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Convalescent Plasma to Stem Coronavirus (CSSC-001) (CSSC-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323800
Recruitment Status : Completed
First Posted : March 27, 2020
Results First Posted : April 22, 2022
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Coronavirus
Convalescence
Interventions Biological: Anti- SARS-CoV-2 Plasma
Biological: SARS-CoV-2 non-immune Plasma
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Titer Anti-SARS-CoV-2 Plasma SARS-CoV-2 Non-immune Plasma
Hide Arm/Group Description

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

Participants with SARS-CoV-2 non-immune plasma.

SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019

Period Title: Overall Study
Started 87 93
Completed 81 87
Not Completed 6 6
Reason Not Completed
Withdrawal by Subject             4             4
Incomplete transfusion             1             0
Other             0             1
Positive RT-PCR at transfusion             1             1
Arm/Group Title High Titer Anti-SARS-CoV-2 Plasma SARS-CoV-2 Non-immune Plasma Total
Hide Arm/Group Description

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

Participants with SARS-CoV-2 non-immune plasma.

SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019

Total of all reporting groups
Overall Number of Baseline Participants 87 93 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 87 participants 93 participants 180 participants
48
(19 to 82)
46
(18 to 91)
48
(18 to 91)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
18 - 34 years
18
  20.7%
26
  28.0%
44
  24.4%
35 - 44 years
19
  21.8%
18
  19.4%
37
  20.6%
45 - 54 years
22
  25.3%
19
  20.4%
41
  22.8%
55 - 64 years
14
  16.1%
16
  17.2%
30
  16.7%
>/=65 years
14
  16.1%
14
  15.1%
28
  15.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
Female
41
  47.1%
40
  43.0%
81
  45.0%
Male
46
  52.9%
53
  57.0%
99
  55.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
Hispanic or Latino
15
  17.2%
16
  17.2%
31
  17.2%
Not Hispanic or Latino
72
  82.8%
77
  82.8%
149
  82.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.3%
7
   7.5%
9
   5.0%
Native Hawaiian or Other Pacific Islander
1
   1.1%
0
   0.0%
1
   0.6%
Black or African American
4
   4.6%
6
   6.5%
10
   5.6%
White
80
  92.0%
78
  83.9%
158
  87.8%
More than one race
0
   0.0%
2
   2.2%
2
   1.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
BMI   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
<18
2
   2.3%
0
   0.0%
2
   1.1%
18-24.9
23
  26.4%
34
  36.6%
57
  31.7%
25-29.9
30
  34.5%
14
  15.1%
44
  24.4%
30-34.9
10
  11.5%
16
  17.2%
26
  14.4%
35-39.9
6
   6.9%
11
  11.8%
17
   9.4%
>/=40
3
   3.4%
5
   5.4%
8
   4.4%
Missing
13
  14.9%
13
  14.0%
26
  14.4%
[1]
Measure Description: Body Mass Index (BMI) of participants (Kg/m^2).
Number of people in household  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
1
18
  20.7%
26
  28.0%
44
  24.4%
2
19
  21.8%
21
  22.6%
40
  22.2%
3
17
  19.5%
15
  16.1%
32
  17.8%
4
17
  19.5%
10
  10.8%
27
  15.0%
>/=5
12
  13.8%
17
  18.3%
29
  16.1%
Missing
4
   4.6%
4
   4.3%
8
   4.4%
Number of household COVID-19 positives  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
1
54
  62.1%
54
  58.1%
108
  60.0%
2
8
   9.2%
5
   5.4%
13
   7.2%
3
1
   1.1%
3
   3.2%
4
   2.2%
>/=4
0
   0.0%
1
   1.1%
1
   0.6%
Missing
24
  27.6%
30
  32.3%
54
  30.0%
Median time from last exposure to transfusion  
Median (Inter-Quartile Range)
Unit of measure:  Hours
Number Analyzed 87 participants 93 participants 180 participants
2
(1 to 4)
3
(1 to 4)
3
(1 to 4)
Days from last exposure to transfusion  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
0
7
   8.0%
7
   7.5%
14
   7.8%
1
24
  27.6%
16
  17.2%
40
  22.2%
2
12
  13.8%
14
  15.1%
26
  14.4%
3
11
  12.6%
17
  18.3%
28
  15.6%
4
12
  13.8%
16
  17.2%
28
  15.6%
>/=5
7
   8.0%
9
   9.7%
16
   8.9%
Missing
9
  10.3%
9
   9.7%
18
  10.0%
Not transfused
5
   5.7%
5
   5.4%
10
   5.6%
Cancer Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
Active cancer
1
   1.1%
1
   1.1%
2
   1.1%
Active cancer on chemotherapy
0
   0.0%
1
   1.1%
1
   0.6%
Cancer in remission
6
   6.9%
5
   5.4%
11
   6.1%
Leukemia/Lymphoma
2
   2.3%
6
   6.5%
8
   4.4%
No cancer
78
  89.7%
80
  86.0%
158
  87.8%
Cardiac condition  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
Arrhythmia
2
   2.3%
1
   1.1%
3
   1.7%
Atrial fibrillation, on anticoagulant
1
   1.1%
0
   0.0%
1
   0.6%
Cardiomyopathy
1
   1.1%
0
   0.0%
1
   0.6%
Coronary artery disease
1
   1.1%
3
   3.2%
4
   2.2%
Myocardial infarction
0
   0.0%
2
   2.2%
2
   1.1%
No cardiac condition
82
  94.3%
87
  93.5%
169
  93.9%
Immunologic condition  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
Allergic rhinitis
12
  13.8%
10
  10.8%
22
  12.2%
Inflammatory bowel disease
0
   0.0%
3
   3.2%
3
   1.7%
HIV, on antiretroviral treatment
4
   4.6%
6
   6.5%
10
   5.6%
Psoriasis
2
   2.3%
0
   0.0%
2
   1.1%
Immunosuppression or on other immune modulator
1
   1.1%
0
   0.0%
1
   0.6%
No immunologic condition
68
  78.2%
74
  79.6%
142
  78.9%
Metabolic condition  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
Diabetes Mellitus
6
   6.9%
5
   5.4%
11
   6.1%
Vitamin D deficiency
1
   1.1%
1
   1.1%
2
   1.1%
No metabolic condition
80
  92.0%
87
  93.5%
167
  92.8%
Respiratory condition  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
Asthma
4
   4.6%
5
   5.4%
9
   5.0%
Chronic Bronchitis
0
   0.0%
2
   2.2%
2
   1.1%
Chronic sinusitis
0
   0.0%
1
   1.1%
1
   0.6%
Cough
1
   1.1%
1
   1.1%
2
   1.1%
Pulmonary fibrosis
0
   0.0%
1
   1.1%
1
   0.6%
Pulmonary hypertension
1
   1.1%
1
   1.1%
2
   1.1%
No respiratory condition
81
  93.1%
82
  88.2%
163
  90.6%
Tobacco use status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
Current tobacco user
2
   2.3%
1
   1.1%
3
   1.7%
Past tobacco user
1
   1.1%
4
   4.3%
5
   2.8%
No tobacco use
84
  96.6%
88
  94.6%
172
  95.6%
1.Primary Outcome
Title Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection
Hide Description 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.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Titer Anti-SARS-CoV-2 Plasma SARS-CoV-2 Non-immune Plasma
Hide Arm/Group Description:

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

Participants with SARS-CoV-2 non-immune plasma.

SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019

Overall Number of Participants Analyzed 81 87
Measure Type: Count of Participants
Unit of Measure: Participants
12
  14.8%
13
  14.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Titer Anti-SARS-CoV-2 Plasma, SARS-CoV-2 Non-immune Plasma
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments One-sided p-value
Method Restricted Mean Survival Test statistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.01
Estimation Comments [Not Specified]
2.Primary Outcome
Title Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With "Serious Adverse Events"
Hide Description Number of participants with serious adverse events categorized as either severe infusion reactions or Acute Respiratory Distress Syndrome during the study period.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Titer Anti-SARS-CoV-2 Plasma SARS-CoV-2 Non-immune Plasma
Hide Arm/Group Description:

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

Participants with SARS-CoV-2 non-immune plasma.

SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019

Overall Number of Participants Analyzed 81 87
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   1.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Titer Anti-SARS-CoV-2 Plasma, SARS-CoV-2 Non-immune Plasma
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -5
Confidence Interval (2-Sided) 95%
-31 to 19
Estimation Comments [Not Specified]
3.Primary Outcome
Title 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
Hide Description Cumulative 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.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Titer Anti-SARS-CoV-2 Plasma SARS-CoV-2 Non-immune Plasma
Hide Arm/Group Description:

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

Participants with SARS-CoV-2 non-immune plasma.

SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019

Overall Number of Participants Analyzed 81 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Events per 100 person-years
23
(6 to 61)
70
(37 to 120)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Titer Anti-SARS-CoV-2 Plasma, SARS-CoV-2 Non-immune Plasma
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -47
Confidence Interval (2-Sided) 95%
-100 to 2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Severe Disease
Hide Description

Number 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
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Titer Anti-SARS-CoV-2 Plasma SARS-CoV-2 Non-immune Plasma
Hide Arm/Group Description:

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

Participants with SARS-CoV-2 non-immune plasma.

SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019

Overall Number of Participants Analyzed 81 87
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
   2.3%
Time Frame Within 28 days
Adverse Event Reporting Description 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.
 
Arm/Group Title High Titer Anti-SARS-CoV-2 Plasma SARS-CoV-2 Non-immune Plasma
Hide Arm/Group Description

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

Participants with SARS-CoV-2 non-immune plasma.

SARS-CoV-2 non-immune Plasma: Normal human plasma collected prior to December 2019

All-Cause Mortality
High Titer Anti-SARS-CoV-2 Plasma SARS-CoV-2 Non-immune Plasma
Affected / at Risk (%) Affected / at Risk (%)
Total   0/81 (0.00%)      0/87 (0.00%)    
Hide Serious Adverse Events
High Titer Anti-SARS-CoV-2 Plasma SARS-CoV-2 Non-immune Plasma
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/81 (4.94%)      14/87 (16.09%)    
Blood and lymphatic system disorders     
Severe transfusion reaction * 1  0/81 (0.00%)  0 1/87 (1.15%)  1
General disorders     
Grade 3 or 4 adverse events * 1  4/81 (4.94%)  4 13/87 (14.94%)  13
1
Term from vocabulary, MedDRA unspecified
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Titer Anti-SARS-CoV-2 Plasma SARS-CoV-2 Non-immune Plasma
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/81 (29.63%)      44/87 (50.57%)    
General disorders     
Non-serious adverse events * 1  24/81 (29.63%)  24 44/87 (50.57%)  44
1
Term from vocabulary, MedDRA unspecified
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shmuel Shoham
Organization: The Johns Hopkins University School of Medicine
Phone: 410-614-6431
EMail: sshoham1@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04323800    
Other Study ID Numbers: IRB00245634
First Submitted: March 24, 2020
First Posted: March 27, 2020
Results First Submitted: April 20, 2022
Results First Posted: April 22, 2022
Last Update Posted: April 26, 2022