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History of Changes for Study: NCT04373460
Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (CSSC-004)
Latest version (submitted June 2, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 30, 2020 None (earliest Version on record)
2 May 14, 2020 Study Status
3 June 4, 2020 Study Status and Eligibility
4 June 11, 2020 Eligibility, Sponsor/Collaborators and Study Status
5 June 16, 2020 Recruitment Status, Study Status and Contacts/Locations
6 June 22, 2020 Contacts/Locations and Study Status
7 June 24, 2020 Contacts/Locations and Study Status
8 July 13, 2020 Contacts/Locations and Study Status
9 July 15, 2020 Contacts/Locations, Outcome Measures, Arms and Interventions, Sponsor/Collaborators and Study Status
10 July 17, 2020 Sponsor/Collaborators, Outcome Measures, Arms and Interventions and Study Status
11 July 22, 2020 Contacts/Locations and Study Status
12 July 27, 2020 Study Design, Eligibility, Study Description and Study Status
13 August 7, 2020 Contacts/Locations and Study Status
14 August 13, 2020 Contacts/Locations and Study Status
15 August 26, 2020 Contacts/Locations and Study Status
16 September 3, 2020 Study Status, Study Design and Study Identification
17 September 11, 2020 Contacts/Locations and Study Status
18 October 8, 2020 Contacts/Locations and Study Status
19 October 19, 2020 Contacts/Locations and Study Status
20 November 6, 2020 Contacts/Locations and Study Status
21 December 21, 2020 Study Status and Study Design
22 January 12, 2021 Study Description and Study Status
23 March 31, 2021 Contacts/Locations and Study Status
24 April 6, 2021 Contacts/Locations and Study Status
25 July 29, 2021 Contacts/Locations and Study Status
26 October 6, 2021 Recruitment Status, Contacts/Locations and Study Status
27 November 15, 2021 Arms and Interventions, Eligibility, Study Design, Study Description, Sponsor/Collaborators and Study Status
28 June 2, 2022 Study Status, Outcome Measures, Study Design, References and Study Identification
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Study NCT04373460
Submitted Date:  April 30, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: IRB00247590
Brief Title: Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (CSSC-004)
Official Title: Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune) Plasma Among Outpatients With Symptomatic COVID-19.
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Overall Status: Not yet recruiting
Study Start: May 11, 2020
Primary Completion: December 21, 2022 [Anticipated]
Study Completion: January 31, 2023 [Anticipated]
First Submitted: April 30, 2020
First Submitted that
Met QC Criteria:
April 30, 2020
First Posted: May 4, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 30, 2020
Last Update Posted: May 4, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Johns Hopkins University
Responsible Party: Sponsor
Collaborators: State of Maryland
Bloomberg Foundation
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.
Detailed Description: The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 1344 eligible subjects stratified 50:50 in the <65 vs > 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
Open or close this module Conditions
Conditions: SARS-CoV 2
Keywords: COVID-19
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
A total of approximately 1344 eligible subjects stratified 50:50 in the <65 vs > 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 1344 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: SARS-CoV-2 convalescent plasma
SARS-CoV-2 convalescent plasma (1 cup; ~200-250 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 or current FDA standard titer for COVID-19
Biological: SARS-CoV-2 convalescent plasma
Plasma collected by apheresis from a volunteer donor who has recovered from COVID-19 and who has SARS-CoV-2 antibody (titer ≥ 1:320 or current FDA standard titer)
Other Names:
  • Human coronavirus immune plasma (HCIP)
Active Comparator: Standard Control plasma
SARS-CoV-2 non-immune control plasma collected prior to December 2019
Biological: Plasma from a volunteer donor
Plasma collected from a volunteer donor prior to December 31, 2019
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Cumulative incidence of hospitalization or death prior to hospitalization
[ Time Frame: Up to day 28 ]

Cumulative incidence measured as the proportion of subjects who were hospitalized or who died prior to hospitalization
2. Cumulative incidence of treatment-related serious adverse events
[ Time Frame: Up to day 28 ]

Cumulative incidence measured as the proportion of subjects experiencing an Serious Adverse Event (SAE).
3. Cumulative incidence of treatment-related grade 3 or higher adverse events
[ Time Frame: Up to day 90 ]

Cumulative incidence measured as the proportion of subjects experiencing a Grade 3 or higher.
Secondary Outcome Measures:
1. Change in serum SARS-CoV-2 antibody titers
[ Time Frame: Days 0, 14, 28 and 90 ]

Analysis of serum SARS-CoV-2 antibody titers will also primarily be descriptive, comparing the geometric mean titers at day 0, 14, 28 and 90 between the randomized arms and calculating the shift or change in the titer distribution.
2. Time to SARS-CoV-2 Polymerase Chain Reaction (PCR) negativity
[ Time Frame: Up to day 28 ]

Duration in days of SARS-CoV-2 PCR time to negativity will be analyzed by calculating the number of days taken for a positive participant to lose positivity from day 0 to day 28.
Other Outcome Measures:
1. Change in level of SARS-CoV-2 RNA
[ Time Frame: Day 0 to Day 28 ]

Change in levels of SARS-CoV-2 RNA between randomized arms from Day 0 to Day 28.
2. Change in oxygen saturation levels
[ Time Frame: Day 0 to Day 28 ]

Comparison of participant self-assessed blood oxygen saturation levels (in percentage oxygen) between treatment arms using pulse oximetry from Day 0 to Day 28.
3. Rate of participant-reported secondary infection of housemates
[ Time Frame: Up to day 90 ]

Secondary infection will be assessed by measuring the number of individuals that live in the same house as the active arm who became sick by the end of follow-up period.
4. Time to ICU admission, invasive mechanical ventilation or death in hospital
[ Time Frame: Up to day 90 ]

Disease severity measured by time (in days) to admission to the ICU or , invasive mechanical ventilation or time to death.
5. Time to resolution of COVID-19 symptoms
[ Time Frame: Up to day 90 ]

Time (in days) to resolution of COVID-19 symptoms will be based on temperature logs and symptom score sheets.
6. Impact of convalescent plasma on outcome as assessed by change in hospitalization rate
[ Time Frame: Day 0 to Day 90 ]

Assess change in hospitalization rate as measured by number of hospitalizations stratified by age groups <65 and >=65
7. Impact of donor antibody titers on hospitalizaton rate of convalescent plasma recipients
[ Time Frame: Day 0 to Day 90 ]

Impact of donor antibody titers (high/low) will be assessed by hospitalization rate as measured by number of hospitalizations.
8. Impact of donor antibody titers on antibody levels of convalescent plasma recipients
[ Time Frame: Day 0 to Day 90 ]

Impact of donor antibody titers (high/low) will be assessed by antibody levels
9. Impact of donor antibody titers on viral positivity rates of convalescent plasma recipients
[ Time Frame: Day 0 to Day 90 ]

Impact of donor antibody titers (high/low) will be assessed by viral positivity rates (number of SARS-CoV-2 positive cases per total cases)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • ≥ 18 years of age
  • Competent and capable to provide informed consent
  • Positive RNA test for presence of SARS-CoV-2 in fluid collected by oropharyngeal or nasopharyngeal swab
  • Experiencing any symptoms of COVID-19 including but not limited to fever(T> 100.5º F), cough, or other COVID associated symptoms like anosmia
  • ≤ 8 days since the first symptoms of COVID-19
  • ≤ 8 days since first positive SARS-CoV-2 RNA test
  • Able and willing to comply with protocol requirements listed in the informed consent

Exclusion Criteria:

  • Hospitalized or expected to be hospitalized within 24 hours of enrollment
  • Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance
  • History of prior reactions to transfusion blood products
  • Inability to complete therapy with the study product within 24 hours after enrollment
  • Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation (off label like hydroxychloroquine, compassionate use or study trial related)
Open or close this module Contacts/Locations
Central Contact Person: David J Sullivan, MD
Telephone: 410-502-2522
Email: dsulliv7@jhmi.edu
Central Contact Backup: David Sullivan, MD
Telephone: 410-502-2522
Email: dsulliv7@jhmi.edu
Study Officials: David J Sullivan, MD
Principal Investigator
The Johns Hopkins University
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
Anonymized individual participant data (IPD) collected in this study, including data dictionaries, will be made available to other researchers after the end of the study.
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame:
After publication of initial study manuscript
Access Criteria:
Public
URL:
Open or close this module References
Links:
Available IPD/Information:

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