CoVID-19 Plasma in Treatment of COVID-19 Patients

NCT04355897 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 20-23
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

The investigatores propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in patients requiring hospitalization for symptomatic "high risk" COVID19 disease as reflected by the presence of elevated hsTPN. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illness. Investigators hypothesize that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality and a key secondary objective to reduce the requirement for and/or duration of mechanical ventilation. Finally, as the hospital mortality for patients requiring mechanical ventilation is very high (50 to 80%), these patients will be eligible for COVID19 CP treatment as well, even in the absence of elevated hsTPN. Although considerable overlap of these populations has been observed (elevated hsTPN and requirement for mechanical ventilation) there is not 100% redundancy and it is hopeful that COVID19 CP may provide benefit to these critically ill patients.

Conditions

COVID 19

Outcome Measures

Primary Outcomes (1)

• Reduce mortality

  Reduce mortality of high risk COVID 19 disease compared with historic precedent cohorts (35-50%)

  At Day 28

Secondary Outcomes (3)

• Reduce requirement for mechanical ventilation.

  At Day 28

• Reduce the duration of mechanical ventilation.

  At Day 28

• Review of treatment related adverse events.

  At Day 28

Study Arms (1)

Convalescent COVID 19 Plasma

EXPERIMENTAL

Subjects will receive and intravenous infusion of 500 mls of Convalescent COVID 19 Plasma.

Biological: Convalescent COVID 19 Plasma

Interventions

Convalescent COVID 19 Plasma BIOLOGICAL

Subjects will be transfused intravenously with 500 mls of convalescent COVID 19 plasma

Convalescent COVID 19 Plasma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Symptomatic CoVID-19 disease requiring hospitalization
• SARS-CoV-19 PCR positive
• Elevated hsTPN

You may not qualify if:

• Multi-organ / system failure
• Renal insufficiency (eGFR \<30 or renal replacement therapy)
• Liver dysfunction (\>3x ULN SGOT / SGPT)
• Chronic Immunosuppression therapy
• Prior organ transplant
• Prior multiple transfusions for Myelodysplastic syndrome
• Prior treatment with plasma, immunoglobulin transfusion within 30 days
• Allergic reaction to blood/ plasma products
• Pregnant or breast feeding at the time of study
• Inability to provide informed consent

Sponsors & Collaborators

• The Christ Hospital: lead

Study Sites (2)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Dean J Kereiakes, MD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 21, 2020
• Study Start: April 28, 2020
• Primary Completion: July 6, 2020
• Study Completion: August 12, 2020
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)