Efficacy and Safety of Convalescent Plasma Transfusion Administered as Adjunctive Treatment to Standard Treatment in Moderate, Severe, and/or Critically Ill Patients with COVID-19 in Dr. M. Djamil General Hospital (original) (raw)
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Trials
Objectives General: To assess the safety, efficacy and dose response of convalescent plasma (CP) transfusion in severe COVID-19 patients Specific: a. To identify the appropriate effective dose of CP therapy in severe patients b. To identify the efficacy of the therapy with their end point based on clinical improvement within seven days of treatment or until discharge whichever is later and in-hospital mortality c. To assess the clinical improvement after CP transfusion in severe COVID-19 patients d. To assess the laboratory improvement after CP transfusion in severe COVID-19 patients Trial Design This is a multicentre, multi-arm phase II Randomised Controlled Trial. Participants Age and sex matched COVID-19 positive (by RT-PCR) severe cases will be enrolled in this trial. Severe case is defined by the World Health Organization (W.H.O) clinical case definition. The inclusion criteria are 1. Respiratory rate > 30 breaths/min; PLUS 2. Severe respiratory distress; or SpO2 ≤ 88% on ro...
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...
Biomedical and Pharmacology Journal, 2021
Background: Coronavirus disease 2019 (COVID-19) was declared as a world pandemic since early 2020. There was no specific antiviral agent that appeared to be active against the virus, and antiviral agent such as remdesivir, favipiravir were in limited supply. We evaluated the use of convalescent plasma (CP) administered as adjuctive treatment to standard of care in moderate to severe COVID-19 patients. Methods: We conducted a series of 9 moderate to severe patients of COVID-19 older than 18 years received CP transfusion from 9 recovered donors at a single institution (Sulianti Saroso Infectious Disease Hospital, Jakarta, Indonesia) from January 2021 to June 2021. Results: Out of 9 patients (age range 30-81 years, 6 males and 3 female), and all patients received at least 1 or 2 unit of 200 mL of CP from 9 recovered donors. There were 4 patients (age range 30-71 years, 4 male) that were not treated with antiviral therapy. Of the 9 patients, 2 severe cases were died, while all of modera...
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.
Journal of Translational Medicine, 2021
Background Recently, convalescent plasma (CP) transfusion was employed for severe or critically ill patients with coronavirus disease-2019. However, the benefits of CP for patients with different conditions are still in debate. To contribute clinical evidence of CP on critically ill patients, we analyze the characteristics and outcomes of patients with or without CP transfusion. Methods In this cohort study, 14 patients received CP transfusion based on the standard treatments, whereas the other 10 patients received standard treatments as control. Clinical characteristics and outcomes were analyzed. The cumulative survival rate was calculated by Kaplan–Meier survival analysis. Results Data analysis was performed on 24 patients (male/female: 15/9) with a median age of 64.0 (44.5–74.5) years. Transient fever was reported in one patient. The cumulative mortality was 21% (3/14) in patients receiving CP transfusion during a 28-day observation, whereas one dead case (1/10) was reported in ...
Convalescent Plasma Therapy in Critically Ill COVID-19 Patients: An Open Label Trial
Oman Medical Journal, 2021
Introduction: Globally, the coronavirus disease 2019 (COVID-19) is still spreading rapidly. At present, there are no specifically approved therapeutic agents or vaccines for its treatment. Previous studies have shown that the convalescent plasma therapy (CPT) is effective in patients with COVID-19. However, its efficacy in patients with persistently positive nucleic acid test is unknown. Patient concerns: In this report, we present the clinical data of 5 critically ill COVID-19 patients admitted, between January 16 and February 26, 2020, in intensive care unit of Xiaogan Central Hospital. Diagnosis and interventions: All these patients had a persistently positive nucleic acid test and received CPT. All 5 patients had severe respiratory failure, and thus, required invasive mechanical ventilation. The median time from the onset of symptoms to initiating the CPT was 37 (Interquartile range, 34-44) days. Outcomes: Only 2 patients were cured and subsequently discharged, while 3 patients succumbed due to multiple organ failure. Conclusion: The time of initiating the CPT may be an important factor affecting its efficacy, and its therapeutic effect in the treatment of COVID-19, in the late stage, is limited. Abbreviations: COVID-19 = coronavirus disease 2019, CPT = convalescent plasma therapy, CRP = C-reactive protein, IQR = interquartile range, NAT = neutralizing antibody titer.
Journal of Infection in Developing Countries, 2023
Introduction: Covid Convalescent Plasma (CCP) failed to demonstrate its efficacy in severe and life-threatening coronavirus disease 2019 (COVID-19) cases. However, the role of CCP in hospitalized moderate cases is unclear. This study aims to examine the efficacy of administering CCP to hospitalized moderate coronavirus disease 2019 patients. Methodology: An open-label randomized controlled clinical trial design was used from November 2020-August 2021 at two referral hospitals in Jakarta, Indonesia, and the primary outcome was mortality at 14 days. The secondary outcomes were mortality at 28 days, the time-todiscontinuation of supplemental oxygen, and the time-to-hospital discharge. Results: This study recruited 44 subjects, and the intervention arm consisted of 21 respondents who received CCP. The control arm consisted of 23 subjects who received standard-of-care treatment. All subjects survived during the fourteen-day follow-up period, and the 28-day mortality rate in the intervention group was lower than the control (4.8% vs 13.0%; p = 0.16, HR = 4.39 (95% CI = 0.45-42.71). There was no statistically significant difference in the time-to-discontinuation of supplemental oxygen and time-to-hospital discharge. During the total follow-up period (41 days), the mortality rate in the intervention group was also lower than the control (4.8% vs 17.4%, p = 0.13, HR = 5.47, 95% CI = 0.60-49.55). Conclusions: This study concluded that in hospitalized moderate COVID-19 patients, CCP did not reduce 14-day mortality compared to the control. Mortality during 28 days and total length of stay (41 days) were lower in the CCP group compared to the control, although they did not reach statistical significance.
BackgroundConvalescent plasma (CP) therapy in COVID-19 disease has been suggested to improve clinical outcome in severe disease. This pilot study was designed to inform the design of a definitive phase 3 clinical trial.MethodsThis was a prospective, interventional and randomized open label pilot trial involving 40 patients with COVID-19 who were requiring oxygen therapy and who had radiological evidence of pneumonia. Twenty COVID-19 patients received two 200ml transfusions of convalescent patient CP over 24 hours were compared with 20 patients who received routine care alone. The primary outcome was the requirement for ventilation. The secondary outcomes were white blood cell count, lactate dehydrogenase (LDH), C-reactive protein (CRP), Troponin, Ferritin, D-Dimer, procalcitonin, mortality rate at 28 days.ResultsThe CP group were a higher risk group with higher ferritin levels (p<0.05) though respiratory indices did not differ. The primary outcome measure – ventilation – was requ...
F1000Research
Background: As an effective antiviral therapy is not available for the treatment of the current rapidly and continuously spreading coronavirus disease (COVID-19), it is very crucial to find an alternative treatment strategy. Convalescent plasma (CP) therapy has been used for prevention and treatment of many emerging infectious diseases, however, the results of current studies on CP in COVID-19 are not consistent. Therefore, this study aimed to evaluate the effectiveness of CP therapy in hospitalized patients with COVID-19, while evaluating patient and donor-related factors that might influence the therapeutic outcome. Methods: We conducted a retrospective cohort study on 312 patients with either severe or critical COVID-19, who were admitted to Al-Hakeem and Al-Amal hospitals in Al-Najaf city, Iraq from June to August 2020. The patients were allocated to either the plasma therapy group (152 patients) who received CP combined with standard therapy or the standard therapy group (160 ...
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