ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)

Sponsor
William Beaumont Hospitals (Other)
Overall Status
Terminated
CT.gov ID
NCT04432272
Collaborator
(none)
71
1
2
4.4
16

Study Details

Study Description

Brief Summary

The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90 (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Convalescent means it is taken from people who were infected with COVID-19 and recovered. The use of this blood product to treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not yet approved it to be sold commercially. This is a human blood product collected by licensed blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor criteria and must also meet all criteria set by the FDA for being a donor of COVID-19 convalescent plasma.

A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar studies are being done at other centers, but they are not directly related to this study.

Participants will be assigned to a study group depending on how sick they are.

  • Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on a ventilator

  • Group B: Those who require a ventilator to preserve their life.

Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood samples will be taken prior to and one hour after the transfusion to measure participant antibodies against Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) and a nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure antibody levels to determine if the plasma caused the antibody level to rise. Similarly, blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after the transfusion while the participant is in the hospital The participant's final health status will be determined on day 28. Hospital records will be monitored for 90 days after discharge to determine if the participant is readmitted to the hospital.

Condition or Disease Intervention/Treatment Phase
  • Biological: COVID-19 convalescent plasma
Phase 2

Detailed Description

This trial will evaluate the efficacy and safety of SARS-CoV-2 convalescent plasma as treatment for confirmed COVID-19 respiratory disease (as defined in the inclusion criteria). Participants in both group A and group B will receive COVID-19 convalescent plasma. Group A will include hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain O2 saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. Group B will include hospitalized COVID-19 patients ages ≥18 years requiring intubation. Patients may be enrolled in group A within 14 days of admission to the hospital and may be enrolled in group B at any time after intubation. A total of 300 eligible subjects with significant oxygen requirements and 200 eligible subjects who require intubation will be included in the study. They will receive convalescent plasma from either a patient who has recovered from COVID-19 or from an asymptomatic carrier with confirmed Immunoglobulin-G (IgG) antibodies against SARS-CoV-2. Subjects will not be randomized. The amount of anti-SARS-CoV-2 IgG and Immunoglobulin-A (IgA) antibodies in any unit of plasma will not be known when the unit is assigned to the patient. This will allow us to examine the relationship between the amount of anti-SARS-CoV-2 antibody and outcomes. Analysis will be based on measurement of optical density of the IgG level in the unit of plasma the patient is randomly supplied by the blood bank. While investigators and patients will be aware the patient is receiving a unit of COVID-19 convalescent plasma, both the investigators and the patients will be blinded to the antibody content of that unit.

COVID-19 convalescent plasma (1 unit; ~200mL) will be produced by a blood bank licensed to produce plasma using standard screening and safety procedures. The product may be procured from patients who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA.

Participants at the eight Michigan hospitals comprising the Beaumont Health system may be eligible to participate. Study oversight and coordination will occur centrally, from the Infectious Disease Research Department at Beaumont's Royal Oak campus.

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, single health system, non-randomized, open-label study.Prospective, single health system, non-randomized, open-label study.
Masking:
None (Open Label)
Masking Description:
No parties blinded as to receipt of study article. Participant, care provider and investigator blinded to actual antibody concentration in unit of plasma provided.
Primary Purpose:
Treatment
Official Title:
ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)
Actual Study Start Date :
Jul 16, 2020
Actual Primary Completion Date :
Nov 13, 2020
Actual Study Completion Date :
Nov 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days.

Biological: COVID-19 convalescent plasma
Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit

Experimental: Group B

Hospitalized COVID-19 patients ages ≥18 years requiring intubation.

Biological: COVID-19 convalescent plasma
Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit

Outcome Measures

Primary Outcome Measures

  1. Avoidance of Intubation at 28 Days (Group A) [28 days]

    Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and who are admitted <14 days) who remain un-intubated

  2. Mortality (Group B) [28 days]

    Count of group B participants (participants who are intubated at study entry) who die

Secondary Outcome Measures

  1. Cardio-circulatory Arrest [28 days]

    Count of participants who experienced cardio-circulatory arrest

  2. Patient Outcome at 28 Days [28 days]

    Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcome

  3. Renal Failure [28 days]

    Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.

  4. Liver Failure [28 days]

    Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of >25%

  5. Cytokine Storm [28 days]

    Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)

  6. Respiratory Support [28 days]

    Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather mask, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation. Patients may receive more than one type of support during their hospital stay.

  7. Vasopressor Medication Support [28 days]

    Count of participants who received pressor drugs, as ordered by treating physicians

  8. Length of ICU Length of Stay [28 days]

    Length of ICU stay in days, for participants who entered ICU

  9. Intensive Care Unit (ICU) Mortality [28 days]

    Count of patients admitted to the ICU who die in ICU

  10. Hospital Length of Stay [28 days]

    Length of hospital stay in days

  11. Ventilator Free Days [28 days]

    Number of ventilator-free hospitalized days

  12. Intubation Duration [28 days]

    Length of intubation, measured in days

  13. Readmission [90 days]

    Count of participants readmitted to hospital following index procedure hospital discharge

  14. Serum Anti-SARS-CoV-2 IgG [During hospitalization, a maximum of 28 days]

    Count of participants positive for serum anti-SARS-CoV-2 IgG as assayed by the EUROIMMUN Anti-SARS-CoV-2 assay, evaluated semi-quantitatively by calculation of a ratio of the extinction of the patient sample over the extinction of a calibrator. This ratio is interpreted as: ratio < 0.8 is negative, ratio ≥ 0.8 to <1.0 is considered borderline, and ratio ≥ 1.1 is positive.

  15. SARS-CoV-2 RNA [During hospitalization, a maximum of 28 days]

    Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.

  16. Mortality (Group A) [28 days]

    Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and admitted <14 days) who die

  17. Time From Transfusion to End of Ventilator Support (Group B) [During hospitalization, a maximum of 28 days]

    Number of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)

Eligibility Criteria

Criteria

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

  • Hospitalized with confirmed COVID-19 infection via COVID-19 SARS-CoV-2 Reverse-transcription polymerase chain reaction (RT-PCR) testing.

  • Symptoms consistent with COVID-19 infection (fever, acute onset cough, shortness of breath) at time of screening.

  • Patient requires >6 L nasal cannula oxygen (Group A) or intubated (Group B).

  • Patient (or their legal authorized representative) is willing and able to provide written informed consent and comply with all protocol requirements.

Exclusion Criteria:
  • For patients in Group A admitted for >14 days

  • Female subjects with positive pregnancy test, breastfeeding, or planning to become --pregnant or breastfeed during the study period.

  • Receipt of pooled immunoglobulin in past 30 days.

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

  • Patients currently undergoing cancer treatment or those who are presently immunocompromised.

  • Patient who in the opinion of the investigator will not be a good study candidate.

Contacts and Locations

Locations

Site City State Country Postal Code
1 William Beaumont Hospital Royal Oak Michigan United States 48073

Sponsors and Collaborators

  • William Beaumont Hospitals

Investigators

  • Principal Investigator: Matthew Sims, MD PhD, Beaumont Health

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Matthew Sims, MD, PhD, Director Infectious Disease Research, Beaumont Health; Professor of Internal Medicine and Foundational Medical Studies, OUWB School of Medicine, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT04432272
Other Study ID Numbers:
  • 2020-198
First Posted:
Jun 16, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Matthew Sims, MD, PhD, Director Infectious Disease Research, Beaumont Health; Professor of Internal Medicine and Foundational Medical Studies, OUWB School of Medicine, William Beaumont Hospitals
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Period Title: Overall Study
STARTED 43 28
COMPLETED 43 28
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Group A Group B Total
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Total of all reporting groups
Overall Participants 43 28 71
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
72.95
(10.37)
62.83
(13.53)
68.96
(12.65)
Sex: Female, Male (Count of Participants)
Female
13
30.2%
9
32.1%
22
31%
Male
30
69.8%
19
67.9%
49
69%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
2
4.7%
0
0%
2
2.8%
Not Hispanic or Latino
40
93%
26
92.9%
66
93%
Unknown or Not Reported
1
2.3%
2
7.1%
3
4.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
1
2.3%
3
10.7%
4
5.6%
White
41
95.3%
20
71.4%
61
85.9%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
1
2.3%
5
17.9%
6
8.5%
Region of Enrollment (participants) [Number]
United States
43
100%
28
100%
71
100%

Outcome Measures

1. Primary Outcome
Title Avoidance of Intubation at 28 Days (Group A)
Description Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and who are admitted <14 days) who remain un-intubated
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group A
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 43
Count of Participants [Participants]
26
60.5%
2. Primary Outcome
Title Mortality (Group B)
Description Count of group B participants (participants who are intubated at study entry) who die
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 28
Count of Participants [Participants]
17
39.5%
3. Secondary Outcome
Title Cardio-circulatory Arrest
Description Count of participants who experienced cardio-circulatory arrest
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 43 28
Count of Participants [Participants]
13
30.2%
13
46.4%
4. Secondary Outcome
Title Patient Outcome at 28 Days
Description Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcome
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 43 28
1= Not hospitalized, no limitations on activities
3
7%
0
0%
2 =Not hospitalized, limitation on activities
12
27.9%
4
14.3%
3= Hospitalized, not requiring supplemental oxygen
0
0%
0
0%
4 =Hospitalized, requiring supplemental oxygen
3
7%
1
3.6%
5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices
2
4.7%
1
3.6%
6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
2
4.7%
5
17.9%
7=Deceased
21
48.8%
17
60.7%
5. Secondary Outcome
Title Renal Failure
Description Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 43 28
Count of Participants [Participants]
2
4.7%
7
25%
6. Secondary Outcome
Title Liver Failure
Description Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of >25%
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 43 28
Count of Participants [Participants]
1
2.3%
1
3.6%
7. Secondary Outcome
Title Cytokine Storm
Description Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
Data not available for 10 Group A participants and 8 group B participants
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 33 20
Count of Participants [Participants]
9
20.9%
5
17.9%
8. Secondary Outcome
Title Respiratory Support
Description Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather mask, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation. Patients may receive more than one type of support during their hospital stay.
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 43 28
Ventilator
19
44.2%
27
96.4%
Coldflow
1
2.3%
0
0%
CPAP
11
25.6%
2
7.1%
BiPAP
25
58.1%
4
14.3%
Non-rebreather mask
19
44.2%
3
10.7%
Nasal cannula
27
62.8%
8
28.6%
High flow nasal cannula
37
86%
7
25%
9. Secondary Outcome
Title Vasopressor Medication Support
Description Count of participants who received pressor drugs, as ordered by treating physicians
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 43 28
Count of Participants [Participants]
19
44.2%
27
96.4%
10. Secondary Outcome
Title Length of ICU Length of Stay
Description Length of ICU stay in days, for participants who entered ICU
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
Analysis population is those participants in each group that entered the ICU
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 27 26
Mean (Standard Deviation) [days]
17.59
(10.16)
22.12
(10.37)
11. Secondary Outcome
Title Intensive Care Unit (ICU) Mortality
Description Count of patients admitted to the ICU who die in ICU
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
Data was not collected or analyzed for this outcome
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 0 0
12. Secondary Outcome
Title Hospital Length of Stay
Description Length of hospital stay in days
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
Data not available for 1 Group B participants
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 43 27
Mean (Standard Deviation) [days]
23.63
(9.83)
26.41
(11.12)
13. Secondary Outcome
Title Ventilator Free Days
Description Number of ventilator-free hospitalized days
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
Data available in Group A for 8 of 15 participants who were intubated, and in Group B for 7 of 15 participants who were intubated
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 8 7
Mean (Standard Deviation) [days]
9.13
(12.64)
14.23
(14.80)
14. Secondary Outcome
Title Intubation Duration
Description Length of intubation, measured in days
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 43 28
Mean (Standard Deviation) [days]
4.12
(6.23)
13.93
(9.45)
15. Secondary Outcome
Title Readmission
Description Count of participants readmitted to hospital following index procedure hospital discharge
Time Frame 90 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 43 28
Count of Participants [Participants]
6
14%
3
10.7%
16. Secondary Outcome
Title Serum Anti-SARS-CoV-2 IgG
Description Count of participants positive for serum anti-SARS-CoV-2 IgG as assayed by the EUROIMMUN Anti-SARS-CoV-2 assay, evaluated semi-quantitatively by calculation of a ratio of the extinction of the patient sample over the extinction of a calibrator. This ratio is interpreted as: ratio < 0.8 is negative, ratio ≥ 0.8 to <1.0 is considered borderline, and ratio ≥ 1.1 is positive.
Time Frame During hospitalization, a maximum of 28 days

Outcome Measure Data

Analysis Population Description
A change in the Emergency Use Authorization for plasma transfusion during COVID-19 occurred during the study. Untitered plasma was no longer available. Thus, data was not analyzed for this outcome.
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 0 0
17. Secondary Outcome
Title SARS-CoV-2 RNA
Description Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.
Time Frame During hospitalization, a maximum of 28 days

Outcome Measure Data

Analysis Population Description
Data not available for 4 out of the 43 Group A participants. Data not available for 3 out of the 28 Group B participants.
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 39 25
Count of Participants [Participants]
36
83.7%
22
78.6%
18. Secondary Outcome
Title Mortality (Group A)
Description Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and admitted <14 days) who die
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group A
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 43
Count of Participants [Participants]
21
48.8%
19. Secondary Outcome
Title Time From Transfusion to End of Ventilator Support (Group B)
Description Number of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)
Time Frame During hospitalization, a maximum of 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Measure Participants 28
Mean (Standard Deviation) [days]
6.25
(5.76)

Adverse Events

Time Frame 28 days
Adverse Event Reporting Description
Arm/Group Title Group A Group B
Arm/Group Description Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit Hospitalized COVID-19 patients ages ≥18 years requiring intubation. COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
All Cause Mortality
Group A Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 24/43 (55.8%) 20/28 (71.4%)
Serious Adverse Events
Group A Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 24/43 (55.8%) 20/28 (71.4%)
Blood and lymphatic system disorders
Bleeding or low hemoglobin 1/43 (2.3%) 1 0/28 (0%) 0
Cardiac disorders
Cardio-circulatory arrest 1/43 (2.3%) 1 7/28 (25%) 7
Infections and infestations
Sepsis 1/43 (2.3%) 1 1/28 (3.6%) 1
Nervous system disorders
Neurological 0/43 (0%) 0 3/28 (10.7%) 4
Respiratory, thoracic and mediastinal disorders
Respiratory failure 21/43 (48.8%) 29 13/28 (46.4%) 16
Other (Not Including Serious) Adverse Events
Group A Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/43 (7%) 4/28 (14.3%)
Blood and lymphatic system disorders
Bleeding 1/43 (2.3%) 1 1/28 (3.6%) 2
Low hemaglobin 2/43 (4.7%) 2 0/28 (0%) 0
Ear and labyrinth disorders
Deep right ear pain 0/43 (0%) 0 1/28 (3.6%) 1
Immune system disorders
Minor allergic reaction 0/43 (0%) 0 1/28 (3.6%) 1
Infections and infestations
Fever 0/43 (0%) 0 1/28 (3.6%) 1
Reproductive system and breast disorders
pneumomediastinum 1/43 (2.3%) 1 0/28 (0%) 0
Skin and subcutaneous tissue disorders
Anterior rectal tear 0/43 (0%) 0 1/28 (3.6%) 1

Limitations/Caveats

Early termination due to changes in the Emergency Use Authorization for plasma during COVID-19. All plasma was labeled either low titer or high titer. The protocol required untitered plasma be used, which resulted in inability to complete the study and early termination.

More Information

Certain Agreements

All Principal Investigators ARE 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/Title Matthew Sims, MD
Organization Beaumont Hospitals
Phone 248-551-0027
Email matthew.sims@beaumont.org
Responsible Party:
Matthew Sims, MD, PhD, Director Infectious Disease Research, Beaumont Health; Professor of Internal Medicine and Foundational Medical Studies, OUWB School of Medicine, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT04432272
Other Study ID Numbers:
  • 2020-198
First Posted:
Jun 16, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022