FindTrial
Sign In

Convalescent Plasma to Stem Coronavirus (CSSC-001)

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04323800
Acronym
CSSC-001
Enrollment
180
Registered
2020-03-27
Start date
2020-06-10
Completion date
2021-06-22
Last updated
2022-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Convalescence, Coronavirus

Keywords

COVID-19

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.

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).

Interventions

BIOLOGICALAnti- 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

BIOLOGICALSARS-CoV-2 non-immune Plasma

Normal human plasma collected prior to December 2019

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

1:1 ratio

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Subjects must be 18 years of age or older 2. 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

1. Receipt of any blood product in past 120 days. 2. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance. 3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening. 4. Laboratory evidence of COVID-19 infection at time of screening. 5. History or known laboratory evidence of previous COVID-19 infection. 6. History of prior reactions to transfusion blood products. 7. Inability to complete therapy with the study product within 24 hours after randomization.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 InfectionDay 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.
Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With Serious Adverse EventsUp to Day 28Number 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 EventsUp 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.

Secondary

MeasureTime frameDescription
Number of Participants With Severe DiseaseUp 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

Countries

United States

Participant flow

Participants by arm

ArmCount
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
87
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
93
Total180

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyIncomplete transfusion10
Overall StudyOther01
Overall StudyPositive RT-PCR at transfusion11
Overall StudyWithdrawal by Subject44

Baseline characteristics

CharacteristicHigh Titer Anti-SARS-CoV-2 PlasmaSARS-CoV-2 Non-immune PlasmaTotal
Age, Continuous48 years46 years48 years
Age, Customized
18 - 34 years
18 Participants26 Participants44 Participants
Age, Customized
35 - 44 years
19 Participants18 Participants37 Participants
Age, Customized
45 - 54 years
22 Participants19 Participants41 Participants
Age, Customized
55 - 64 years
14 Participants16 Participants30 Participants
Age, Customized
>/=65 years
14 Participants14 Participants28 Participants
BMI
<18
2 Participants0 Participants2 Participants
BMI
18-24.9
23 Participants34 Participants57 Participants
BMI
25-29.9
30 Participants14 Participants44 Participants
BMI
30-34.9
10 Participants16 Participants26 Participants
BMI
35-39.9
6 Participants11 Participants17 Participants
BMI
>/=40
3 Participants5 Participants8 Participants
BMI
Missing
13 Participants13 Participants26 Participants
Cancer Status
Active cancer
1 Participants1 Participants2 Participants
Cancer Status
Active cancer on chemotherapy
0 Participants1 Participants1 Participants
Cancer Status
Cancer in remission
6 Participants5 Participants11 Participants
Cancer Status
Leukemia/Lymphoma
2 Participants6 Participants8 Participants
Cancer Status
No cancer
78 Participants80 Participants158 Participants
Cardiac condition
Arrhythmia
2 Participants1 Participants3 Participants
Cardiac condition
Atrial fibrillation, on anticoagulant
1 Participants0 Participants1 Participants
Cardiac condition
Cardiomyopathy
1 Participants0 Participants1 Participants
Cardiac condition
Coronary artery disease
1 Participants3 Participants4 Participants
Cardiac condition
Myocardial infarction
0 Participants2 Participants2 Participants
Cardiac condition
No cardiac condition
82 Participants87 Participants169 Participants
Days from last exposure to transfusion
0
7 Participants7 Participants14 Participants
Days from last exposure to transfusion
1
24 Participants16 Participants40 Participants
Days from last exposure to transfusion
2
12 Participants14 Participants26 Participants
Days from last exposure to transfusion
3
11 Participants17 Participants28 Participants
Days from last exposure to transfusion
4
12 Participants16 Participants28 Participants
Days from last exposure to transfusion
>/=5
7 Participants9 Participants16 Participants
Days from last exposure to transfusion
Missing
9 Participants9 Participants18 Participants
Days from last exposure to transfusion
Not transfused
5 Participants5 Participants10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants16 Participants31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
72 Participants77 Participants149 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Immunologic condition
Allergic rhinitis
12 Participants10 Participants22 Participants
Immunologic condition
HIV, on antiretroviral treatment
4 Participants6 Participants10 Participants
Immunologic condition
Immunosuppression or on other immune modulator
1 Participants0 Participants1 Participants
Immunologic condition
Inflammatory bowel disease
0 Participants3 Participants3 Participants
Immunologic condition
No immunologic condition
68 Participants74 Participants142 Participants
Immunologic condition
Psoriasis
2 Participants0 Participants2 Participants
Median time from last exposure to transfusion2 hours3 hours3 hours
Metabolic condition
Diabetes Mellitus
6 Participants5 Participants11 Participants
Metabolic condition
No metabolic condition
80 Participants87 Participants167 Participants
Metabolic condition
Vitamin D deficiency
1 Participants1 Participants2 Participants
Number of household COVID-19 positives
1
54 Participants54 Participants108 Participants
Number of household COVID-19 positives
2
8 Participants5 Participants13 Participants
Number of household COVID-19 positives
3
1 Participants3 Participants4 Participants
Number of household COVID-19 positives
>/=4
0 Participants1 Participants1 Participants
Number of household COVID-19 positives
Missing
24 Participants30 Participants54 Participants
Number of people in household
1
18 Participants26 Participants44 Participants
Number of people in household
2
19 Participants21 Participants40 Participants
Number of people in household
3
17 Participants15 Participants32 Participants
Number of people in household
4
17 Participants10 Participants27 Participants
Number of people in household
>/=5
12 Participants17 Participants29 Participants
Number of people in household
Missing
4 Participants4 Participants8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants7 Participants9 Participants
Race (NIH/OMB)
Black or African American
4 Participants6 Participants10 Participants
Race (NIH/OMB)
More than one race
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
80 Participants78 Participants158 Participants
Respiratory condition
Asthma
4 Participants5 Participants9 Participants
Respiratory condition
Chronic Bronchitis
0 Participants2 Participants2 Participants
Respiratory condition
Chronic sinusitis
0 Participants1 Participants1 Participants
Respiratory condition
Cough
1 Participants1 Participants2 Participants
Respiratory condition
No respiratory condition
81 Participants82 Participants163 Participants
Respiratory condition
Pulmonary fibrosis
0 Participants1 Participants1 Participants
Respiratory condition
Pulmonary hypertension
1 Participants1 Participants2 Participants
Sex: Female, Male
Female
41 Participants40 Participants81 Participants
Sex: Female, Male
Male
46 Participants53 Participants99 Participants
Tobacco use status
Current tobacco user
2 Participants1 Participants3 Participants
Tobacco use status
No tobacco use
84 Participants88 Participants172 Participants
Tobacco use status
Past tobacco user
1 Participants4 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 810 / 87
other
Total, other adverse events
24 / 8144 / 87
serious
Total, serious adverse events
4 / 8114 / 87

Outcome results

Primary

Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
High Titer Anti-SARS-CoV-2 PlasmaEfficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection12 Participants
SARS-CoV-2 Non-immune PlasmaEfficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection13 Participants
p-value: 0.42Restricted Mean Survival Test statistic
Primary

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

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

ArmMeasureValue (NUMBER)
High Titer Anti-SARS-CoV-2 PlasmaSafety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Cumulative Incidence of Grade 3 and 4 Adverse Events23 Events per 100 person-years
SARS-CoV-2 Non-immune PlasmaSafety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Cumulative Incidence of Grade 3 and 4 Adverse Events70 Events per 100 person-years
p-value: 0.0695% CI: [-100, 2]Chi-squared
Primary

Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With Serious Adverse Events

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
High Titer Anti-SARS-CoV-2 PlasmaSafety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With Serious Adverse Events0 Participants
SARS-CoV-2 Non-immune PlasmaSafety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With Serious Adverse Events1 Participants
p-value: 0.6795% CI: [-31, 19]Chi-squared
Secondary

Number of Participants With Severe Disease

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
High Titer Anti-SARS-CoV-2 PlasmaNumber of Participants With Severe Disease0 Participants
SARS-CoV-2 Non-immune PlasmaNumber of Participants With Severe Disease2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026