Use of Convalescent Plasma for COVID-19

COVID Clinical Trial

Official title:

Use of Convalescent Plasma Collected From Donors Recovered From COVID-19 Virus Disease for Transfusion, as an Empirical and Preemptive Treatment During Viral Pandemic Outbreak

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04408040
• Other study ID #: NSH 1281
• Status: Terminated
• Phase: Phase 2
• Start date: July 14, 2020
• Est. completion date: September 14, 2021

Study information

• Verified date: October 2022
• Source: Northside Hospital, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented COVID-19 infection by nasal pharyngeal sampling

• COVID-19 disease falling into one of the following groups:

• Critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure

• Severe disease: tachypnea >/=30 per min, O2 sats </=93% at rest, PaO2/FiO2 index </=300mmHg

• High Risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate to severe asthma history, severe COPD, morbid obesity (BMI >/=40, age >/=65 years

• Health Care Providers: health care providers at risk to exposure to COVID-19 infection or those with mild to non-severe disease

Exclusion Criteria:

• History of IgA deficiency

• History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy

Related Conditions & MeSH terms

• COVID

Intervention

Biological:
• Convalescent Plasma
200-425mL convalescent plasma donated by patients previously positive for COVID-19

Locations

Country	Name	City	State
United States	Northside Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Northside Hospital, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection	Number of patients who survived the covid infection after treatment on study.	30 days after initial treatment