Trial Outcomes & Findings for Convalescent Plasma to Stem Coronavirus (CSSC-001) (NCT NCT04323800)
NCT ID: NCT04323800
Last Updated: 2022-04-26
Results Overview
Comparison of proportions of cumulative incidence of development of SARS-Cov-2 infection (symptoms compatible with infection and/or + molecular testing) regardless of disease severity, following high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
Day 28
Results posted on
2022-04-26
Participant Flow
Participant milestones
| Measure |
High Titer Anti-SARS-CoV-2 Plasma
Participants with High titer anti-SARS-CoV-2 plasma.
Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; \~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
|
SARS-CoV-2 Non-immune Plasma
Participants with SARS-CoV-2 non-immune plasma.
SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
93
|
|
Overall Study
COMPLETED
|
81
|
87
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
High Titer Anti-SARS-CoV-2 Plasma
Participants with High titer anti-SARS-CoV-2 plasma.
Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; \~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
|
SARS-CoV-2 Non-immune Plasma
Participants with SARS-CoV-2 non-immune plasma.
SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Incomplete transfusion
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
|
Overall Study
Positive RT-PCR at transfusion
|
1
|
1
|
Baseline Characteristics
Convalescent Plasma to Stem Coronavirus (CSSC-001)
Baseline characteristics by cohort
| Measure |
High Titer Anti-SARS-CoV-2 Plasma
n=87 Participants
Participants with High titer anti-SARS-CoV-2 plasma.
Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; \~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
|
SARS-CoV-2 Non-immune Plasma
n=93 Participants
Participants with SARS-CoV-2 non-immune plasma.
SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>/=65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Continuous
|
48 years
n=5 Participants
|
46 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Age, Customized
18 - 34 years
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Customized
35 - 44 years
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Customized
45 - 54 years
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Customized
55 - 64 years
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
<18
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
BMI
18-24.9
|
23 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
BMI
25-29.9
|
30 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
BMI
30-34.9
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
BMI
35-39.9
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
BMI
>/=40
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
BMI
Missing
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Number of people in household
1
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Number of people in household
2
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Number of people in household
3
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Number of people in household
4
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Number of people in household
>/=5
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Number of people in household
Missing
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Number of household COVID-19 positives
1
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Number of household COVID-19 positives
2
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Number of household COVID-19 positives
3
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Number of household COVID-19 positives
>/=4
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of household COVID-19 positives
Missing
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Median time from last exposure to transfusion
|
2 hours
n=5 Participants
|
3 hours
n=7 Participants
|
3 hours
n=5 Participants
|
|
Days from last exposure to transfusion
0
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Days from last exposure to transfusion
1
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Days from last exposure to transfusion
2
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Days from last exposure to transfusion
3
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Days from last exposure to transfusion
4
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Days from last exposure to transfusion
>/=5
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Days from last exposure to transfusion
Missing
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Days from last exposure to transfusion
Not transfused
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Cancer Status
Active cancer
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cancer Status
Active cancer on chemotherapy
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Status
Cancer in remission
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Cancer Status
Leukemia/Lymphoma
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Cancer Status
No cancer
|
78 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Cardiac condition
Arrhythmia
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Cardiac condition
Atrial fibrillation, on anticoagulant
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cardiac condition
Cardiomyopathy
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cardiac condition
Coronary artery disease
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cardiac condition
Myocardial infarction
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cardiac condition
No cardiac condition
|
82 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Immunologic condition
Allergic rhinitis
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Immunologic condition
Inflammatory bowel disease
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Immunologic condition
HIV, on antiretroviral treatment
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Immunologic condition
Psoriasis
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Immunologic condition
Immunosuppression or on other immune modulator
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Immunologic condition
No immunologic condition
|
68 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Metabolic condition
Diabetes Mellitus
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Metabolic condition
Vitamin D deficiency
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Metabolic condition
No metabolic condition
|
80 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Respiratory condition
Asthma
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Respiratory condition
Chronic Bronchitis
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Respiratory condition
Chronic sinusitis
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Respiratory condition
Cough
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Respiratory condition
Pulmonary fibrosis
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Respiratory condition
Pulmonary hypertension
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Respiratory condition
No respiratory condition
|
81 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Tobacco use status
Current tobacco user
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Tobacco use status
Past tobacco user
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Tobacco use status
No tobacco use
|
84 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Comparison of proportions of cumulative incidence of development of SARS-Cov-2 infection (symptoms compatible with infection and/or + molecular testing) regardless of disease severity, following high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19.
Outcome measures
| Measure |
High Titer Anti-SARS-CoV-2 Plasma
n=81 Participants
Participants with High titer anti-SARS-CoV-2 plasma.
Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; \~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
|
SARS-CoV-2 Non-immune Plasma
n=87 Participants
Participants with SARS-CoV-2 non-immune plasma.
SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019
|
|---|---|---|
|
Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection
|
12 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Number of participants with serious adverse events categorized as either severe infusion reactions or Acute Respiratory Distress Syndrome during the study period.
Outcome measures
| Measure |
High Titer Anti-SARS-CoV-2 Plasma
n=81 Participants
Participants with High titer anti-SARS-CoV-2 plasma.
Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; \~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
|
SARS-CoV-2 Non-immune Plasma
n=87 Participants
Participants with SARS-CoV-2 non-immune plasma.
SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019
|
|---|---|---|
|
Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With "Serious Adverse Events"
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Cumulative incidence of grade 3 and 4 adverse events during the study period evaluated as events per 100 person-years will be used to assess safety of the intervention.
Outcome measures
| Measure |
High Titer Anti-SARS-CoV-2 Plasma
n=81 Participants
Participants with High titer anti-SARS-CoV-2 plasma.
Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; \~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
|
SARS-CoV-2 Non-immune Plasma
n=87 Participants
Participants with SARS-CoV-2 non-immune plasma.
SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019
|
|---|---|---|
|
Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Cumulative Incidence of Grade 3 and 4 Adverse Events
|
23 Events per 100 person-years
Interval 6.0 to 61.0
|
70 Events per 100 person-years
Interval 37.0 to 120.0
|
SECONDARY outcome
Timeframe: Up to 28 daysNumber of participants with severe disease between the anti-SARS-CoV-2 convalescent plasma and control groups. Severity of disease will be measured using the number of participants with any of the disease severity categories below: 1. Death 2. Requiring mechanical ventilation and/or in ICU 3. non-ICU hospitalization, requiring supplemental oxygen 4. non-ICU hospitalization, not requiring supplemental oxygen
Outcome measures
| Measure |
High Titer Anti-SARS-CoV-2 Plasma
n=81 Participants
Participants with High titer anti-SARS-CoV-2 plasma.
Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; \~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
|
SARS-CoV-2 Non-immune Plasma
n=87 Participants
Participants with SARS-CoV-2 non-immune plasma.
SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019
|
|---|---|---|
|
Number of Participants With Severe Disease
|
0 Participants
|
2 Participants
|
Adverse Events
High Titer Anti-SARS-CoV-2 Plasma
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
SARS-CoV-2 Non-immune Plasma
Serious events: 14 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Titer Anti-SARS-CoV-2 Plasma
n=81 participants at risk
Participants with High titer anti-SARS-CoV-2 plasma.
Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; \~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
|
SARS-CoV-2 Non-immune Plasma
n=87 participants at risk
Participants with SARS-CoV-2 non-immune plasma.
SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019
|
|---|---|---|
|
Blood and lymphatic system disorders
Severe transfusion reaction
|
0.00%
0/81 • Within 28 days
Adverse events were evaluated among those transfused and not SARS Cov-2 positive at baseline. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
1.1%
1/87 • Number of events 1 • Within 28 days
Adverse events were evaluated among those transfused and not SARS Cov-2 positive at baseline. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
General disorders
Grade 3 or 4 adverse events
|
4.9%
4/81 • Number of events 4 • Within 28 days
Adverse events were evaluated among those transfused and not SARS Cov-2 positive at baseline. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
14.9%
13/87 • Number of events 13 • Within 28 days
Adverse events were evaluated among those transfused and not SARS Cov-2 positive at baseline. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
Other adverse events
| Measure |
High Titer Anti-SARS-CoV-2 Plasma
n=81 participants at risk
Participants with High titer anti-SARS-CoV-2 plasma.
Anti- SARS-CoV-2 Plasma: SARS-CoV-2 convalescent plasma (1 unit; \~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
|
SARS-CoV-2 Non-immune Plasma
n=87 participants at risk
Participants with SARS-CoV-2 non-immune plasma.
SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019
|
|---|---|---|
|
General disorders
Non-serious adverse events
|
29.6%
24/81 • Number of events 24 • Within 28 days
Adverse events were evaluated among those transfused and not SARS Cov-2 positive at baseline. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
50.6%
44/87 • Number of events 44 • Within 28 days
Adverse events were evaluated among those transfused and not SARS Cov-2 positive at baseline. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
Additional Information
Shmuel Shoham
The Johns Hopkins University School of Medicine
Phone: 410-614-6431
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place