Study Stopped
New information regarding use of plasma in covid + patients
Use of Convalescent Plasma for COVID-19
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
1 other identifier
interventional
8
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2020
CompletedFirst Posted
Study publicly available on registry
May 29, 2020
CompletedStudy Start
First participant enrolled
July 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2021
CompletedResults Posted
Study results publicly available
November 14, 2022
CompletedNovember 14, 2022
October 1, 2022
1.2 years
May 15, 2020
November 23, 2021
October 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Critical Patients
OTHERSevere Patients
OTHERHigh Risk
OTHERHealth Care Providers
OTHERInterventions
200-425mL convalescent plasma donated by patients previously positive for COVID-19
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of IgA deficiency
- History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northside Hospital
Atlanta, Georgia, 30342, United States
Results Point of Contact
- Title
- H. Kent Holland, MD
- Organization
- Northside Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Kent Holland, MD
Northside Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2020
First Posted
May 29, 2020
Study Start
July 14, 2020
Primary Completion
September 14, 2021
Study Completion
September 14, 2021
Last Updated
November 14, 2022
Results First Posted
November 14, 2022
Record last verified: 2022-10