Abstract

INTRODUCTION The treatment of COVID-19 is still challenge. So convalescent plasma can be an important alternative of treatment. Protocols with nursing care during infusion is very important to guide an effective and safety care. OBJECTIVE to analyze the evidence in the literature on the action of convalescent plasma, of the use of protocols with nursing care to use convalescent plasma and build a nursing care protocol for transfusion in patients with COVID-19. METHODS Methodological study carried out in two stages: scoping review. The search was done using the descriptors: convalescent plasma transfusion, convalescent plasma, and acute respiratory syndromes or COVID-19, to found protocols and effectiveness of convalescent plasm. Beside was done a specialist panel to build the protocol. RESULTS Low-evidence studies have shown improvement in the clinical signs of COVID-19 using Convalescent Plasma, reduction or elimination of viral load, benefits in the production of lymphocytes, decreases C-reactive protein, increases titers of anti-SARS-CoV-2 antibodies, positive evolution in lung involvement identified by X-rays, decrease in hospitalization. No studies were found in the databases on the protocol for clinical nursing care in plasma transfusion. Therefore, a protocol was developed with the description of clinical nursing care to be performed before, during and after the transfusion by plasma: checking of vital signs and indicative signs of transfusion reaction, measurement of oxygen saturation, assessment of venous access and checking of the level of consciousness. CONCLUSION There are no evidence studies to support the use of plasma, nor anything related to bundles.

Abstract

AIM: This study aims to analyze the effectiveness of convalescent plasma therapy in children who are confirmed positive for coronavirus disease-2019. This study focuses on the mechanism of treatment administration and the prognosis after convalescent plasma transfusion. METHOD Article searches were conducted using a combination of keywords, namely, "COVID-19," "convalescent plasma," and "children" or "pediatric." Databases used were from Pubmed, ScienceDirect, Wiley Online, Springerlink, and Ebsco and 501 articles were found. The articles submitted are articles with low bias, where the selection of reports follows the inclusion and exclusion criteria according to the Preferred Reporting Items for Systematic Review and Meta-Analysis protocol. RESULTS A total of 8 articles were selected. Convalescent plasma transfusion was given to 11 children whose condition worsened starting with signs of tachypnea and decreased saturation, then the children were admitted to intensive care. The dose of convalescent plasma is based on the child's weight. All children had a good prognosis after the transfusion, and 7 children had recovered and were discharged from the hospital. CONCLUSION Convalescent plasma transfusion in children who are confirmed positive for coronavirus disease-2019 effectively improves the clinical condition of children. However, it must be noted that the blood from the donor has gone through the correct protocol.

Abstract

OBJECTIVE Evaluate the safety and effectiveness of convalescent plasma (CP) or hyperimmune immunoglobulin (hIVIG) in severe respiratory disease caused by coronaviruses or influenza, in patients of all ages requiring hospital admission. METHODS We searched multiple electronic databases for all publications to 12th October 2020, and RCTs only to 28th June 2021. Two reviewers screened, extracted, and analysed data. We used Cochrane ROB (Risk of Bias)1 for RCTs, ROBINS-I for non-RCTs, and GRADE to assess the certainty of the evidence. RESULTS Data from 30 RCTs and 2 non-RCTs showed no overall difference between groups for all-cause mortality and adverse events in four comparisons. Certainty of the evidence was downgraded for high ROB and imprecision. (1) CP versus standard care (SoC) (20 RCTS, 2 non-RCTs, very-low to moderate-high certainty); (2) CP versus biologically active control (6 RCTs, very-low certainty); (3) hIVIG versus SoC (3 RCTs, very-low certainty); (4) early CP versus deferred CP (1 RCT, very-low certainty). Subgrouping by titre improved precision in one outcome (30-day mortality) for the 'COVID high-titre' category in Comparison 1 (no difference, high certainty) and Comparison 2 (favours CP, very-low certainty). Post hoc analysis suggests a possible benefit of CP in patients testing negative for antibodies at baseline, compared with those testing positive. CONCLUSION A minimum titre should be established and ensured for a positive biological response to the therapy. Further research on the impact of CP/hIVIG in patients who have not yet produced antibodies to the virus would be useful to target therapies at groups who will potentially benefit the most.

Abstract

BACKGROUND When the SARS-CoV-2 pandemic began, no uniform treatment and care strategies for critically ill COVID-19 patients were yet available. National and international treatment recommendations were formulated under time pressure, initially on the basis of indirect evidence from the treatment of similar diseases. In this article, we give an overview of the content, currency, and methodological quality of the existing national and international guidelines, with special attention to the care of critically ill patients. METHODS Guidelines were identified by a comprehensive search, the included guidelines were assessed in standardized fashion with the AGREE II guideline assessment instrument and according to the AMWF rulebook criteria, and the core recommendations of the included and methodologically high-quality guidelines were compared. RESULTS Nine of the 97 guidelines that were identified fulfilled the content criteria for inclusion, and 6 of these fulfilled the qualitative criteria; these 6 guidelines still differed, however, in the topics to which they devoted the most attention, as well as in their methodological quality and currency. The treatment strategies for patients with severe respiratory failure (lung-protective ventilation strategies and rescue measures) deviated little from established standards. Uniform recommendations were made, among other things, for the administration of dexamethasone, which was recommended in all of the guidelines for patients requiring oxygen treatment, as well as for antithrombotic drug prophylaxis and for the prone positioning of ventilated patients. Many recommendations were based on insufficient evidence, and some were contradictory, e.g., those regarding antibiotic treatment or the choice between high-flow oxygen administration via nasal canula (HFNC) and noninvasive ventilation (NIV). CONCLUSION The consultation of multiple high-quality international guidelines and guideline recommendations shared in online portals such as MagicApp are helpful sources of information for clinicians. In view of the continuing lack of strong evidence, further research on intensive care treatments is needed (aspects of ventilation, positioning therapy, and the role of extracorporeal membrane oxygenation [ECMO]).

Abstract

Patients with cancer are at high risk of severe coronavirus disease 2019 (COVID-19), with high morbidity and mortality. Furthermore, impaired humoral response renders severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines less effective and treatment options are scarce. Randomized trials using convalescent plasma are missing for high-risk patients. Here, we performed a randomized, open-label, multicenter trial ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE ) in hospitalized patients with severe COVID-19 (n = 134) within four risk groups ((1) cancer (n = 56); (2) immunosuppression (n = 16); (3) laboratory-based risk factors (n = 36); and (4) advanced age (n = 26)) randomized to standard of care (control arm) or standard of care plus convalescent/vaccinated anti-SARS-CoV-2 plasma (plasma arm). No serious adverse events were observed related to the plasma treatment. Clinical improvement as the primary outcome was assessed using a seven-point ordinal scale. Secondary outcomes were time to discharge and overall survival. For the four groups combined, those receiving plasma did not improve clinically compared with those in the control arm (hazard ratio (HR) = 1.29; P = 0.205). However, patients with cancer experienced a shortened median time to improvement (HR = 2.50; P = 0.003) and superior survival with plasma treatment versus the control arm (HR = 0.28; P = 0.042). Neutralizing antibody activity increased in the plasma cohort but not in the control cohort of patients with cancer (P = 0.001). Taken together, convalescent/vaccinated plasma may improve COVID-19 outcomes in patients with cancer who are unable to intrinsically generate an adequate immune response.

Abstract

OBJECTIVE To assess clinical and immunological benefits of passive immunization using convalescent plasma therapy (CPT) we performed sub-group analyses on a completed randomised control trial (RCT) on CPT in severe COVID-19. PATIENTS A series of subclass analyses were performed on the previously published outcome data and accompanying clinical metadata from a completed RCT (Clinical Trial Registry of India, No. CTRI/2020/05/025209). METHODS The subclass analyses were performed on the outcome data and accompanying clinical metadata from a completed randomized control trial. Data on the plasma abundance of a large panel of cytokines from the same cohort of patients were also utilised to characterize the heterogeneity of the putative anti-inflammatory function of convalescent plasma (CP) in addition to passively providing neutralizing antibodies. RESULTS While across all age-groups primary clinical outcomes were not significantly different in the RCT, significant immediate mitigation of hypoxia, reduction in hospital stay as well as significant survival benefit were registered in younger (<67 years in our cohort) severe COVID-19 patients with ARDS on receiving CPT. In addition to neutralizing antibody content of convalescent plasma, its anti-inflammatory proteome on attenuation of systemic cytokine deluge, significantly contributed to the clinical benefits of CPT. CONCLUSION The sub-group analyses revealed that clinical benefit of CPT in severe COVID-19 is linked to the anti-inflammatory protein content of CP, apart from the anti-SARS-CoV-2 neutralizing antibody content.

Abstract

BACKGROUND Antiviral therapy has a greater impact when provided early in the disease to outpatients, potentially preventing hospitalization and subsequent deaths, while reducing healthcare system pressure. Controversies persist about the best treatment option for COVID-19 outpatients at risk of disease progression to hospital. No head-to-head RCT has been conducted to compare the three major modalities in current use-oral/intravenous antivirals, monoclonal antibodies and COVID-19 convalescent plasma (CCP). METHODS We assembled data from March 2020 to April 2022 from published outpatient RCTs examining authorized COVID-19 therapies with hospitalization as the major endpoint, and that also assessed mortality, symptom resolution, underlying risk factors for progression, timing and dose of the intervention in relationship to evolving variants of concern (VOC). FINDINGS CCP, monoclonal antibodies and oral antivirals each had comparable efficacy converging to 80% hospital risk reduction dependent on the dose and the timing of the intervention. Most RCTs targeted populations with at least one risk factor for severe COVID-19. Control group hospitalizations were less than 10% in 16 of 20 RCTs. Amongst the effective two CCP trials, monoclonals and three antiviral small molecules, deaths were reduced by 90% from 44 total in combined control arm to 4 in intervention arms. The overall risk of bias was deemed low for nine studies and some concerns for eight. The I (2) statistic heterogeneity amongst the outpatient trials with endpoint hospitalization is 72% (p-< 0.01). INTERPRETATION The emerging resistance of Omicron BA.2 and related sublineages (XE, BA.2.12.1, BA.4, and BA.5) to monoclonal antibodies suggests a pressing need to reevaluate CCP (nowadays largely available from vaccinees with high neutralizing antibody levels) for COVID19 outpatients at risk of disease progression, especially in settings with constrained medical resources. FUNDING This study was funded by the US Department of Defense, in collaboration with the Defense Health Agency and NIH. RESEARCH IN CONTEXT Evidence before this study: To date no head-to-head randomized controlled trial (RCT) has ever compared treatment options for COVID-19 outpatients, making comparisons and treatment choices difficult. We assembled RCTs with hospitalization as the primary endpoint. A literature search of MEDLINE (through PubMed), medRxiv and bioRxiv databases was carried out inclusive of RCTs published from March 2020 to April 2022 inclusive, using the search terms ("COVID-19" OR "SARS-CoV-2" OR "coronavirus disease 2019") AND ("treatment" OR "therapy") AND ("outpatient" OR "hospitalization"). The risk of bias obtained at COVID-19-Network Meta-Analysis (NMA), was low in half of the studies with some concerns for the remaining.Added value of this study: This systematic review compared outcomes among RCTs of outpatient therapy for COVID-19, taking into account time between onset of symptoms and treatment administration. We found that small-chemical antivirals, convalescent plasma and anti-Spike monoclonal antibodies had comparable efficacy. Trials of monoclonals were performed prior to the recognition that they had become ineffective against the Omicron sublineages.Implications of all the available evidence: Monoclonal antibodies and small chemical antivirals each have drawbacks. Both take time to be developed and are expensive. Monoclonals can lose efficacy with viral mutation, and chemical antivirals have contraindications and adverse events. Convalescent plasma retains its potency and is likely to be the only accessible therapeutic option for low-and-middle income countries.

Abstract

BACKGROUND Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain. METHODS In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion. RESULTS Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized. CONCLUSIONS In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).

Abstract

BACKGROUND Due to the critical condition of COVID-19, it is necessary to evaluate the efficacy of administrating convalescent plasma to COVID-19 patients. Therefore, we decided to design a clinical trial to investigate the effect of convalescent plasma of patients recovered from COVID-19 on the treatment outcome of COVID-19-infected patients. MATERIALS AND METHODS In this parallel randomized controlled clinical trial, patients in the intervention group received standard treatment plus convalescent plasma of patients recovered from COVID-19. We allocated 60 patients to each treatment group through balanced block randomization. Then, COVID-19 outcomes, vital signs, and biochemical parameters were compared between the two treatment groups by the independent t test and ANCOVA. RESULTS The mean age (SD) of the patients in the intervention and standard treatment groups was 52.84 (15.77) and 55.15 (14.34) years, respectively. Although patients in the intervention group reported more hospitalization days (11.45±5.86 vs. 10.42±6.79), death rates (26.67% vs. 18.13%), ICU admission (45 vs. 41.67%), and ARDS (11.67% vs. 3.33%), these differences were not statistically significant (P>0.05). Moreover, the two groups were homogenous in vital signs and biochemical parameters before and after treatment (P>0.05). CONCLUSION The present study indicated that convalescent plasma therapy has no significant effect on the survival, hospitalization, and ICU admission of COVID-19 patients.

Abstract

To assess whether high-dose coronavirus disease (COVID-19) convalescent plasma (CCP) transfusion may benefit patients with severe COVID-19, we conducted a multicenter randomized trial in Brazil. Patients with severe COVID-19 who were within 10 days of initial symptom onset were eligible. Patients in the CCP group received 3 daily doses of CCP (600 mL/d) in addition to standard treatment; control patients received standard treatment only. Primary outcomes were death rates at days 30 and 60 of study randomization. Secondary outcomes were ventilator-free days and hospital-free days. We enrolled 107 patients: 36 CCP and 71 control. At day 30, death rates were 22% for CCP and 25% for the control group; at day 60, rates were 31% for CCP and 35% for control. Needs for invasive mechanical ventilation and durations of hospital stay were similar between groups. We conclude that high-dose CCP transfused within 10 days of symptom onset provided no benefit for patients with severe COVID-19.