Convalescent Plasma for the Treatment of COVID-19

NCT04389710 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 20D.379
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2

  Number of patients who are consented and ultimately receive convalescent plasma transfusion.

  1 year

Secondary Outcomes (12)

• Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19

  0, 1, 2, 3, 7, 14 days

• Length of hospital stay

  0, 1, 2, 3, 7, 14, 28, 60, and 90 days

• Length of Intensive Care Unit stay

  0, 1, 2, 3, 7, 14, 28, 60, and 90 days

• Length of intubation

  0, 1, 2, 3, 7, 14, 28, 60, and 90 days

• Survival to discharge

  0, 1, 2, 3, 7, 14, 28, 60, and 90 days

Study Arms (1)

Intervention Group

EXPERIMENTAL

Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr

Drug: Convalescent Plasma

Interventions

Convalescent Plasma DRUG

One to two units (200-600 mL) of ABO compatible COVID-19 convalescent plasma

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Age 18 years and older
• Laboratory confirmed diagnosis of SARS-CoV-2
• Admitted to an acute care facility for the treatment of COVID-19 complications
• Informed consent provided by patient or legally authorized representative
• Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
• Severe Disease defined as any of the following
• Dyspnea
• Respiratory rate \> 30/minute
• Oxygen saturation \<94%
• Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300
• Lung infiltrates \>50% within 24 to 48 hours
• Life-threatening disease defined as any of the following
• Respiratory failure
• Septic shock
• Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy

You may not qualify if:

• Receipt of pooled immunoglobulin in past 30 days
• Contraindication to transfusion or history of prior reactions to transfusion blood products

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

COVID-19

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

Study Design

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

Model Details: Provide access to COVID-19 convalescent plasma for patients infected with SARS-CoV-2 currently hospitalized in acute care facilities

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 15, 2020
• Study Start: April 15, 2020
• Primary Completion: November 3, 2020
• Study Completion: December 7, 2020
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

US (1)