Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513158
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
2020-08-06
Brief Title:
Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 COVID-19 Infection
Sponsor:
Joseph M Flynn DO MPH
Organization:
Norton Healthcare
Study Overview
Official Title:
Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 COVID-19 Infection
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Newly reported data at the time indicated that alternative therapies were more effective than CP for early treatment of high-risk patients with COVID-19
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 examclinical 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 30min 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 dysfunctionfailure This will be captured from the daily physical examclinical 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 institutions normal range
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 institutions normal range
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None