Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (CSSC-004)
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|ClinicalTrials.gov Identifier: NCT04373460|
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : January 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV 2||Biological: SARS-CoV-2 convalescent plasma Biological: Plasma from a volunteer donor||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1344 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||June 3, 2020|
|Estimated Primary Completion Date :||December 21, 2022|
|Estimated Study Completion Date :||January 31, 2023|
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
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 Name: Human coronavirus immune plasma (HCIP)
Active Comparator: Standard Control plasma
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.
Biological: Plasma from a volunteer donor
Plasma collected from a volunteer donor prior to December 31, 2019
- 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
- Cumulative incidence of treatment-related serious adverse events [ Time Frame: Up to day 28 ]Cumulative incidence of treatment-related serious adverse events categorized separately as either severe infusion reactions or Acute Respiratory Distress Syndrome (ARDS) during the study period.
- 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.
- 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.
- Time to SARS-CoV-2 Polymerase Chain Reaction (PCR) negativity [ Time Frame: Day 0, 14 and 28 ]Compare the rates and duration of SARS-CoV-2 RNA positivity (by RT-PCR) of nasopharyngeal or oropharyngeal fluid between active and control groups at days 0, 14 and 28
- Change in level of SARS-CoV-2 RNA [ Time Frame: Day 0, 14 and 28 ]Compare the levels of SARS-CoV-2 RNA between active and control groups at days 0, 14 and 28
- Change in oxygen saturation levels [ Time Frame: Day 0 to Day 28 (where available) ]Comparison of participant self-assessed blood oxygen saturation levels (in percentage oxygen) between treatment arms using pulse oximetry from Day 0 to Day 28.
- 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.
- 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.
- 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.
- 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
- 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.
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373460
|Contact: David J Sullivan, MDfirstname.lastname@example.org|
|Contact: David Sullivan, MDemail@example.com|
|Principal Investigator:||David J Sullivan, MD||The Johns Hopkins University|