Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
Stopped early · Phase 2
Conditions studied: Covid19
In brief
This study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.
Key facts
- Study ID
- NCT04513158
- Run by
- Joseph M. Flynn, D.O., MPH
- People needed
- 2
- Starts
- 2020-08-14
- Expected to finish
- 2021-04-28
- Last updated by the study team
- 2024-10-24
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of SARS-CoV-2 infection via RT-PCR or FDA approved testing.
- Patients must also have the following indications for enrollment:
- i. D-Dimer > 500 ng/ml FEU OR
- ii. IL-6> 5 pg/mL
- With any of the following:
- iii. Lymphocytes < 0.8 103/ul OR
- iv. LDH > 700 U/L OR
- v. CK > 170 U/L OR
- vi. CRP > 1.0 mg/dl OR
- vii. Ferritin > 1000 ng/ml
- AND one of the following:
- viii. Age over 60 years
- ix. Underlying Active Malignancy
- x. Cardiovascular Disease
- xi. Active Tobacco Use
- xii. History of Pulmonary Volume Reduction Surgery
- xiii. Hypertension
- Prior Treatment: Patients are still eligible for this trial if active antimicrobial agents are in use. Patients are also eligible if they had been treated on COVID-19 clinical trial in the course of their disease.
- Age ≥ 18 years.
- The effects of allogeneic plasma infusion on the developing fetus is unknown. For this reason women who are pregnant are not eligible to participate.
- Agrees to required laboratory data collected which will include the baseline organ function and regular ongoing assessments done as part of routine care.
- Ability to understand and the willingness to sign a written informed consent document or ability to have consent provided by Legally Authorized Representative.
You may not qualify if…
- 4.2.1 Patients who do not meet above inclusion criteria are not eligible.
- 4.2.2 Patients may not be receiving any other investigational agents.
- 4.2.3 History of allergic reactions attributed to previous transfusion history.
- 4.2.4 Respiratory rate >30/min
- 4.2.5 Blood oxygen saturation <93%
- 4.2.6 Partial pressure of arterial oxygen to fraction of inspired oxygen ration <300
- 4.2.7 Diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure
Where it is running
- Norton Hospital — Louisville, Kentucky, United States
- Norton Women's and Children's Hospital — Louisville, Kentucky, United States
- Norton Audubon Hospital — Louisville, Kentucky, United States
- Norton Brownsboro Hospital — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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