CoronavirusPhase 2CSSC-001NCT04323800

Convalescent Plasma to Stem Coronavirus (CSSC-001)

A Phase 2 study testing Anti- SARS-CoV-2 Plasma and SARS-CoV-2 non-immune Plasma in people with Coronavirus and Convalescence, run by Johns Hopkins University at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Coronavirus, Convalescence
What is being tested?: Anti- SARS-CoV-2 Plasma and SARS-CoV-2 non-immune Plasma
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 25 sitesUnited States
Study dates: 10 Jun 2020to 22 Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
Anne Arundel Medical Center
Annapolis, Maryland, 21401
The Johns Hopkins University
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
University of Miami
Coral Gables, Florida, 33124
Western Connecticut Health Network, Danbury Hospital
Danbury, Connecticut, 06810
Wayne State University
Detroit, Michigan, 48202
NorthShore University HealthSystem
Evanston, Illinois, 60201
Center for American Indian Health - Gallup Office
Gallup, New Mexico, 87301
Baylor College of Medicine
Houston, Texas, 77030
University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of California, San Diego
La Jolla, California, 92093
University of California, Los Angeles
Los Angeles, California, 90095
University of Miami Clinical Translational Research Site
Miami, Florida, 33136
Western Connecticut Health Netowrk, Norwalk Hospital
Norwalk, Connecticut, 06856
University of California, Irvine Health
Orange, California, 92868
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
Lifespan/BrownUniversity (Rhode Island Hospital)
Providence, Rhode Island, 02903
University of Rochester
Rochester, New York, 14642
The University of Utah
Salt Lake City, Utah, 84132
Center for American Indian Health - Shiprock Office
Shiprock, New Mexico, 87420
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Center for American Indian Health - Whiteriver Office
Whiteriver, Arizona, 85941
University of Massachusetts Worcester
Worcester, Massachusetts, 01655

Other trials in United States

About this study

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

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.

Read the 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).

Conditions: Coronavirus, Convalescence
Being tested: Anti- SARS-CoV-2 Plasma, SARS-CoV-2 non-immune Plasma
Keywords: COVID-19
Medical subject headings: Coronavirus Infections, Convalescence, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anti- SARS-CoV-2 PlasmaBiological
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 PlasmaBiological
Normal human plasma collected prior to December 2019

Study groups in NCT04323800
Study group	Role	What they receive
High titer anti-SARS-CoV-2 plasma	Experimental	Participants with High titer anti-SARS-CoV-2 plasma. Receives: Biological: Anti- SARS-CoV-2 Plasma
SARS-CoV-2 non-immune plasma	Active comparator	Participants with SARS-CoV-2 non-immune plasma. Receives: Biological: SARS-CoV-2 non-immune Plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 28
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.
Measured: Up to Day 28
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.
Measured: Up to Day 28

Secondary outcomes (1)

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
Measured: Up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 202022 Jun 2021

First posted27 Mar 2020
Study start10 Jun 2020
Primary completion22 Apr 2021
Study completion22 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for CoronavirusStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 1:1 ratio
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04323800
Sponsor's protocol ID: IRB00245634
Acronym: CSSC-001
Status last verified: Apr 2022
First submitted: 24 Mar 2020
Last updated: 26 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Sharing is governed by Johns Hopkins University Institutional Guidelines

Publications

Shoham S, Bloch EM, Casadevall A, Hanley D, Lau B, Gebo K, Cachay E, Kassaye SG, Paxton JH, Gerber J, Levine AC, Naeim A, Currier J, Patel B, Allen ES, Anjan S, Appel L, Baksh S, Blair PW, Bowen A, Broderick P, Caputo CA, Cluzet V, Cordisco ME, Cruser D, Ehrhardt S, Forthal D, Fukuta Y, Gawad AL, Gniadek T, Hammel J, Huaman MA, Jabs DA, Jedlicka A, Karlen N, Klein S, Laeyendecker O, Lane K, McBee N, Meisenberg B, Merlo C, Mosnaim G, Park HS, Pekosz A, Petrini J, Rausch W, Shade DM, Shapiro JR, Singleton JR, Sutcliffe C, Thomas DL, Yarava A, Zand M, Zenilman JM, Tobian AAR, Sullivan DJ. Transfusing Convalescent Plasma as Post-Exposure Prophylaxis Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Double-Blinded, Phase 2 Randomized, Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):e477-e486. doi: 10.1093/cid/ciac372.
PubMed 35579509
Shoham S, Bloch EM, Casadevall A, Hanley D, Lau B, Gebo K, Cachay E, Kassaye SG, Paxton JH, Gerber J, Levine AC, Currier J, Patel B, Allen ES, Anjan S, Appel L, Baksh S, Blair PW, Bowen A, Broderick P, Caputo CA, Cluzet V, Cordisco ME, Cruser D, Ehrhardt S, Forthal D, Fukuta Y, Gawad AL, Gniadek T, Hammel J, Huaman MA, Jabs DA, Jedlicka A, Karlen N, Klein S, Laeyendecker O, Lane K, McBee N, Meisenberg B, Merlo C, Mosnaim G, Park HS, Pekosz A, Petrini J, Rausch W, Shade DM, Shapiro JR, Singleton JR, Sutcliffe C, Thomas DL, Yarava A, Zand M, Zenilman JM, Tobian AAR, Sullivan D. Randomized controlled trial transfusing convalescent plasma as post-exposure prophylaxis against SARS-CoV-2 infection. medRxiv [Preprint]. 2021 Dec 14:2021.12.13.21267611. doi: 10.1101/2021.12.13.21267611.
PubMed 34931202

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04323800
Acronym / sponsor ID: CSSC-001 / IRB00245634
Conditions: Coronavirus, Convalescence
Keywords: COVID-19
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: 10 Jun 2020 (actual)
Primary completion: 22 Apr 2021 (actual)
Study completion: 22 Jun 2021 (actual)
First posted: 27 Mar 2020 (actual)
Results: Posted 22 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: 1:1 ratio

Arm	Type	Receives
High titer anti-SARS-CoV-2 plasma	Experimental	Biological: Anti- SARS-CoV-2 PlasmaParticipants with High titer anti-SARS-CoV-2 plasma.
SARS-CoV-2 non-immune plasma	Active comparator	Biological: SARS-CoV-2 non-immune PlasmaParticipants with SARS-CoV-2 non-immune plasma.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anti- SARS-CoV-2 PlasmaSARS-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	Biological	High titer anti-SARS-CoV-2 plasma
SARS-CoV-2 non-immune PlasmaNormal human plasma collected prior to December 2019	Biological	SARS-CoV-2 non-immune plasma

Primary outcome

Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection
Time frame: 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"
Time frame: 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
Time frame: 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.

1 secondary outcome

Number of Participants With Severe Disease
Time frame: Up to 28 days

Results and safety

Results posted to the registry on 22 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Titer Anti-SARS-CoV-2 Plasma	87	81
SARS-CoV-2 Non-immune Plasma	93	87

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

Time frame: Day 28. Count of participants. Unit: Participants

Measure	High Titer Anti-SARS-CoV-2 Plasma n = 81	SARS-CoV-2 Non-immune Plasma n = 87
Value	12	13

High Titer Anti-SARS-CoV-2 Plasma vs SARS-CoV-2 Non-immune Plasma: Risk Difference (RD): 0.01, p = 0.42, Restricted Mean Survival Test statistic

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

Time frame: Up to Day 28. Count of participants. Unit: Participants

Measure	High Titer Anti-SARS-CoV-2 Plasma n = 81	SARS-CoV-2 Non-immune Plasma n = 87
Value	0	1

High Titer Anti-SARS-CoV-2 Plasma vs SARS-CoV-2 Non-immune Plasma: Risk Difference (RD): -5 (95% CI -31 to 19), p = 0.67, Chi-squared

Primary outcome: 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

Time frame: Up to Day 28. Number (95% Confidence Interval). Unit: Events per 100 person-years

Measure	High Titer Anti-SARS-CoV-2 Plasma n = 81	SARS-CoV-2 Non-immune Plasma n = 87
Value	23 (6 to 61)	70 (37 to 120)

High Titer Anti-SARS-CoV-2 Plasma vs SARS-CoV-2 Non-immune Plasma: Risk Difference (RD): -47 (95% CI -100 to 2), p = 0.06, Chi-squared

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Within 28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Titer Anti-SARS-CoV-2 Plasma	4 of 81 (4.9%)	24 of 81 (29.6%)	0 of 81
SARS-CoV-2 Non-immune Plasma	14 of 87 (16.1%)	44 of 87 (50.6%)	0 of 87

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35579509Shoham S, Bloch EM, Casadevall A, Hanley D, Lau B, Gebo K, Cachay E, Kassaye SG, Paxton JH, Gerber J, Levine AC, Naeim A, Currier J, Patel B, Allen ES, Anjan S, Appel L, Baksh S, Blair PW, Bowen A, Broderick P, Caputo CA, Cluzet V, Cordisco ME, Cruser D, Ehrhardt S, Forthal D, Fukuta Y, Gawad AL, Gniadek T, Hammel J, Huaman MA, Jabs DA, Jedlicka A, Karlen N, Klein S, Laeyendecker O, Lane K, McBee N, Meisenberg B, Merlo C, Mosnaim G, Park HS, Pekosz A, Petrini J, Rausch W, Shade DM, Shapiro JR, Singleton JR, Sutcliffe C, Thomas DL, Yarava A, Zand M, Zenilman JM, Tobian AAR, Sullivan DJ. Transfusing Convalescent Plasma as Post-Exposure Prophylaxis Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Double-Blinded, Phase 2 Randomized, Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):e477-e486. doi: 10.1093/cid/ciac372.
Derived from this study: PubMed 34931202Shoham S, Bloch EM, Casadevall A, Hanley D, Lau B, Gebo K, Cachay E, Kassaye SG, Paxton JH, Gerber J, Levine AC, Currier J, Patel B, Allen ES, Anjan S, Appel L, Baksh S, Blair PW, Bowen A, Broderick P, Caputo CA, Cluzet V, Cordisco ME, Cruser D, Ehrhardt S, Forthal D, Fukuta Y, Gawad AL, Gniadek T, Hammel J, Huaman MA, Jabs DA, Jedlicka A, Karlen N, Klein S, Laeyendecker O, Lane K, McBee N, Meisenberg B, Merlo C, Mosnaim G, Park HS, Pekosz A, Petrini J, Rausch W, Shade DM, Shapiro JR, Singleton JR, Sutcliffe C, Thomas DL, Yarava A, Zand M, Zenilman JM, Tobian AAR, Sullivan D. Randomized controlled trial transfusing convalescent plasma as post-exposure prophylaxis against SARS-CoV-2 infection. medRxiv [Preprint]. 2021 Dec 14:2021.12.13.21267611. doi: 10.1101/2021.12.13.21267611.
Individual participant dataSharing planned: No. Sharing is governed by Johns Hopkins University Institutional Guidelines

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shmuel Shoham, MD principal investigator

Johns Hopkins University

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti- SARS-CoV-2 Plasma and SARS-CoV-2 non-immune Plasma in people with Coronavirus and Convalescence, run by Johns Hopkins University at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection (time frame: Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04323800, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.