Convalescent plasma transfusion therapy in severe COVID-19 patients- a safety, efficacy and dose response study: A structured summary of a study protocol of a phase II randomized controlled trial (original) (raw)
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Open Access Macedonian Journal of Medical Sciences, 2021
BACKGROUND: Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by severe acute respiratory syndrome coronavirus 2. High mortality rate due to COVID-19 has become a serious health problem globally. At present, there is no definitive therapy for COVID-19. AIM: The objective of this study is to evaluate convalescent plasma therapy (CPT) in COVID-19 patients. METHODS: The study was conducted in prospective experimental design with sample population of COVID-19 inpatient in Dr. M. Djamil General Hospital, Padang, isolation ward. This study was involving 20 patients consisted of 10 patients of experimental group who received standard therapy and CPT and 10 patients of control group who received standard therapy only; 10 males and 10 females. Differences in laboratory results in both groups were analyzed by T-test or Mann–Whitney U-test. RESULTS: Twenty subjects included in this study with average of age 56.50 (9.606) years. The mean of C-reactive protein (CRP) serum of th...
Convalescent plasma transfusion for the treatment of COVID‐19: Systematic review
Journal of Medical Virology, 2020
Background The recent emergence of COVID-19 pandemic has reassessed the usefulness of historic convalescent plasma transfusion (CPT). This review was conducted to evaluate the effectiveness of CPT therapy in COVID-19 patients based on the publications reported till date. To our knowledge, this is the first systematic review on convalescent plasma on clinically relevant outcomes in individuals with COVID-19. Methods PubMed, EMBASE and Medline databases were searched upto 19 April 2020. All records were screened as per the protocol eligibility criteria. Results We included 5 studies reporting CPT to COVID-19 patients. The main findings from available data are as follows: (1) Convalescent plasma may reduce mortality in critically ill patients (2) Increase in neutralizing antibody titers and disappearance of SARS-CoV-2 RNA was observed in almost all the patients after CPT therapy (3) Beneficial effect on clinical symptoms after administration of convalescent plasma. Conclusions Based on the limited scientific data, CPT therapy in COVID-19 patient appears safe, clinically effective and reduces mortality. Well-designed large multi center clinical trial
einstein (São Paulo), 2024
Objective: This study compared the outcomes of two cohorts of patients with coronavirus disease 2019 (COVID-19) who received COVID-19 convalescent plasma transfusions between 2020 and 2021. Methods: This retrospective study was conducted at a tertiary hospital in São Paulo, Brazil. We included a retrospective cohort of patients who received convalescent compassionate plasma, and another group of patients from a previous clinical study. We collected clinical and laboratory data on the day of and 5 days after transfusion. Patients with hematological or immunological conditions were excluded. Statistical significance was set at p<0.05. Results: COVID-19 convalescent plasma did not affect the outcomes of patients with severe COVID-19 when comparing the two cohorts transfused with different volumes and titers of neutralizing antibodies. Despite improvements in some laboratory parameters, no effect on clinical outcomes was observed. Dialysis negatively affected the length of intensive care unit stay, hospitalization, and mechanical ventilation use. Each higher point on the day 0 World Health Organization scale reduced the probability of hospital and intensive care unit discharge and the risk of mechanical ventilation discontinuation. Conclusion: Dialysis and the assessed clinical severity represented by the World Health Organization scale on day 0 influenced the outcomes, whereas COVID-19 convalescent plasma transfusion did not.
Turkish Journal of Intensive Care
Objective: This study investigates the effect of convalescent plasma (CP) addition to the standard treatment on mortality in critical coronavirus disease-2019 (COVID-19) patients. Materials and Methods: This retrospective cohort study was conducted by evaluating the data of 255 critical COVID-19 patients in Marmara University Medical Faculty Hospital, Pandemic Intensive Care Unit (ICU), between April and November 2020. Results: The patients were divided into two groups, a control group that received standard treatment (153; 60.0%) versus a second group that received CP in addition to standard treatment (102; 40.0%). The ICU mortality rate was found to be lower (p<0.05) in patients receiving CP (38; 37.3%) compared to patients not receiving CP (79; 51.6%). The use of CP was found to reduce the probability of ICU mortality in patients with Acute Physiology and Chronic Health Evaluation-II (APACHE-II) score ≤10 [odds ratio (OR): 0.251; confidence interval (CI) 95%: 0.063-0.994, p=0.049) and APACHE-II score 11-14 (OR: 0.237; CI 95%: 0.066-0.844, p=0.026). CP transfusion, however, did not reduce the mortality in patients with an APACHE-II score of 15 and above. Furthermore, each day of delay in CP transfusion was found to increase the probability of mortality by 1.3 times (OR: 1.369; CI 95%: 1.155-1.622, p<0.001). Conclusion: The addition of CP to standard treatment in COVID-19 patients followed in ICU reduces mortality.
BMC Infectious Diseases
Background Convalescent plasma(CP) was utilized as potential therapy during COVID-19 pandemic in Pakistan. The study aimed at appraisal of CP transfusion safety and usefulness in COVID pneumonia. Methods Single arm, MEURI study design of non-randomized open label trial was conducted in five centers. Patients werecategorized as moderately severe, severe, and critical. The primary endpoint was a) improvement in clinical status and change in category of disease severity; secondary endpoint was b) CP ability to halt disease progression to invasive ventilation. CP transfused to hospitalized patients. Statistical tests including median (interquartile ranges), Mann-Whitney U test, Fisher’s exact test using SPSS ver. 23, ANOVA and Chi-square test were applied for the analysis of results parameters before and after CP treatment. SOFA score was applied for multiorgan failure in severe and critical cases. Results A total of 50 adult patients; median age 58.5 years (range: 29–92 years) received...
Experimental and Therapeutic Medicine, 2021
Therapeutic plasma exchange (TPE) has been proposed as a rescue therapy in critically ill COVID-19 patients. The aim of the present study was to determine whether combining TPE with convalescent plasma (CVP) transfusion early in the intensive care unit (ICU) stay improves survival among this heterogeneous population. The primary endpoint was survival at 30 days. Secondary endpoints included assessing the evolution of biomarkers, such as the partial pressure of arterial oxygen to fractional inspired oxygen ratio, and C reactive protein (CRP), lactate dehydrogenase (LDH) and ferritin levels at the 7-day follow-up. This single centre, prospective, non-randomized controlled trial was conducted in an 8-bed COVID-19 ICU and included patients with severe COVID-19 pneumonia requiring intensive care treatment. A total of 19 patients were treated by performing TPE followed by CVP transfusion, in addition to standard treatment, while for another 19 patients, only standard treatment according to hospital protocols was used. TPE was initiated during the first 24 h after ICU admission, followed immediately by transfusion of CVP. Survival at 30 days was 47.37% in the TPE CVP group and 26.32% in the control group (P=0.002). Patients in the TPE CVP group also showed better oxygenation and a reduction in inflammation, with decreased CRP, LDH and ferritin levels compared with those in the control group. Overall, the study indicated that early initiation of TPE followed by CVP transfusion may be a valid rescue therapy in severe and critically ill COVID-19 patients, with a statistically significant survival benefit, improved oxygenation and a reduction in inflammatory markers. The trial was registered in the ClinicalTrials.gov database (trial registration number: NCT04973488) on July 22, 2021 (retrospectively registered).
Vox Sanguinis, 2020
Background and objectives Use of convalescent plasma for coronavirus disease 2019 (COVID-19) treatment has gained interest worldwide. However, there is lack of evidence on its dosing, safety and effectiveness. Until data from clinical studies are available to provide solid evidence for worldwide applicable guidelines, there is a need to provide guidance to the transfusion community and researchers on this emergent therapeutic option. This paper aims to identify existing key gaps in current knowledge in the clinical application of COVID-19 convalescent plasma (CCP). Materials and methods The International Society of Blood Transfusion (ISBT) initiated a multidisciplinary working group with worldwide representation from all six continents with the aim of reviewing existing practices on CCP use from
Scientific Reports
Convalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p