Clinical trial NCT04513158: Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
Official title: Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Keywords: SARS-CoV-2
Lead sponsor: Norton Healthcare
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All hospitalized patients meeting study inclusion/exclusion criteria and providing informed consent for participation in the study will receive one unit (approximately 200 mL) of convalescent plasma over one hour to with data collection of routine physical exams/clinical assessments (daily) and routine lab results (every 3 days).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Following the administration of one unit (approximately 200 mL) of convalescent plasma over one hour, the study proposes to determine the therapeutic efficacy (response rate) of convalescent plasma infusion in patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) by prevention of progression to severe or life threatening COVID-19 during the current hospitalization as determined by evaluating if the patient experienced the following the following: respiratory rate \>30/min, Blood oxygen saturation \<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300, or received a medical diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure. This will be captured from the daily physical exam/clinical assessment done as part of routine care and at discharge.

The study also proposes to determine the immunologic effects of convalescent plasma infusion as measured by serial SARS-CoV-2 Ag levels through RT-PCR measured by CoV PCR collected at enrollment, day 7 and discharge.

Finally, the study intends to measure normalization of laboratory parameters for risk which will be documented every 3 days while the patient is hospitalized until the time that lab value returns to within the institution's normal range.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Determine the Therapeutic Efficacy (Response Rate) of Convalescent Plasma Infusion in Patients at High Risk for Mortality When Infected by SARS-CoV-2 (COVID-19).
timeFrame: Through study completion, an average of 30 days
Secondary outcomes:
measure: Determine the Immunologic Effects of Convalescent Plasma Infusion
timeFrame: Through study completion, an average of 14 days
measure: Absolute Lymphocyte Count (10*3/uL)
timeFrame: Through study completion, an average of 14 days
measure: Reatinine Kinase (mg/dL)
timeFrame: Through study completion, an average of 14 days
measure: C-reactive Protein (mg/dl)
timeFrame: Through study completion, an average of 14 days
measure: D-Dimer (ng/ml FEU)
timeFrame: Through study completion, an average of 14 days
measure: Interleukin-6 (pg/ml)
timeFrame: Through study completion, an average of 14 days
measure: Ferritin (ng/mL)
timeFrame: Through study completion, an average of 14 days
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Women's and Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Audubon Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Brownsboro Hospital
state: Kentucky
Study officials:
affiliation: Norton Healthcare
name: Joseph M Flynn, DO, MPH
role: PRINCIPAL_INVESTIGATOR
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