Trial Outcomes & Findings for ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS) (NCT NCT04432272)
NCT ID: NCT04432272
Last Updated: 2022-03-09
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
28 days
Results posted on
2022-03-09
Participant Flow
Participant milestones
| Measure |
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.
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
|
Group B
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
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
28
|
|
Overall Study
COMPLETED
|
43
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)
Baseline characteristics by cohort
| Measure |
Group A
n=43 Participants
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
|
Group B
n=28 Participants
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
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.95 years
STANDARD_DEVIATION 10.37 • n=99 Participants
|
62.83 years
STANDARD_DEVIATION 13.53 • n=107 Participants
|
68.96 years
STANDARD_DEVIATION 12.65 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=99 Participants
|
28 participants
n=107 Participants
|
71 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 28 daysCount 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
Outcome measures
| Measure |
Group A
n=43 Participants
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
|
Group B
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
|
|---|---|---|
|
Avoidance of Intubation at 28 Days (Group A)
|
26 Participants
|
—
|
PRIMARY outcome
Timeframe: 28 daysCount of group B participants (participants who are intubated at study entry) who die
Outcome measures
| Measure |
Group A
n=28 Participants
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
|
Group B
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
|
|---|---|---|
|
Mortality (Group B)
|
17 Participants
|
—
|
SECONDARY outcome
Timeframe: 28 daysCount of participants who experienced cardio-circulatory arrest
Outcome measures
| Measure |
Group A
n=43 Participants
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
|
Group B
n=28 Participants
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
|
|---|---|---|
|
Cardio-circulatory Arrest
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 28 daysPatient 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
Outcome measures
| Measure |
Group A
n=43 Participants
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
|
Group B
n=28 Participants
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
|
|---|---|---|
|
Patient Outcome at 28 Days
2 =Not hospitalized, limitation on activities
|
12 Participants
|
4 Participants
|
|
Patient Outcome at 28 Days
3= Hospitalized, not requiring supplemental oxygen
|
0 Participants
|
0 Participants
|
|
Patient Outcome at 28 Days
4 =Hospitalized, requiring supplemental oxygen
|
3 Participants
|
1 Participants
|
|
Patient Outcome at 28 Days
1= Not hospitalized, no limitations on activities
|
3 Participants
|
0 Participants
|
|
Patient Outcome at 28 Days
5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
2 Participants
|
1 Participants
|
|
Patient Outcome at 28 Days
6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
|
2 Participants
|
5 Participants
|
|
Patient Outcome at 28 Days
7=Deceased
|
21 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 28 daysCount 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.
Outcome measures
| Measure |
Group A
n=43 Participants
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
|
Group B
n=28 Participants
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
|
|---|---|---|
|
Renal Failure
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 28 daysCount 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%
Outcome measures
| Measure |
Group A
n=43 Participants
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
|
Group B
n=28 Participants
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
|
|---|---|---|
|
Liver Failure
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Data not available for 10 Group A participants and 8 group B participants
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)
Outcome measures
| Measure |
Group A
n=33 Participants
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
|
Group B
n=20 Participants
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
|
|---|---|---|
|
Cytokine Storm
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 28 daysCount 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.
Outcome measures
| Measure |
Group A
n=43 Participants
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
|
Group B
n=28 Participants
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
|
|---|---|---|
|
Respiratory Support
Ventilator
|
19 Participants
|
27 Participants
|
|
Respiratory Support
Coldflow
|
1 Participants
|
0 Participants
|
|
Respiratory Support
CPAP
|
11 Participants
|
2 Participants
|
|
Respiratory Support
BiPAP
|
25 Participants
|
4 Participants
|
|
Respiratory Support
Non-rebreather mask
|
19 Participants
|
3 Participants
|
|
Respiratory Support
Nasal cannula
|
27 Participants
|
8 Participants
|
|
Respiratory Support
High flow nasal cannula
|
37 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 28 daysCount of participants who received pressor drugs, as ordered by treating physicians
Outcome measures
| Measure |
Group A
n=43 Participants
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
|
Group B
n=28 Participants
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
|
|---|---|---|
|
Vasopressor Medication Support
|
19 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Analysis population is those participants in each group that entered the ICU
Length of ICU stay in days, for participants who entered ICU
Outcome measures
| Measure |
Group A
n=27 Participants
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
|
Group B
n=26 Participants
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
|
|---|---|---|
|
Length of ICU Length of Stay
|
17.59 days
Standard Deviation 10.16
|
22.12 days
Standard Deviation 10.37
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Data was not collected or analyzed for this outcome
Count of patients admitted to the ICU who die in ICU
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: Data not available for 1 Group B participants
Length of hospital stay in days
Outcome measures
| Measure |
Group A
n=43 Participants
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
|
Group B
n=27 Participants
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
|
|---|---|---|
|
Hospital Length of Stay
|
23.63 days
Standard Deviation 9.83
|
26.41 days
Standard Deviation 11.12
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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
Number of ventilator-free hospitalized days
Outcome measures
| Measure |
Group A
n=8 Participants
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
|
Group B
n=7 Participants
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
|
|---|---|---|
|
Ventilator Free Days
|
9.13 days
Standard Deviation 12.64
|
14.23 days
Standard Deviation 14.80
|
SECONDARY outcome
Timeframe: 28 daysLength of intubation, measured in days
Outcome measures
| Measure |
Group A
n=43 Participants
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
|
Group B
n=28 Participants
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
|
|---|---|---|
|
Intubation Duration
|
4.12 days
Standard Deviation 6.23
|
13.93 days
Standard Deviation 9.45
|
SECONDARY outcome
Timeframe: 90 daysCount of participants readmitted to hospital following index procedure hospital discharge
Outcome measures
| Measure |
Group A
n=43 Participants
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
|
Group B
n=28 Participants
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
|
|---|---|---|
|
Readmission
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During hospitalization, a maximum of 28 daysPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During hospitalization, a maximum of 28 daysPopulation: Data not available for 4 out of the 43 Group A participants. Data not available for 3 out of the 28 Group B participants.
Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.
Outcome measures
| Measure |
Group A
n=39 Participants
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
|
Group B
n=25 Participants
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
|
|---|---|---|
|
SARS-CoV-2 RNA
|
36 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 28 daysCount 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
Outcome measures
| Measure |
Group A
n=43 Participants
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
|
Group B
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
|
|---|---|---|
|
Mortality (Group A)
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: During hospitalization, a maximum of 28 daysNumber of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)
Outcome measures
| Measure |
Group A
n=28 Participants
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
|
Group B
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
|
|---|---|---|
|
Time From Transfusion to End of Ventilator Support (Group B)
|
6.25 days
Standard Deviation 5.76
|
—
|
Adverse Events
Group A
Serious events: 24 serious events
Other events: 3 other events
Deaths: 24 deaths
Group B
Serious events: 20 serious events
Other events: 4 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Group A
n=43 participants at risk
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
|
Group B
n=28 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Cardio-circulatory arrest
|
2.3%
1/43 • Number of events 1 • 28 days
|
25.0%
7/28 • Number of events 7 • 28 days
|
|
Nervous system disorders
Neurological
|
0.00%
0/43 • 28 days
|
10.7%
3/28 • Number of events 4 • 28 days
|
|
Blood and lymphatic system disorders
Bleeding or low hemoglobin
|
2.3%
1/43 • Number of events 1 • 28 days
|
0.00%
0/28 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
48.8%
21/43 • Number of events 29 • 28 days
|
46.4%
13/28 • Number of events 16 • 28 days
|
|
Infections and infestations
Sepsis
|
2.3%
1/43 • Number of events 1 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
Other adverse events
| Measure |
Group A
n=43 participants at risk
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
|
Group B
n=28 participants at risk
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
|
|---|---|---|
|
Reproductive system and breast disorders
pneumomediastinum
|
2.3%
1/43 • Number of events 1 • 28 days
|
0.00%
0/28 • 28 days
|
|
Blood and lymphatic system disorders
Bleeding
|
2.3%
1/43 • Number of events 1 • 28 days
|
3.6%
1/28 • Number of events 2 • 28 days
|
|
Blood and lymphatic system disorders
Low hemaglobin
|
4.7%
2/43 • Number of events 2 • 28 days
|
0.00%
0/28 • 28 days
|
|
Infections and infestations
Fever
|
0.00%
0/43 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
|
Skin and subcutaneous tissue disorders
Anterior rectal tear
|
0.00%
0/43 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
|
Ear and labyrinth disorders
Deep right ear pain
|
0.00%
0/43 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
|
Immune system disorders
Minor allergic reaction
|
0.00%
0/43 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place