as a concomitant procedure.
Time FrameDays 0 - 60

Outcome Measure Data

Analysis Population Description
number of patients who received ECMO
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Count of Participants [Participants]
1
3.4%
14. Secondary Outcome
TitleHospital Length of Stay (LOS)
DescriptionWill be calculated from the date the patient entered the hospital until they were discharged.
Time FrameDays 0-60

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Mean (Standard Error) [days]
9.39
(1.56)
15. Secondary Outcome
TitleICU LOS
DescriptionWill be calculated from the date the patient entered the ICU until they were discharged from the ICU.
Time Framedays 0 - 60

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Mean (Standard Error) [days]
2.93
(1.72)
16. Secondary Outcome
TitleNumber of Participants Who Had a Grade 3 or 4 Adverse Events (AEs)
DescriptionAll adverse events will be recorded and evaluated by CTCAE v.5.0. All grade 3 and 4 AEs will be calculated to determine safety of convalescent plasma.
Time FrameAdverse events were collected from day 0 to 7 days post infusion.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
Measure Participants29
Count of Participants [Participants]
6
20.7%

Adverse Events

Time FrameAdverse events were collected from day 0 to 7 days post infusion.
Adverse Event Reporting Description
Arm/Group TitleStudy Participants
Arm/Group DescriptionA total of 29 eligible subjects will be enrolled to receive high titer anti-SARS-CoV-2 plasma. Participants will be compared to a historical control group via retrospective chart review. High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma: Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
All Cause Mortality
Study Participants
Affected / at Risk (%)# Events
Total2/29 (6.9%)
Serious Adverse Events
Study Participants
Affected / at Risk (%)# Events
Total4/29 (13.8%)
Blood and lymphatic system disorders
Sepsis1/29 (3.4%) 2
Respiratory, thoracic and mediastinal disorders
Respiratory Failure3/29 (10.3%) 3
Other (Not Including Serious) Adverse Events
Study Participants
Affected / at Risk (%)# Events
Total11/29 (37.9%)
Cardiac disorders
Hypertension urgency1/29 (3.4%) 1
hypotension1/29 (3.4%) 1
atrial fibrillation1/29 (3.4%) 1
General disorders
epistaxis1/29 (3.4%) 1
Hepatobiliary disorders
creatine increased1/29 (3.4%) 1
ALT/AST increased1/29 (3.4%) 1
Infections and infestations
fever3/29 (10.3%) 3
Respiratory, thoracic and mediastinal disorders
Hypoxia1/29 (3.4%) 1
Pulmonary Edema5/29 (17.2%) 6
Vascular disorders
syncope1/29 (3.4%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleDr. Jeffrey Sturek
OrganizationUniversity of Virginia
Phone434-284-1776
EmailJMS3HK@hscmail.mcc.virginia.edu
Responsible Party:
Jeffrey Sturek, MD, PhD, Assistant Professor of Pulmonary and Critical Care Medicine, University of Virginia
ClinicalTrials.gov Identifier:
NCT04374565
Other Study ID Numbers:
  • 200114
First Posted:
May 5, 2020
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022