Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 3:45 PM
Study NCT ID:
NCT04438694
Status:
UNKNOWN
Last Update Posted:
2020-09-29
First Post:
2020-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CP IN COVID19
Brief Summary:
* This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases.
* This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank.
The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection.
An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP).
Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).
* This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank.
The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection.
An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP).
Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).
Detailed Description:
This study will be done inside Cairo university hospitals, it will involve a number of CP donors who were recovered from COVID-19 infection and were treated at Cairo University isolation hospital. The CP donation process will take place at CUH blood bank ,the number of the donors will be determined at the end of the study as it will vary according to the donation process .
The study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo University isolation hospital.
The study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo University isolation hospital.
Study Oversight
Has Oversight DMC:
True
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?: