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Virus Therapy

SARS-CoV-2 convalescent plasma for COVID-19 (CSSC-004 Trial)

Phase 2
Waitlist Available
Led By David J Sullivan, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 14, 28 and 90
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a possible treatment for coronavirus that involves using plasma from people who have recovered from the virus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 14, 28 and 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 14, 28 and 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative Incidence of Severe Infusion Reactions
Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS)
Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events
+1 more
Secondary study objectives
Serum SARS-CoV-2 Antibody Titers by Visit
Other study objectives
Impact of Convalescent Plasma on Outcome as Assessed by Change in Hospitalization Rate
Impact of Donor Antibody Titers on Hospitalization Rate of Convalescent Plasma Recipients
Number of Participants Who Died
+5 more

Side effects data

From 2022 Phase 2 trial • 1225 Patients • NCT04373460
2%
Pneumonia
2%
Infusion related reaction
2%
Urticaria
1%
Vasovagal reaction
1%
Sinus tachycardia
1%
Fever
1%
Non-cardiac chest pain
1%
Pharyngitis
1%
Urinary tract infection
1%
Headache
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
SARS-CoV-2 Convalescent Plasma
Standard Control Plasma

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SARS-CoV-2 convalescent plasmaExperimental Treatment1 Intervention
SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.
Group II: Standard Control plasmaActive Control1 Intervention
Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SARS-CoV-2 convalescent plasma
2020
Completed Phase 3
~1310

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
34,943 Total Patients Enrolled
4 Trials studying COVID-19
17,985 Patients Enrolled for COVID-19
National Center for Advancing Translational Sciences (NCATS)NIH
362 Previous Clinical Trials
411,239 Total Patients Enrolled
20 Trials studying COVID-19
266,272 Patients Enrolled for COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,320 Previous Clinical Trials
5,547,607 Total Patients Enrolled
82 Trials studying COVID-19
341,065 Patients Enrolled for COVID-19
~226 spots leftby Nov 2025
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