Use of Convalescent Plasma for COVID-19

• Sponsor: Northside Hospital, Inc. (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04408040
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arms: 4
• Actual Duration (Months): 14
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID	Biological: Convalescent Plasma	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 14, 2020
• Actual Primary Completion Date: Sep 14, 2021
• Actual Study Completion Date: Sep 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Critical Patients	Biological: Convalescent Plasma; 200-425mL convalescent plasma donated by patients previously positive for COVID-19
Other: Severe Patients	Biological: Convalescent Plasma; 200-425mL convalescent plasma donated by patients previously positive for COVID-19
Other: High Risk	Biological: Convalescent Plasma; 200-425mL convalescent plasma donated by patients previously positive for COVID-19
Other: Health Care Providers	Biological: Convalescent Plasma; 200-425mL convalescent plasma donated by patients previously positive for COVID-19

Outcome Measures

Primary Outcome Measures

1. Arms 1 & 2: number of critical and severe COVID-19 infected patients who are transfused with convalescent plasma result in lower death rates than the reported fatality rate [30 days after initial treatment]

   To estimate infection-related mortality rates

2. Arms 1 & 2: number of critical and severe COVID-19 infected patients who survive the infection [30 days after initial treatment]

   To estimate overall survival

3. Arm 3: number of high risk COVID-19 infected patients who are transfused with convalescent plasma result in lower incidence of progression to severe or critical disease than the reported case rate [30 days after initial treatment]

   To estimate progression incidence rates

4. Arm 4: number of health care providers who are at risk to exposure to COVID-19 who are transfused with convalescent plasma result in lower incidence of developing COVID-19 infection than the reported case rate [30 days after initial treatment]

   To estimate the rate of infection among healthy persons exposed to COVID-19

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northside Hospital	Atlanta	Georgia	United States	30342

Sponsors and Collaborators

• Northside Hospital, Inc.

Investigators

• Principal Investigator: Kent Holland, MD, Northside Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Northside Hospital, Inc.
• ClinicalTrials.gov Identifier: NCT04408040
• Other Study ID Numbers: NSH 1281
• First Posted: May 29, 2020
• Last Update Posted: Sep 20, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 20, 2021