Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy

NCT04361253 | Terminated Phase 3 FDA Drug

• 1 other identifier: 2020P001215
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.

Conditions

COVID; Infectious Disease

Outcome Measures

Primary Outcomes (1)

• Modified WHO Ordinal Scale (MOS) score

  The primary outcome will be the MOS numerical score (score 0-9) where a score of 0 attributes to 'no clinical evidence of infection' and a score of 9 attributes to 'death'. The eligibility requirements for this trial select individuals at level 3 or higher on the modified scale, but the day 14 outcome can be any one of 10 levels.

  Day 14

Study Arms (2)

Arm A

EXPERIMENTAL

Two units of apheresis HT-CCP, collected from the same donor whenever possible, will be administered sequentially over no greater than a 24-hour period to participants randomized to Arm A. Each unit of HT-CCP will be approximately 250 mL, for a total transfused volume of approximately 500 mL.

Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP)

Arm B

PLACEBO COMPARATOR

Two units of FFP or FP24 (each 200-275 mL, approximately 500 mL total) will be administered sequentially to participants randomized to Arm B. (FFP/FP24 unit volumes vary more than apheresis plasma units. Two FFP/FP24 units that are approximately 250 mL apiece will be provided.)

Biological: Standard Plasma (FFP)

Interventions

High-Titer COVID-19 Convalescent Plasma (HT-CCP) BIOLOGICAL

250mL HT-CCP x2 doses given sequentially.

Arm A

Standard Plasma (FFP) BIOLOGICAL

250mL FFP or FP24 x2 doses given sequentially.

Arm B

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>1 year.
• Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR.
• Meets institutional criteria for admission to hospital for COVID-19.
• Admitted to ICU or non-ICU floor within 5 days of enrollment.
• PaO2/FiO2 \>200 mmHg if intubated.
• Patient or LAR able to provide informed consent.

You may not qualify if:

• Previous treatment with convalescent plasma for COVID-19.
• Current use of investigational antiviral therapy targeting SARS-CoV-2.
• History of anaphylactic transfusion reaction.
• Clinical diagnosis of acute decompensated heart failure.
• Objection to blood transfusion.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Kaufman, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 24, 2020
• Study Start: April 30, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 30, 2021
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months after study publication. No end date.
• Access Criteria: Proposals should be submitted to rmkaufman@bwh.harvard.edu.

Locations

US (1)