Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04407208
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2020-05-16
Brief Title:
Convalescent Plasma Therapy in Patients With COVID-19
Sponsor:
Biofarma
Organization:
Biofarma
Study Overview
Official Title:
Convalescent Plasma Therapy in Patients With COVID-19
Status:
COMPLETED
Status Verified Date:
2020-06
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:
None
Brief Summary:
Scientists and medical workers all around the world were running out of time to manage COVID-19 Several studies have been done to understand the disease and ultimately to find possible treatment Based on those studies one of the potential treatment was antibody transfer from recovered COVID-19 patients Passive antibody transfer was a fast and easy choice The rational use of antibody from the patients plasma is a natural neutralizing protein to the cell-infected virus and could possibly slow the active infection down Investigators initiate an intervention study with purposes to produce quality convalescent plasma from the recovered patients define the safety of plasma for human use and as an alternative treatment to improve the clinical outcomes of severe COVID-19 patients
The study hypothesis is convalescent plasma is safe and could possibly improve outcome of severe non-critical COVID-19 patients This research will conduct the plaque reduction neutralizing test PRNT of recipient blood in vitro The plasma will be collected in the blood transfusion unit BTU in Gatot Soebroto hospital The storage testing transfer and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU PRNT and plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of Molecular Biology
Investigators enroll approximately 10 patients consecutively who will be admitted at Gatot Soebroto hospital Baseline demographic characteristics of samples are recorded Clinical dan laboratory data will be measured before and after plasma transfusion periodically The measured variables are pharmacological therapy antivirus antibiotics steroids invasive oxygen therapy oxygen index sequential organ failure assessment SOFA score and laboratory parameters such as leukocyte count blood chemical panel include liver and renal function C-reactive protein procalcitonin IL-6 and immunoglobulin titer of the recipient and also chest X-ray evaluation
The potential expected risk of plasma transfusions is transfusion reaction immunological or non-immune related and transferred foreign pathogen Investigator will report and treat all adverse events after plasma transfusion has been done A severe adverse event SAE will also report in a special form to sponsor and data safety monitoring board DSMB There is theoretically antibody-dependent enhancement ADE mechanism from COVID-19 whom will receive plasma transfusion to progress to severe immune response
This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future
The study hypothesis is convalescent plasma is safe and could possibly improve outcome of severe non-critical COVID-19 patients This research will conduct the plaque reduction neutralizing test PRNT of recipient blood in vitro The plasma will be collected in the blood transfusion unit BTU in Gatot Soebroto hospital The storage testing transfer and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU PRNT and plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of Molecular Biology
Investigators enroll approximately 10 patients consecutively who will be admitted at Gatot Soebroto hospital Baseline demographic characteristics of samples are recorded Clinical dan laboratory data will be measured before and after plasma transfusion periodically The measured variables are pharmacological therapy antivirus antibiotics steroids invasive oxygen therapy oxygen index sequential organ failure assessment SOFA score and laboratory parameters such as leukocyte count blood chemical panel include liver and renal function C-reactive protein procalcitonin IL-6 and immunoglobulin titer of the recipient and also chest X-ray evaluation
The potential expected risk of plasma transfusions is transfusion reaction immunological or non-immune related and transferred foreign pathogen Investigator will report and treat all adverse events after plasma transfusion has been done A severe adverse event SAE will also report in a special form to sponsor and data safety monitoring board DSMB There is theoretically antibody-dependent enhancement ADE mechanism from COVID-19 whom will receive plasma transfusion to progress to severe immune response
This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future
Detailed Description:
The rational use of antibodies from the recovered patients plasma as a natural neutralizing antibody to the cell-infected virus plaques Several expanded use of convalescent plasma therapy to severe andor critically ill COVID-19 patients had been done in the US and China Investigator reported that 5 patients received convalescent plasma three patients were successfully discharged and 2 patients improved
Based on the previous study investigators initiate an intervention study with purposes to produce quality convalescent plasma from the recovered patients and to find an alternative treatment to improve the clinical outcomes of severe COVID-19 patients
Investigators research questions are
1 Are the convalescent plasma could neutralize cell-infected virus in vitro
2 Are those COVID-19 patients who received convalescent plasma will have a better prognosis and possibly be cured The Investigator study hypothesis is convalescent plasma could possibly cure severe non-critical COVID-19 patients
The primary objective of this study is to produce a good quality convalescent plasma from recovered COVID-19 patient which could neutralize the plaque in vitro and in Vivo In Vivo neutralization will be monitored based on the patients clinical improvement of symptoms laboratory and radiology assessment
Invitro tests will be done to the recipient plasma before and after convalescent plasma transfusion The objective evaluation will be a plaque reduction neutralizing test PRNT of recipient plasma Donor plasma will be collected by apheresis methods at the Gatot Soebroto Blood transfusion unit BTU
All donors must meet the eligibility criteria and sign an informed consent form Donors plasma will be screened for blood-borne infection pathogens in BTU Each donor will produce 210 ml of plasma which 200 ml will be stored in 2 separate bags each 100 ml and 3 ml of plasma will be tested for antibody anti-COVID-19 titer in Biofarma and 3 ml of plasma will be tested for PRNT in Eijkman Institute Plasma transfusion will be given to COVID-19 patients with severe IIb and critical conditions The storage testing transfer and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU Investigators enroll approximately 10 patients consecutively who will be admitted at Gatot Soebroto hospital
All recipients will be enrolled consecutively if they met the eligibility criteria Baseline demographic characteristics of the included patient are recorded in case report forms Clinical and laboratory data will be measured before the plasma transfusion Pre-transfusion patients will be put in group 1 Whereas group 2 is the same patient but received the convalescent plasma
Transfusions will be given twice in 100 ml bag during the 1st 4 hours the acute adverse event will be monitored There will be three serial transfusions on the 1st day 3rd day and 6th day The clinical laboratory and radiology parameters will be re-measured after the14th day and they will be analyzed
Data analysis will be done after all the measurement is finished and recorded in clinical report form Investigators will find the mean difference of ordinal variables between group 1 and group two with the Wilcoxon signed-rank test alternative to the paired T-test The relative risk risk reduction of nominal variables will be measured between group 1 and group 2 Unfortunately it is impossible to determine the number needed to harm NNH in this research since both groups are depending on each other
All documents regarding the study will be kept in data form and will be protected with a password We will concern about the safety of convalescent plasma by recording all adverse events after transfusion To anticipate the risk of AE progression to a severe adverse event SAE all of the AE will be treated as soon as it is found according to the clinical competence of treating physicians SAE will be reported in a certain form to sponsor and data safety monitoring board as soon as possible
Investigators are all aware of the potential ethical issue regarding this study The plasma convalescent is an alternative therapy for COVID-19 and urgently needed because of the pandemic situation currently happen Investigators are weighing all potential expected and theoretical risks and benefits of convalescent plasma transfusion The potential expected risk of plasma transfusions is transfusion reaction immunological or non-immune related and transferred unwanted pathogen The theoretical risk from plasma transfusion of COVID-19 patient is an antibody-dependent enhancement ADE mechanism as seen in dengue patients A Potential benefit of plasma for the patient is the neutralizing potential of a polyclonal antibody to cell infected SARS-Cov2 Resulting in faster recovery and improvement of the disease stages
All donors will read the informed consent form thoroughly and willingly given their plasma draw at Gatot Soebroto BTU The donor could revoke hisher consent at any time before being transfused even after the plasma has been processed and stored in BTU Donors decision will not affect hisher future treatment at Gatot Soebroto hospital
This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future
Based on the previous study investigators initiate an intervention study with purposes to produce quality convalescent plasma from the recovered patients and to find an alternative treatment to improve the clinical outcomes of severe COVID-19 patients
Investigators research questions are
1 Are the convalescent plasma could neutralize cell-infected virus in vitro
2 Are those COVID-19 patients who received convalescent plasma will have a better prognosis and possibly be cured The Investigator study hypothesis is convalescent plasma could possibly cure severe non-critical COVID-19 patients
The primary objective of this study is to produce a good quality convalescent plasma from recovered COVID-19 patient which could neutralize the plaque in vitro and in Vivo In Vivo neutralization will be monitored based on the patients clinical improvement of symptoms laboratory and radiology assessment
Invitro tests will be done to the recipient plasma before and after convalescent plasma transfusion The objective evaluation will be a plaque reduction neutralizing test PRNT of recipient plasma Donor plasma will be collected by apheresis methods at the Gatot Soebroto Blood transfusion unit BTU
All donors must meet the eligibility criteria and sign an informed consent form Donors plasma will be screened for blood-borne infection pathogens in BTU Each donor will produce 210 ml of plasma which 200 ml will be stored in 2 separate bags each 100 ml and 3 ml of plasma will be tested for antibody anti-COVID-19 titer in Biofarma and 3 ml of plasma will be tested for PRNT in Eijkman Institute Plasma transfusion will be given to COVID-19 patients with severe IIb and critical conditions The storage testing transfer and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU Investigators enroll approximately 10 patients consecutively who will be admitted at Gatot Soebroto hospital
All recipients will be enrolled consecutively if they met the eligibility criteria Baseline demographic characteristics of the included patient are recorded in case report forms Clinical and laboratory data will be measured before the plasma transfusion Pre-transfusion patients will be put in group 1 Whereas group 2 is the same patient but received the convalescent plasma
Transfusions will be given twice in 100 ml bag during the 1st 4 hours the acute adverse event will be monitored There will be three serial transfusions on the 1st day 3rd day and 6th day The clinical laboratory and radiology parameters will be re-measured after the14th day and they will be analyzed
Data analysis will be done after all the measurement is finished and recorded in clinical report form Investigators will find the mean difference of ordinal variables between group 1 and group two with the Wilcoxon signed-rank test alternative to the paired T-test The relative risk risk reduction of nominal variables will be measured between group 1 and group 2 Unfortunately it is impossible to determine the number needed to harm NNH in this research since both groups are depending on each other
All documents regarding the study will be kept in data form and will be protected with a password We will concern about the safety of convalescent plasma by recording all adverse events after transfusion To anticipate the risk of AE progression to a severe adverse event SAE all of the AE will be treated as soon as it is found according to the clinical competence of treating physicians SAE will be reported in a certain form to sponsor and data safety monitoring board as soon as possible
Investigators are all aware of the potential ethical issue regarding this study The plasma convalescent is an alternative therapy for COVID-19 and urgently needed because of the pandemic situation currently happen Investigators are weighing all potential expected and theoretical risks and benefits of convalescent plasma transfusion The potential expected risk of plasma transfusions is transfusion reaction immunological or non-immune related and transferred unwanted pathogen The theoretical risk from plasma transfusion of COVID-19 patient is an antibody-dependent enhancement ADE mechanism as seen in dengue patients A Potential benefit of plasma for the patient is the neutralizing potential of a polyclonal antibody to cell infected SARS-Cov2 Resulting in faster recovery and improvement of the disease stages
All donors will read the informed consent form thoroughly and willingly given their plasma draw at Gatot Soebroto BTU The donor could revoke hisher consent at any time before being transfused even after the plasma has been processed and stored in BTU Donors decision will not affect hisher future treatment at Gatot Soebroto hospital
This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future
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?:
False
Is an FDA AA801 Violation?:
None