Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04333355
Status:
TERMINATED
Last Update Posted:
2021-02-10
First Post:
2020-03-31
Brief Title:
Safety in Convalescent Plasma Transfusion to COVID-19
Sponsor:
Hospital San Jose Tec de Monterrey
Organization:
Hospital San Jose Tec de Monterrey
Study Overview
Official Title:
Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Other clinical trails probed that the use of convalescent plasma for patients with COVID-19 is safe
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19 Different therapies are still under investigation and are use in different health institutions however a significant proportion of patients do not respond to these treatments so it is important to seek new treatments One of these alternatives is the use of convalescent plasma The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease This plasma will be infused in patients affected by the same virus but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine hydroxychloroquine azithromycin and other antivirals The investigator will evaluate the safety of this procedure by accounting for any adverse event
Detailed Description:
There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19 Different therapies are still under investigation and are use in different health institutions however a significant proportion of patients do not respond to these treatments so it is important to seek new treatments One of these alternatives is the use of convalescent plasma
The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease Donors will be screened for infectious diseases including sARS-CoV-2 and will be programmed for apheresis the next day The investigaotr will process one plasmatic volume per donor and this will be guarded in the blood bank until required by the principal investigator
Patients or receptors will be screened and selected by the research team according to eligibility criteria including severe disease refractory to treatment such as chloroquine hydroxychloroquine azithromycin and other antivirals Plasma will be fractioned in 250ml Infusion will start after a clinical evaluation and blood sampling Patients will remain under careful observation If no adverse event is present infusion will be repeated after 24 hours and the investigator will evaluate patients again 48 hours after the second transfusion A final evaluation will be performed at day 14 The investigator will evaluate the safety of this procedure by accounting for any adverse event
The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease Donors will be screened for infectious diseases including sARS-CoV-2 and will be programmed for apheresis the next day The investigaotr will process one plasmatic volume per donor and this will be guarded in the blood bank until required by the principal investigator
Patients or receptors will be screened and selected by the research team according to eligibility criteria including severe disease refractory to treatment such as chloroquine hydroxychloroquine azithromycin and other antivirals Plasma will be fractioned in 250ml Infusion will start after a clinical evaluation and blood sampling Patients will remain under careful observation If no adverse event is present infusion will be repeated after 24 hours and the investigator will evaluate patients again 48 hours after the second transfusion A final evaluation will be performed at day 14 The investigator will evaluate the safety of this procedure by accounting for any adverse event
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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