Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04547660
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2020-09-09
Brief Title:
Convalescent Plasma for Severe COVID-19 Patients
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Convalescent Plasma for Severe COVID-19 Patients a Randomized Open-label Phase 3 Trial
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
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:
PLACOVID
Brief Summary:
Plasma the supernatant part of blood contains a variety of different proteins including immunoglobulins These proteins also called antibodies are directed to previous foreign infecting organisms such as virus bacteria or parasites Patients recovering from SARS-Cov-2 infection may develop protective antibodies which can prevent reinfection with the same agent or similar organisms with shared molecular structures Those antibodies may be transferred to other patients through collection of such convalescent plasma from recovered donors and its transfusion to ill patients In this research the primary hypothesis is that those antibodies can exert passive immunization and help ameliorate symptoms from COVID-19 Coronavirus Disease 2019 resulting in higher clinical improvement rates at day 28 especially when administered early in the infection course
Detailed Description:
This is a randomized open-label phase 3 clinical trial on the use of convalescent plasma for severe COVID-19 patients In this research we are going to assess efficacy and safety of convalescent plasma in the treatment of severely compromised COVID-19 patients Convalescent plasma will be collected from recovered COVID-19 patients who will be recruited as plasma donors and will be submitted to apheresis with minimum interval of 14 days to obtain two aliquots of 300 ml of convalescent plasma which will be frozen at -80 and stored at -20 to -30 degrees Celsius Enrolled patients will be randomized based on a concealed sequential allocation list by an independent researcher which will not be aware of patients characteristics and stratified by COVID-19 severity severe or life-threatening There will be two arms of study intervention or control group and patients will be followed up for the next 28 days for clinical and laboratory outcomes such as improvement of disease status measured by a 6-point ordinal severity scale mechanical ventilation intensive care unit ICU and total hospital stay period cytokine levels IL-6 and TNF-alfa and several inflammatory cellular injury and coagulation parameters Intervention was conceived as two infusions of 300 ml of convalescent plasma 2 days apart Control group will receive full supportive treatment but will not be allowed to receive other investigational drugs Sample size was calculated to a total of 160 patients with a 11 randomization proportion between groups This amount would be capable to detect an 18 or higher difference in the proportion of clinical improvement at 28 days of enrollment between intervention and control groups with an alfa error of 005 and a statistical power of 08
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