Convalescent Plasma to Limit SARS-CoV-2 Associated Complications

SARS-CoV 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04373460
• Other study ID #: IRB00247590
• Secondary ID: R01AI152078W911Q
• Status: Completed
• Phase: Phase 2
• Start date: June 3, 2020
• Est. completion date: December 14, 2022

Study information

• Verified date: January 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 with a target goal (but not binding) of 50:50 in the <65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1225
• Est. completion date: December 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years of age

• Competent and capable to provide informed consent

• • Positive molecular test for presence of SARS-CoV-2 in fluid collected by saliva for antigen, 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 (monoclonal antibodies, compassionate use or study trial related). Steroid treatment at any time does not affect study eligibility

Related Conditions & MeSH terms

• SARS-CoV 2

Intervention

Biological:
• SARS-CoV-2 convalescent plasma
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.
• Plasma from a volunteer donor
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.

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	The Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Center for American Indian Health - Chinle Office	Chinle	Arizona
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	University of Miami	Coral Gables	Florida
United States	Western Connecticut Health Network, Danbury Hospital	Danbury	Connecticut
United States	Wayne State University	Detroit	Michigan
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Center for American Indian Health - Gallup Office	Gallup	New Mexico
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	MedStar Washington Hospital Center	Hyattsville	Maryland
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Miami Clinical Translational Research Site	Miami	Florida
United States	Tulane University	New Orleans	Louisiana
United States	Western Connecticut Health Network, Norwalk Hospital	Norwalk	Connecticut
United States	University of California, Irvine Health	Orange	California
United States	Mayo Clinic, Phoenix	Phoenix	Arizona
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Lifespan/BrownUniversity (Rhode Island Hospital)	Providence	Rhode Island
United States	University of Rochester	Rochester	New York
United States	The University of Utah	Salt Lake City	Utah
United States	Center for American Indian Health - Shiprock Office	Shiprock	New Mexico
United States	University of Arizona, Phoenix	Tucson	Arizona
United States	University of Arizona, Tuscon	Tucson	Arizona
United States	Center for American Indian Health - Whiteriver Office	Whiteriver	Arizona
United States	University of Massachusetts Worcester	Worcester	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins University	Bloomberg Foundation, National Center for Advancing Translational Sciences (NCATS), National Institute of Allergy and Infectious Diseases (NIAID), State of Maryland, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With ICU Admission	Disease severity measured by admission to the ICU	Up to day 90
Other	Number of Participants With Invasive Mechanical Ventilation	Disease severity measured by invasive mechanical ventilation	Up to day 90
Other	Number of Participants Who Died	Disease severity measured by death	Up to day 90
Other	Number of Participants With Resolved COVID-19 Symptoms at Day 14	Number of participants with resolved COVID-19 symptoms at day 14	Day 14
Other	Number of Participants With Resolved COVID-19 Symptoms at Day 28	Number of participants with resolved COVID-19 symptoms at day 28	Day 28
Other	Number of Participants With Resolved COVID-19 Symptoms at Day 90	Number of participants with resolved COVID-19 symptoms at day 90	Day 90
Other	Impact of Convalescent Plasma on Outcome as Assessed by Change in Hospitalization Rate	Assess change in hospitalization rate as measured by number of hospitalizations stratified by age groups <65 and >=65	Day 0 to Day 90
Other	Impact of Donor Antibody Titers on Hospitalization Rate of Convalescent Plasma Recipients	Impact of donor antibody titers (high/low) will be assessed by hospitalization rate as measured by number of hospitalizations.	Day 0 to Day28
Primary	Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization	Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization	Up to day 28
Primary	Cumulative Incidence of Severe Infusion Reactions	Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period.	Up to day 28
Primary	Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events	Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher.	Up to day 90
Primary	Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS)	Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period.	Up to day 28
Secondary	Serum SARS-CoV-2 Antibody Titers by Visit	Geometric mean Spike Receptor Binding Domain (RBD) titers at day 0, 14, 28 and 90 between the randomized arms.	Days 0, 14, 28 and 90