Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873414
Status:
UNKNOWN
Last Update Posted:
2021-06-02
First Post:
2021-04-26
Brief Title:
Convalescent Plasma as Adjunct Therapy for COVID-19
Sponsor:
National Institute of Health Research and Development Ministry of Health Republic of Indonesia
Organization:
National Institute of Health Research and Development Ministry of Health Republic of Indonesia
Study Overview
Official Title:
Clinical Trial of Convalescent Plasma Administration as Adjunct Therapy for COVID-19 Uji Klinik Pemberian Plasma Konvalesen Sebagai Terapi Tambahan COVID-19
Status:
UNKNOWN
Status Verified Date:
2021-05
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:
PlaSenTer
Brief Summary:
Convalescent plasma CP has been the subject of increasing expectation for treating coronavirus disease 2019 COVID-19 Reports on CP transfusion have shown promising clinical improvements without serious adverse events To date most studies focused on reporting CP treatment in patients with severe COVID-19 but only a few addressed benefits on less severe disease The vast majority of studies reporting COVID-19 infection and treatment have come from earlier affected countries with established health systems and research infrastructure while very few are from low- and middle-income countries LMICs Nonetheless CP therapy could be one of the few available options in LMICs where constraints may exist in the access to novel treatments even once available Clinical trials conducted in LMICs may differ in many respects from those in high-income countries
This study will evaluate the safety and efficacy of convalescent plasma therapy in hospitalized with moderate and severe COVID-19 to investigate the impacts of the treatment over the course of clinical illness including non-mortal clinical outcomes
This study will evaluate the safety and efficacy of convalescent plasma therapy in hospitalized with moderate and severe COVID-19 to investigate the impacts of the treatment over the course of clinical illness including non-mortal clinical outcomes
Detailed Description:
Coronavirus disease 2019 COVID-19 which is caused by severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 has spread rapidly around the world with high rates of transmission and substantial mortality
Convalescent plasma CP collected from recovered patients has been evaluated in the treatment of SARS Middle East respiratory syndrome MERS and Ebola but not well further studied and with no definitive results Preliminary studies in COVID-19 patients showed improvement in clinical status after CP transfusion However a multicenter open-label randomized clinical trial of 103 patients in China with severe or life-threatening COVID-19 found no statistical difference in clinical improvement within 28 days among patients treated with CP versus standard treatment alone
To date CP has not been approved as a standard of care for COVID-19 There are insufficient data from well-controlled adequately powered randomized clinical trials to evaluate the efficacy and safety of CP for the treatment of this disease One randomized controlled trial NCT04342182 was halted for redesign based on the consideration that most COVID-19 patients already have high neutralizing antibody titers at hospital admission and no difference in mortality p095 hospital stay p068 or day-15 disease severity p058 was observed between plasma treated patients and patients on standard of care Another clinical study NCT04345523 showed efficacy and safety of CP in preventing progression to severe disease or death However this study was halted early due to low enrolment Further studies have been published and assessed in several systematic reviews that remain uncertain about the safety and effectiveness of CP treatment for COVID-19
The vast majority of studies reporting COVID-19 trials have come from the earlier affected countries with established healthcare systems and better research infrastructure while very few are from low- and middle-income countries LMICs Meanwhile the cases in LMICs have risen considerably with critical research questions specific to the needs of are hard to answer As an LMIC with a geographically dispersed archipelago access to healthcare remains a challenge in remote districts that could impact the adoption of CP deployment in Indonesia Consequently clinical trials conducted in LMICs may differ in many respects from those in high-income countries
This study will evaluate the safety and efficacy of CP therapy in hospitalized with moderate and severe COVID-19 to investigate the impacts of the treatment over the course of clinical illness including non-mortal clinical outcomes This study will involve hospitals from different places of the Indonesian archipelago with different characteristics and community structures social and values To obtain supports for the trial the investigators will seek community engagement that allows investigators and community leaders working collaboratively
Convalescent plasma CP collected from recovered patients has been evaluated in the treatment of SARS Middle East respiratory syndrome MERS and Ebola but not well further studied and with no definitive results Preliminary studies in COVID-19 patients showed improvement in clinical status after CP transfusion However a multicenter open-label randomized clinical trial of 103 patients in China with severe or life-threatening COVID-19 found no statistical difference in clinical improvement within 28 days among patients treated with CP versus standard treatment alone
To date CP has not been approved as a standard of care for COVID-19 There are insufficient data from well-controlled adequately powered randomized clinical trials to evaluate the efficacy and safety of CP for the treatment of this disease One randomized controlled trial NCT04342182 was halted for redesign based on the consideration that most COVID-19 patients already have high neutralizing antibody titers at hospital admission and no difference in mortality p095 hospital stay p068 or day-15 disease severity p058 was observed between plasma treated patients and patients on standard of care Another clinical study NCT04345523 showed efficacy and safety of CP in preventing progression to severe disease or death However this study was halted early due to low enrolment Further studies have been published and assessed in several systematic reviews that remain uncertain about the safety and effectiveness of CP treatment for COVID-19
The vast majority of studies reporting COVID-19 trials have come from the earlier affected countries with established healthcare systems and better research infrastructure while very few are from low- and middle-income countries LMICs Meanwhile the cases in LMICs have risen considerably with critical research questions specific to the needs of are hard to answer As an LMIC with a geographically dispersed archipelago access to healthcare remains a challenge in remote districts that could impact the adoption of CP deployment in Indonesia Consequently clinical trials conducted in LMICs may differ in many respects from those in high-income countries
This study will evaluate the safety and efficacy of CP therapy in hospitalized with moderate and severe COVID-19 to investigate the impacts of the treatment over the course of clinical illness including non-mortal clinical outcomes This study will involve hospitals from different places of the Indonesian archipelago with different characteristics and community structures social and values To obtain supports for the trial the investigators will seek community engagement that allows investigators and community leaders working collaboratively
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