Convalescent Plasma as a Possible Treatment for COVID-19

NCT04442191 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2020-0441
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who are ill with COVID-19 may benefit from receiving convalescent plasma infusions containing antibodies from donors who have recovered from the disease and are proven to no longer be infected. Given the current public health emergency due to COVID-19, the FDA has recently fast-tracked the use of convalescent plasma. The purpose for this study is to assess if convalescent plasma collected from donors previously infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, can provide clinical benefit to those acutely ill with the virus and to evaluate if such treatment is safe. There will be two arms in the interventional study, where subjects will either be treated with convalescent plasma or fresh frozen plasma in a randomized and blinded manner. As an additional comparison, the clinical course of subjects enrolled during the period of the study who do not receive an alternative treatment for COVID-19 will be assessed.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Oxygen supplementation

  The primary endpoint will be clinical response at 8 days, defined as no need for oxygen supplementation for the previous 24 hours.

  8 days

Secondary Outcomes (12)

• 28-day and in-hospital mortality rate

  28 days

• Number of participants transferred to the Intensive Care Unit (ICU)

  28 days

• Number of participants intubated

  28 days

• Length of hospital stay in days

  28 days

• Type of respiratory support

  28 days

Other Outcomes (2)

• Safety endpoint: Severe transfusion reaction

  6 hours following transfusion

• Safety endpoint two: adverse events

  24 hours following transfusion

Study Arms (2)

Convalescent plasma

EXPERIMENTAL

This study will utilize convalescent plasma from donors recovered from infection with SARS-CoV-2 (which causes COVID-19) with neutralizing antibody titers \>1:64.

Biological: Convalescent plasma

Placebo

PLACEBO COMPARATOR

Placebo utilized in this study will include Fresh Frozen Plasma collected before the COVID-19 pandemic began. As an extra control, some of this plasma will be saved and tested for COVID-19 antibodies to ensure they are not present.

Biological: Placebo

Interventions

Convalescent plasma BIOLOGICAL

This study will use convalescent plasma collected from those who have previously had COVID-19 and have been shown to have cleared the infection and made antibodies against the virus.

Also known as: Fresh Frozen Plasma

Convalescent plasma

Placebo BIOLOGICAL

The placebo arm of this study will use fresh frozen plasma that presumably does not contain antibodies against COVID-19.

Also known as: Fresh Frozen Plasma

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 40 years-old and over who are admitted to the University of Illinois Hospital (UIC) due to COVID-19
• Positive oropharyngeal and/or nasopharyngeal swab test for SARS-CoV-2 by RT-PCR within the preceding 72 hours (performed by University of Illinois Hospital Laboratories or, if performed elsewhere, documented in the patient's UIC medical record)
• Symptomatic infection with any of the following: fever, cough, dyspnea, or tachypnea \> 22 breaths/min
• Need for supplemental oxygen, between 1-5 liters/minute by nasal canula, to maintain O2 saturations \>92%
• Consents to comply with all protocol requirements
• Agrees to storage of specimens for future testing

You may not qualify if:

• Patients with known Immunoglobulin A deficiency (high risk of severe or fatal anaphylactic reactions)
• Patients who are on a ventilator
• Patients with past history of severe transfusion reaction including transfusion-related acute lung injury (TRALI) or anaphylaxis
• Patients with a baseline requirement for supplemental oxygen due to chronic lung disease or with known history of either moderate-to-severe asthma or emphysema.
• Female subjects who report that they are pregnant or breastfeeding
• Receipt of pooled immunoglobulin in the past 30 days
• Patients must be willing to not take any another alternative experimental treatment for COVID-19 from the time they undergo enrollment until the 28-day follow-up phone call
• . Participants who are being treated with Remdesivir and have had their first dose of Remdesivir greater than 24 hours prior to the time they will receive their first dose of convalescent plasma
• Patients with severe disease due to COVID-19, as manifested by a need for vasopressors, and/or diagnosis of Acute Respiratory Distress Syndrome

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient's nurse will be instructed to place the blood product in a paper bag so the label on the product is not visible to the study physicians or to the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: June 22, 2020
• Study Start: May 5, 2020
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)