Use of Convalescent Plasma for COVID-19
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ClinicalTrials.gov Identifier: NCT04408040 |
Recruitment Status :
Terminated
(New information regarding use of plasma in covid + patients)
First Posted : May 29, 2020
Last Update Posted : September 20, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID | Biological: Convalescent Plasma | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | July 14, 2020 |
Actual Primary Completion Date : | September 14, 2021 |
Actual Study Completion Date : | September 14, 2021 |

Arm | Intervention/treatment |
---|---|
Critical Patients |
Biological: Convalescent Plasma
200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
Severe Patients |
Biological: Convalescent Plasma
200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
High Risk |
Biological: Convalescent Plasma
200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
Health Care Providers |
Biological: Convalescent Plasma
200-425mL convalescent plasma donated by patients previously positive for COVID-19 |
- 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 [ Time Frame: 30 days after initial treatment ]To estimate infection-related mortality rates
- Arms 1 & 2: number of critical and severe COVID-19 infected patients who survive the infection [ Time Frame: 30 days after initial treatment ]To estimate overall survival
- 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 [ Time Frame: 30 days after initial treatment ]To estimate progression incidence rates
- 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 [ Time Frame: 30 days after initial treatment ]To estimate the rate of infection among healthy persons exposed to COVID-19

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408040
United States, Georgia | |
Northside Hospital | |
Atlanta, Georgia, United States, 30342 |
Principal Investigator: | Kent Holland, MD | Northside Hospital |
Responsible Party: | Northside Hospital, Inc. |
ClinicalTrials.gov Identifier: | NCT04408040 |
Other Study ID Numbers: |
NSH 1281 |
First Posted: | May 29, 2020 Key Record Dates |
Last Update Posted: | September 20, 2021 |
Last Verified: | September 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |