Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590207
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Convalescent Plasma for the Treatment of Patients with WNV - a Double- Blind Randomized Controlled Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Administering Convalescent Plasma Rich with Neutralizing Abs to Hospitalized Adults with WNV - a Double-blind Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Name of the study
Administering neutralizing convalescent plasma to hospitalized patients with West Nile fever - a double-blind randomized controlled study
The purpose of this study is to test the safety and effectiveness of giving blood plasma from convalescents rich in neutralizers as treatment against West Nile fever
Administering neutralizing convalescent plasma to hospitalized patients with West Nile fever - a double-blind randomized controlled study
The purpose of this study is to test the safety and effectiveness of giving blood plasma from convalescents rich in neutralizers as treatment against West Nile fever
Detailed Description:
The study is performed in Sheba Medical Center and will be expanded in the soon future to other Medical centers in Israel
Hospitalized patients diagnosed by bloodCSF PCR or IgM with West Nile Virus will be recruited to the study
After signing an informed consent they will be randomized 21 to receive either blood plasma rich in neutralizing antibodies or saline as placebo
Number of participants in this center 130 Age range 60 years old and older 18-60 years old with immunosuppression
Inclusion criteria
Hospitalized patients with positive WNV-PCR with feverneurological symptoms and 72 hours have not yet passed since the positive result
Age 60 or older
Age over 18 and younger than 60 with immunosuppression hypogammaglobulinemia solid organ transplants bone marrow transplants hemato-oncological malignancies
Exclusion criteria
Age younger than 60 without immunosuppression
More than 72 hours have passed since the diagnosis of West Nile fever
Pregnant women
Reference to the inclusion of pregnant women special populations - children and those lacking judgment- not relevant excludes pregnant women and special populations
The duration of the medical trial includes the follow-up period after the trial
The duration of the treatment is one day single dose of plasmasaline The follow-up period is 90 days
The clinical follow-up plan during and at the end of the treatment
A total of 10 visits will be conducted On day 1 the following will be performed screening Medical history Physical examination IV Convalescent Plasma vs Saline Urine and blood for PCR functional neurologic assesment IgG and IgM from serum blood test for CBC renal function
On day 2-7 and 30 and 90 AE will be collected On day 3 5 7 Urine and blood for PCR will be collected Neurologic assesment will be conducted on all visits Serology will be collected also on day 30 and 90
After discharge a follow-up visit will be performed either by a visit to the clinic or via phone call
Hospitalized patients diagnosed by bloodCSF PCR or IgM with West Nile Virus will be recruited to the study
After signing an informed consent they will be randomized 21 to receive either blood plasma rich in neutralizing antibodies or saline as placebo
Number of participants in this center 130 Age range 60 years old and older 18-60 years old with immunosuppression
Inclusion criteria
Hospitalized patients with positive WNV-PCR with feverneurological symptoms and 72 hours have not yet passed since the positive result
Age 60 or older
Age over 18 and younger than 60 with immunosuppression hypogammaglobulinemia solid organ transplants bone marrow transplants hemato-oncological malignancies
Exclusion criteria
Age younger than 60 without immunosuppression
More than 72 hours have passed since the diagnosis of West Nile fever
Pregnant women
Reference to the inclusion of pregnant women special populations - children and those lacking judgment- not relevant excludes pregnant women and special populations
The duration of the medical trial includes the follow-up period after the trial
The duration of the treatment is one day single dose of plasmasaline The follow-up period is 90 days
The clinical follow-up plan during and at the end of the treatment
A total of 10 visits will be conducted On day 1 the following will be performed screening Medical history Physical examination IV Convalescent Plasma vs Saline Urine and blood for PCR functional neurologic assesment IgG and IgM from serum blood test for CBC renal function
On day 2-7 and 30 and 90 AE will be collected On day 3 5 7 Urine and blood for PCR will be collected Neurologic assesment will be conducted on all visits Serology will be collected also on day 30 and 90
After discharge a follow-up visit will be performed either by a visit to the clinic or via phone call
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None