Trial Outcomes & Findings for Convalescent Plasma in the Treatment of COVID 19 (NCT NCT04343261)
NCT ID: NCT04343261
Last Updated: 2020-09-24
Results Overview
Mortality within 28 days
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2020-09-24
Participant Flow
Participant milestones
| Measure |
COVID-19 Patients Treated With Convalescent Plasma
Severely ill COVID-19 patients treated with convalescent plasma
Convalescent Plasma: treatment with 2 Units of convalescent plasma
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
COVID-19 Patients Treated With Convalescent Plasma
Severely ill COVID-19 patients treated with convalescent plasma
Convalescent Plasma: treatment with 2 Units of convalescent plasma
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
received inadequate amount of antibodies
|
7
|
Baseline Characteristics
Convalescent Plasma in the Treatment of COVID 19
Baseline characteristics by cohort
| Measure |
COVID-19 Patients Treated With Convalescent Plasma
n=48 Participants
Severely ill COVID-19 patients treated with convalescent plasma
Convalescent Plasma: treatment with 2 Units of convalescent plasma
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 12.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: 48 patients with severe or life threatening disease with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection enrolled in the study. 7 patients were excluded from analysis due to receiving plasma with insufficient antibodies.
Mortality within 28 days
Outcome measures
| Measure |
COVID-19 Patients Treated With Convalescent Plasma
n=41 Participants
Severely ill COVID-19 patients treated with convalescent plasma
Convalescent Plasma: treatment with 2 Units of convalescent plasma
|
|---|---|
|
Mortality
|
19 Participants
|
PRIMARY outcome
Timeframe: Day 0, Day 3, Day 5, and Day 7Population: Plasma viral load data was available for 35 out of 41 convalescent plasma recipients on day 0. 22 patients out of 35 had non-detectable levels at Day 0; 25 patients out of 34 had non-detectable levels on Day 3; 20 patients out of 27 had non-detectable levels on Day 5; 20 patients out of 24 had non-detectable levels on Day 7.
Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).
Outcome measures
| Measure |
COVID-19 Patients Treated With Convalescent Plasma
n=35 Participants
Severely ill COVID-19 patients treated with convalescent plasma
Convalescent Plasma: treatment with 2 Units of convalescent plasma
|
|---|---|
|
Viral Load
Detectable Viral Load Day 0
|
3524 copies per mL
Interval 868.0 to 8315.0
|
|
Viral Load
Detectable Viral Load Day 3
|
2033 copies per mL
Interval 243.0 to 6386.0
|
|
Viral Load
Detectable Viral Load Day 5
|
315 copies per mL
Interval 214.0 to 4162.0
|
|
Viral Load
Detectable Viral Load Day 7
|
494 copies per mL
Interval 102.0 to 1292.0
|
PRIMARY outcome
Timeframe: Day 0, Day 3, Day 5, and Day 7Population: 39 out of 41 patients had blood collected on day 0 (pre-transfusion), and on post-transfusion day 3 (n=36), 5 (n=30), and 7 (n=24) and serum antibody titers was assessed at each time point.
Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is \> or = 1.0 arbitrary units/mL \[AU/mL\] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)
Outcome measures
| Measure |
COVID-19 Patients Treated With Convalescent Plasma
n=39 Participants
Severely ill COVID-19 patients treated with convalescent plasma
Convalescent Plasma: treatment with 2 Units of convalescent plasma
|
|---|---|
|
Serum Antibody Titers
SARS-CoV-2 Antibodies Day 0
|
18.5 arbitrary units/mL (AU/mL)
Interval 1.0 to 75.0
|
|
Serum Antibody Titers
SARS-CoV-2 Antibodies Day 3
|
37.2 arbitrary units/mL (AU/mL)
Interval 4.5 to 74.6
|
|
Serum Antibody Titers
SARS-CoV-2 Antibodies Day 5
|
47.4 arbitrary units/mL (AU/mL)
Interval 6.7 to 80.7
|
|
Serum Antibody Titers
SARS-CoV-2 Antibodies Day 7
|
55.2 arbitrary units/mL (AU/mL)
Interval 10.3 to 96.9
|
Adverse Events
COVID-19 Patients Treated With Convalescent Plasma
Serious events: 8 serious events
Other events: 8 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
COVID-19 Patients Treated With Convalescent Plasma
n=48 participants at risk
Severely ill COVID-19 patients treated with convalescent plasma
Convalescent Plasma: treatment with 2 Units of convalescent plasma
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Persistent Hypoxemia
|
2.1%
1/48 • Number of events 1 • Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).
Adverse event and/or serious adverse event related to treatment with convalescent plasma
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
4.2%
2/48 • Number of events 2 • Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).
Adverse event and/or serious adverse event related to treatment with convalescent plasma
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.1%
1/48 • Number of events 1 • Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).
Adverse event and/or serious adverse event related to treatment with convalescent plasma
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48 • Number of events 1 • Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).
Adverse event and/or serious adverse event related to treatment with convalescent plasma
|
|
Respiratory, thoracic and mediastinal disorders
Hypotension; Hypoxia
|
2.1%
1/48 • Number of events 1 • Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).
Adverse event and/or serious adverse event related to treatment with convalescent plasma
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax; subcutaneous emphysema
|
2.1%
1/48 • Number of events 1 • Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).
Adverse event and/or serious adverse event related to treatment with convalescent plasma
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
2.1%
1/48 • Number of events 1 • Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).
Adverse event and/or serious adverse event related to treatment with convalescent plasma
|
Other adverse events
| Measure |
COVID-19 Patients Treated With Convalescent Plasma
n=48 participants at risk
Severely ill COVID-19 patients treated with convalescent plasma
Convalescent Plasma: treatment with 2 Units of convalescent plasma
|
|---|---|
|
Immune system disorders
Fever
|
2.1%
1/48 • Number of events 1 • Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).
Adverse event and/or serious adverse event related to treatment with convalescent plasma
|
|
Product Issues
Insufficient Antibodies
|
14.6%
7/48 • Number of events 7 • Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).
Adverse event and/or serious adverse event related to treatment with convalescent plasma
|
Additional Information
Latha Dulipsingh, MD
Saint Francis Hospital and Medical Center
Phone: 860-714-4402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place