Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection

NCT04456413 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: Pro2020-0542
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

• This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.
• Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.
• Subjects will be randomized to receiving convalescent plasma or best supportive care.
• Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
• The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

Conditions

COVID-19

Keywords

Coronavirus; Covid19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Hospitalization Rate

  The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.

  10 Days

Secondary Outcomes (8)

• Time to Symptoms Resolution

  2 Months

• Overall Survival Rate

  2 Months

• Rate of Virologic Clearance by Nasopharyngeal Swab at 2 Weeks

  2 Weeks

• Rate of Nasopharyngeal Swab Positivity in Donors

  2 Months

• Rate of Donor Titers Level

  2 Months

Other Outcomes (12)

• Plasma Product's Cytokine Level Assessment

  Day 0

• Plasma Product's Mannose-binding Lectin (MBL) Level Assessment

  Day 0

• Plasma Product's Procalcitonin (PCT) Level Assessment

  Day 0

Study Arms (2)

Convalescent Plasma

EXPERIMENTAL

Fresh or frozen plasma will be infused one time to patients

Biological: Convalescent Plasma

Best Supportive Care

ACTIVE COMPARATOR

Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.

Other: Best Supportive Care

Interventions

Convalescent Plasma BIOLOGICAL

Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection

Convalescent Plasma

Best Supportive Care OTHER

Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.

Best Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• History of severe transfusion reaction to plasma products
• Need for oxygen supplementation
• Positive test for COVID-19 antibodies
• Chemotherapy-induced neutropenia (ANC \< 0.5 x 103/mcL)
• Immunosuppressive medications except for prednisone (or steroid equivalent) \> 10 mg daily.
• Performance status \< 50 by KPS
• Pneumonia by radiographic evaluation

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• United States Department of Defense: collaborator

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The convalescent plasma technology has been replaced by antivirals and monoclonal antibodies. Therefore, the study was not able to accrue successfully and was subsequently terminated. All available data (due to the lack of a formal analysis) is reported here.

Results Point of Contact

• Title: Joshua Zenreich
• Organization: Hackensack Meridian Health

Joshua.Zenreich@hmhn.org

551-996-4248

Study Officials

• Michele L Donato, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 2, 2020
• Study Start: November 6, 2020
• Primary Completion: April 29, 2021
• Study Completion: May 4, 2021
• Last Updated: October 10, 2023
• Results First Posted: February 10, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)