Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04445207 |
Expanded Access Status :
Available
First Posted : June 24, 2020
Last Update Posted : March 8, 2022
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Condition or disease | Intervention/treatment |
---|---|
COVID Sars-CoV2 Corona Virus Infection | Biological: Convalescent Plasma |
Study Type : | Expanded Access |
Expanded Access Type : | Treatment IND/Protocol |
Official Title: | Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19 |

- Biological: Convalescent Plasma
One to two 200 mL units of Convalescent plasma per infusion, up to 6 total units within a 3-week period.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
- At least 12 years of age
- Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status)
- Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease.
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Severe COVID-19 is defined by one or more of the following:
- Dyspnea
- Respiratory frequency ≥ 30/min
- Blood oxygen saturation ≤ 93%
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
- Lung infiltrates > 50% within 24-48 hours
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Life-threatening COVID-19 is defined as one or more of the following:
- Respiratory failure
- Septic shock
- Multiple organ dysfunction or failure
Exclusion Criteria:
- History of prior life-threatening reactions to transfusion of blood products
- Not receiving other therapies that would preclude plasma transfusion

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): NCT04445207
Contact: Jonathan Gerber, MD | 508-856-3216 | cancerresearch@umassmed.edu | |
Contact: Cara Gregoire | 774-455-4458 | Cara.Gregoire@umassmed.edu |
United States, Massachusetts | |
UMass Medical School | Available |
Worcester, Massachusetts, United States, 01655 | |
Contact: Principal Investigator |
Principal Investigator: | Jonathan Gerber, MD | UMASS MEDICAL SCHOOL |
Responsible Party: | Jonathan Gerber, Associate Professor, University of Massachusetts, Worcester |
ClinicalTrials.gov Identifier: | NCT04445207 |
Other Study ID Numbers: |
H000020420 |
First Posted: | June 24, 2020 Key Record Dates |
Last Update Posted: | March 8, 2022 |
Last Verified: | March 2022 |
COVID-19 Coronavirus Sars-CoV2 |
COVID-19 Coronavirus Infections Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia |
Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |