Trial Outcomes & Findings for Convalescent Plasma to Stem Coronavirus (CSSC-001) (NCT 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

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

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

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, Continuous	48 years n=99 Participants	46 years n=107 Participants	48 years n=206 Participants
Age, Customized 18 - 34 years	18 Participants n=99 Participants	26 Participants n=107 Participants	44 Participants n=206 Participants
Age, Customized 35 - 44 years	19 Participants n=99 Participants	18 Participants n=107 Participants	37 Participants n=206 Participants
Age, Customized 45 - 54 years	22 Participants n=99 Participants	19 Participants n=107 Participants	41 Participants n=206 Participants
Age, Customized 55 - 64 years	14 Participants n=99 Participants	16 Participants n=107 Participants	30 Participants n=206 Participants
Age, Customized >/=65 years	14 Participants n=99 Participants	14 Participants n=107 Participants	28 Participants n=206 Participants
Sex: Female, Male Female	41 Participants n=99 Participants	40 Participants n=107 Participants	81 Participants n=206 Participants
Sex: Female, Male Male	46 Participants n=99 Participants	53 Participants n=107 Participants	99 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=99 Participants	16 Participants n=107 Participants	31 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants n=99 Participants	77 Participants n=107 Participants	149 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 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	2 Participants n=99 Participants	7 Participants n=107 Participants	9 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Black or African American	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Race (NIH/OMB) White	80 Participants n=99 Participants	78 Participants n=107 Participants	158 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
BMI <18	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
BMI 18-24.9	23 Participants n=99 Participants	34 Participants n=107 Participants	57 Participants n=206 Participants
BMI 25-29.9	30 Participants n=99 Participants	14 Participants n=107 Participants	44 Participants n=206 Participants
BMI 30-34.9	10 Participants n=99 Participants	16 Participants n=107 Participants	26 Participants n=206 Participants
BMI 35-39.9	6 Participants n=99 Participants	11 Participants n=107 Participants	17 Participants n=206 Participants
BMI >/=40	3 Participants n=99 Participants	5 Participants n=107 Participants	8 Participants n=206 Participants
BMI Missing	13 Participants n=99 Participants	13 Participants n=107 Participants	26 Participants n=206 Participants
Number of people in household 1	18 Participants n=99 Participants	26 Participants n=107 Participants	44 Participants n=206 Participants
Number of people in household 2	19 Participants n=99 Participants	21 Participants n=107 Participants	40 Participants n=206 Participants
Number of people in household 3	17 Participants n=99 Participants	15 Participants n=107 Participants	32 Participants n=206 Participants
Number of people in household 4	17 Participants n=99 Participants	10 Participants n=107 Participants	27 Participants n=206 Participants
Number of people in household >/=5	12 Participants n=99 Participants	17 Participants n=107 Participants	29 Participants n=206 Participants
Number of people in household Missing	4 Participants n=99 Participants	4 Participants n=107 Participants	8 Participants n=206 Participants
Number of household COVID-19 positives 1	54 Participants n=99 Participants	54 Participants n=107 Participants	108 Participants n=206 Participants
Number of household COVID-19 positives 2	8 Participants n=99 Participants	5 Participants n=107 Participants	13 Participants n=206 Participants
Number of household COVID-19 positives 3	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Number of household COVID-19 positives >/=4	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Number of household COVID-19 positives Missing	24 Participants n=99 Participants	30 Participants n=107 Participants	54 Participants n=206 Participants
Median time from last exposure to transfusion	2 hours n=99 Participants	3 hours n=107 Participants	3 hours n=206 Participants
Days from last exposure to transfusion 0	7 Participants n=99 Participants	7 Participants n=107 Participants	14 Participants n=206 Participants
Days from last exposure to transfusion 1	24 Participants n=99 Participants	16 Participants n=107 Participants	40 Participants n=206 Participants
Days from last exposure to transfusion 2	12 Participants n=99 Participants	14 Participants n=107 Participants	26 Participants n=206 Participants
Days from last exposure to transfusion 3	11 Participants n=99 Participants	17 Participants n=107 Participants	28 Participants n=206 Participants
Days from last exposure to transfusion 4	12 Participants n=99 Participants	16 Participants n=107 Participants	28 Participants n=206 Participants
Days from last exposure to transfusion >/=5	7 Participants n=99 Participants	9 Participants n=107 Participants	16 Participants n=206 Participants
Days from last exposure to transfusion Missing	9 Participants n=99 Participants	9 Participants n=107 Participants	18 Participants n=206 Participants
Days from last exposure to transfusion Not transfused	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants
Cancer Status Active cancer	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Cancer Status Active cancer on chemotherapy	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Cancer Status Cancer in remission	6 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants
Cancer Status Leukemia/Lymphoma	2 Participants n=99 Participants	6 Participants n=107 Participants	8 Participants n=206 Participants
Cancer Status No cancer	78 Participants n=99 Participants	80 Participants n=107 Participants	158 Participants n=206 Participants
Cardiac condition Arrhythmia	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Cardiac condition Atrial fibrillation, on anticoagulant	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Cardiac condition Cardiomyopathy	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Cardiac condition Coronary artery disease	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Cardiac condition Myocardial infarction	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Cardiac condition No cardiac condition	82 Participants n=99 Participants	87 Participants n=107 Participants	169 Participants n=206 Participants
Immunologic condition Allergic rhinitis	12 Participants n=99 Participants	10 Participants n=107 Participants	22 Participants n=206 Participants
Immunologic condition Inflammatory bowel disease	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Immunologic condition HIV, on antiretroviral treatment	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Immunologic condition Psoriasis	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Immunologic condition Immunosuppression or on other immune modulator	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Immunologic condition No immunologic condition	68 Participants n=99 Participants	74 Participants n=107 Participants	142 Participants n=206 Participants
Metabolic condition Diabetes Mellitus	6 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants
Metabolic condition Vitamin D deficiency	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Metabolic condition No metabolic condition	80 Participants n=99 Participants	87 Participants n=107 Participants	167 Participants n=206 Participants
Respiratory condition Asthma	4 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants
Respiratory condition Chronic Bronchitis	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Respiratory condition Chronic sinusitis	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Respiratory condition Cough	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Respiratory condition Pulmonary fibrosis	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Respiratory condition Pulmonary hypertension	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Respiratory condition No respiratory condition	81 Participants n=99 Participants	82 Participants n=107 Participants	163 Participants n=206 Participants
Tobacco use status Current tobacco user	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Tobacco use status Past tobacco user	1 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants
Tobacco use status No tobacco use	84 Participants n=99 Participants	88 Participants n=107 Participants	172 Participants n=206 Participants

PRIMARY outcome

Timeframe: Day 28

Outcome measures

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 28

Number of participants with serious adverse events categorized as either severe infusion reactions or Acute Respiratory Distress Syndrome during the study period.

Outcome measures

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 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.

Outcome measures

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 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: 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

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

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

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