Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection

Covid19 Clinical Trial

Official title:

Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04513158
• Other study ID #: 20-N0124
• Status: Recruiting
• Phase: Phase 2
• Start date: August 14, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: Norton Healthcare
• Contact: Joseph M Flynn, DO, MPH
• Phone: 502-272-5001
• Email: Joseph.flynn[@]nortonhealthcare.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Infection

Intervention

Biological:
• Convalescent Plasma
Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.

Locations

Country	Name	City	State
United States	Norton Audubon Hospital	Louisville	Kentucky
United States	Norton Brownsboro Hospital	Louisville	Kentucky
United States	Norton Hospital	Louisville	Kentucky
United States	Norton Women's and Children's Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Joseph M. Flynn, D.O., MPH

Country where clinical trial is conducted

United States, 

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Measured by respiratory rate >30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration <300 and received a medical diagnosis of respiratory failure, septic shock or multiple	Through study completion, an average of 30 days
Secondary	Determine the immunologic effects of convalescent plasma infusion	SARS-CoV-2 Ag levels through RT-PCR	Through study completion, an average of 14 days
Secondary	Absolute lymphocyte count (10*3/uL)	Measure normalization of laboratory parameters for risk	Through study completion, an average of 14 days
Secondary	reatinine kinase (mg/dL)	Measure normalization of laboratory parameters for risk	Through study completion, an average of 14 days
Secondary	C-reactive protein (mg/dl)	Measure normalization of laboratory parameters for risk	Through study completion, an average of 14 days
Secondary	D-Dimer (ng/ml FEU)	Measure normalization of laboratory parameters for risk	Through study completion, an average of 14 days
Secondary	Interleukin-6 (pg/ml)	Measure normalization of laboratory parameters for risk	Through study completion, an average of 14 days
Secondary	Ferritin (ng/mL)	Measure normalization of laboratory parameters for risk	Through study completion, an average of 14 days