Convalescent Plasma to Stem Coronavirus (CSSC-001)
Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT04323800
Collaborator
(none)
180
25
2
12.4
7.2
0.6
Study Details
Study Description
Brief Summary
Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This randomized, controlled, double-blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria). Adults 18 years of age and older with high risk exposure as defined by CDC may participate. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma).
Study Design
Study Type:
Interventional
Actual Enrollment
:
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:1 ratio1:1 ratio
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19
Actual Study Start Date
:
Jun 10, 2020
Actual Primary Completion Date
:
Apr 22, 2021
Actual Study Completion Date
:
Jun 22, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High titer anti-SARS-CoV-2 plasma Participants with High titer anti-SARS-CoV-2 plasma. |
Biological: 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
|
| Active Comparator: SARS-CoV-2 non-immune plasma Participants with SARS-CoV-2 non-immune plasma. |
Biological: SARS-CoV-2 non-immune Plasma
Normal human plasma collected prior to December 2019
|
Outcome Measures
Primary Outcome Measures
- Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection [Day 28]
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.
- Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With "Serious Adverse Events" [Up to Day 28]
Number of participants with serious adverse events categorized as either severe infusion reactions or Acute Respiratory Distress Syndrome during the study period.
- 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 [Up to Day 28]
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.
Secondary Outcome Measures
- Number of Participants With Severe Disease [Up to 28 days]
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: Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen non-ICU hospitalization, not requiring supplemental oxygen
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria
-
Subjects must be 18 years of age or older
-
Close contact exposure (as defined by CDC guidelines) to person with COVID-19 within 96 hours of randomization (and 120 hours of receipt of plasma)
Exclusion Criteria
-
Receipt of any blood product in past 120 days.
-
Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.
-
Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening.
-
Laboratory evidence of COVID-19 infection at time of screening.
-
History or known laboratory evidence of previous COVID-19 infection.
-
History of prior reactions to transfusion blood products.
-
Inability to complete therapy with the study product within 24 hours after randomization.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Center for American Indian Health - Whiteriver Office | Whiteriver | Arizona | United States | 85941 |
| 3 | University of California, San Diego | La Jolla | California | United States | 92093 |
| 4 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
| 5 | University of California, Irvine Health | Orange | California | United States | 92868 |
| 6 | Western Connecticut Health Network, Danbury Hospital | Danbury | Connecticut | United States | 06810 |
| 7 | Western Connecticut Health Netowrk, Norwalk Hospital | Norwalk | Connecticut | United States | 06856 |
| 8 | MedStar Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 9 | University of Miami | Coral Gables | Florida | United States | 33124 |
| 10 | University of Miami Clinical Translational Research Site | Miami | Florida | United States | 33136 |
| 11 | NorthShore University HealthSystem | Evanston | Illinois | United States | 60201 |
| 12 | Anne Arundel Medical Center | Annapolis | Maryland | United States | 21401 |
| 13 | The Johns Hopkins University | Baltimore | Maryland | United States | 21205 |
| 14 | University of Massachusetts Worcester | Worcester | Massachusetts | United States | 01655 |
| 15 | Wayne State University | Detroit | Michigan | United States | 48202 |
| 16 | University of New Mexico Health Sciences Center | Albuquerque | New Mexico | United States | 87131 |
| 17 | Center for American Indian Health - Gallup Office | Gallup | New Mexico | United States | 87301 |
| 18 | Center for American Indian Health - Shiprock Office | Shiprock | New Mexico | United States | 87420 |
| 19 | Vassar Brothers Medical Center | Poughkeepsie | New York | United States | 12601 |
| 20 | University of Rochester | Rochester | New York | United States | 14642 |
| 21 | University of Cincinnati Medical Center | Cincinnati | Ohio | United States | 45219 |
| 22 | Lifespan/BrownUniversity (Rhode Island Hospital) | Providence | Rhode Island | United States | 02903 |
| 23 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 24 | University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
| 25 | The University of Utah | Salt Lake City | Utah | United States | 84132 |
Sponsors and Collaborators
- Johns Hopkins University
Investigators
- Principal Investigator: Shmuel Shoham, MD, Johns Hopkins University
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04323800
Other Study ID Numbers:
- IRB00245634
First Posted:
Mar 27, 2020
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | High Titer Anti-SARS-CoV-2 Plasma | SARS-CoV-2 Non-immune Plasma |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | High Titer Anti-SARS-CoV-2 Plasma | SARS-CoV-2 Non-immune Plasma | Total |
|---|---|---|---|
| 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 Participants | 87 | 93 | 180 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
48
|
46
|
48
|
| Age, Customized (Count of Participants) | |||
| 18 - 34 years |
18
20.7%
|
26
28%
|
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 (Count of Participants) | |||
| Female |
41
47.1%
|
40
43%
|
81
45%
|
| Male |
46
52.9%
|
53
57%
|
99
55%
|
| Ethnicity (NIH/OMB) (Count of 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%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
2.3%
|
7
7.5%
|
9
5%
|
| Native Hawaiian or Other Pacific Islander |
1
1.1%
|
0
0%
|
1
0.6%
|
| Black or African American |
4
4.6%
|
6
6.5%
|
10
5.6%
|
| White |
80
92%
|
78
83.9%
|
158
87.8%
|
| More than one race |
0
0%
|
2
2.2%
|
2
1.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| BMI (Count of Participants) | |||
| <18 |
2
2.3%
|
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%
|
26
14.4%
|
| Number of people in household (Count of Participants) | |||
| 1 |
18
20.7%
|
26
28%
|
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%
|
| >/=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 (Count of Participants) | |||
| 1 |
54
62.1%
|
54
58.1%
|
108
60%
|
| 2 |
8
9.2%
|
5
5.4%
|
13
7.2%
|
| 3 |
1
1.1%
|
3
3.2%
|
4
2.2%
|
| >/=4 |
0
0%
|
1
1.1%
|
1
0.6%
|
| Missing |
24
27.6%
|
30
32.3%
|
54
30%
|
| Median time from last exposure to transfusion (hours) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [hours] |
2
|
3
|
3
|
| Days from last exposure to transfusion (Count of Participants) | |||
| 0 |
7
8%
|
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%
|
9
9.7%
|
16
8.9%
|
| Missing |
9
10.3%
|
9
9.7%
|
18
10%
|
| Not transfused |
5
5.7%
|
5
5.4%
|
10
5.6%
|
| Cancer Status (Count of Participants) | |||
| Active cancer |
1
1.1%
|
1
1.1%
|
2
1.1%
|
| Active cancer on chemotherapy |
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%
|
158
87.8%
|
| Cardiac condition (Count of Participants) | |||
| Arrhythmia |
2
2.3%
|
1
1.1%
|
3
1.7%
|
| Atrial fibrillation, on anticoagulant |
1
1.1%
|
0
0%
|
1
0.6%
|
| Cardiomyopathy |
1
1.1%
|
0
0%
|
1
0.6%
|
| Coronary artery disease |
1
1.1%
|
3
3.2%
|
4
2.2%
|
| Myocardial infarction |
0
0%
|
2
2.2%
|
2
1.1%
|
| No cardiac condition |
82
94.3%
|
87
93.5%
|
169
93.9%
|
| Immunologic condition (Count of Participants) | |||
| Allergic rhinitis |
12
13.8%
|
10
10.8%
|
22
12.2%
|
| Inflammatory bowel disease |
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%
|
2
1.1%
|
| Immunosuppression or on other immune modulator |
1
1.1%
|
0
0%
|
1
0.6%
|
| No immunologic condition |
68
78.2%
|
74
79.6%
|
142
78.9%
|
| Metabolic condition (Count of 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%
|
87
93.5%
|
167
92.8%
|
| Respiratory condition (Count of Participants) | |||
| Asthma |
4
4.6%
|
5
5.4%
|
9
5%
|
| Chronic Bronchitis |
0
0%
|
2
2.2%
|
2
1.1%
|
| Chronic sinusitis |
0
0%
|
1
1.1%
|
1
0.6%
|
| Cough |
1
1.1%
|
1
1.1%
|
2
1.1%
|
| Pulmonary fibrosis |
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 (Count of 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%
|
Outcome Measures
| Title | Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | High Titer Anti-SARS-CoV-2 Plasma | SARS-CoV-2 Non-immune Plasma |
|---|---|---|
| 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 |
| Measure Participants | 81 | 87 |
| Count of Participants [Participants] |
12
13.8%
|
13
14%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | High Titer Anti-SARS-CoV-2 Plasma, SARS-CoV-2 Non-immune Plasma |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.42 |
| Comments | One-sided p-value | |
| Method | Restricted Mean Survival Test statistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.01 | |
| Confidence Interval |
(1-Sided) 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With "Serious Adverse Events" |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | High Titer Anti-SARS-CoV-2 Plasma | SARS-CoV-2 Non-immune Plasma |
|---|---|---|
| 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 |
| Measure Participants | 81 | 87 |
| Count of Participants [Participants] |
0
0%
|
1
1.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | High Titer Anti-SARS-CoV-2 Plasma, SARS-CoV-2 Non-immune Plasma |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.67 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | -5 | |
| Confidence Interval |
(2-Sided) 95% -31 to 19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| 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 |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | High Titer Anti-SARS-CoV-2 Plasma | SARS-CoV-2 Non-immune Plasma |
|---|---|---|
| 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 |
| Measure Participants | 81 | 87 |
| Number (95% Confidence Interval) [Events per 100 person-years] |
23
|
70
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | High Titer Anti-SARS-CoV-2 Plasma, SARS-CoV-2 Non-immune Plasma |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.06 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | -47 | |
| Confidence Interval |
(2-Sided) 95% -100 to 2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Severe Disease |
|---|---|
| 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: Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen non-ICU hospitalization, not requiring supplemental oxygen |
| Time Frame | Up to 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | High Titer Anti-SARS-CoV-2 Plasma | SARS-CoV-2 Non-immune Plasma |
|---|---|---|
| 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 |
| Measure Participants | 81 | 87 |
| Count of Participants [Participants] |
0
0%
|
2
2.2%
|
Adverse Events
| 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 | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/81 (0%) | 0/87 (0%) | ||
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 (4.9%) | 14/87 (16.1%) | ||
| Blood and lymphatic system disorders | ||||
| Severe transfusion reaction | 0/81 (0%) | 0 | 1/87 (1.1%) | 1 |
| General disorders | ||||
| Grade 3 or 4 adverse events | 4/81 (4.9%) | 4 | 13/87 (14.9%) | 13 |
Other (Not Including 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 | 24/81 (29.6%) | 44/87 (50.6%) | ||
| General disorders | ||||
| Non-serious adverse events | 24/81 (29.6%) | 24 | 44/87 (50.6%) | 44 |
Limitations/Caveats
[Not Specified]
More Information
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
| Name/Title | Shmuel Shoham |
|---|---|
| Organization | The Johns Hopkins University School of Medicine |
| Phone | 410-614-6431 |
| sshoham1@jhmi.edu |
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04323800
Other Study ID Numbers:
- IRB00245634
First Posted:
Mar 27, 2020
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022