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1.
Hematology Am Soc Hematol Educ Program ; 2022(1): 96-104, 2022 12 09.
Article in English | MEDLINE | ID: covidwho-2241879

ABSTRACT

The serologic evaluation of autoimmune hemolytic anemia (AIHA) confirms the clinical diagnosis, helps distinguish the type of AIHA, and identifies whether any underlying alloantibodies are present that might complicate the selection of the safest blood for any needed transfusion. The spectrum of testing is generally dependent on the amount and class (immunoglobulin G or M) of autoantibody as well as the resources and methodologies where testing is performed. The approach may range from routine pretransfusion testing, including the direct antiglobulin test, to advanced techniques such as adsorptions, elution, and red cell genotyping. When transfusion is needed, the selection of the optimal unit of red blood cells is based on urgency and whether time allows for the completion of sophisticated serologic and molecular testing methods. From the start of when AIHA is suspected until the completion of testing, communication among the clinical team and medical laboratory scientists in the transfusion service and immunohematology reference laboratory is critical as testing can take several hours and the need for transfusion may be urgent. The frequent exchange of information including the patient's transfusion history and clinical status, the progress of testing, and any available results is invaluable for timely diagnosis, ongoing management of the patient, and the safety of transfusion if required before testing is complete.


Subject(s)
Anemia, Hemolytic, Autoimmune , Humans , Anemia, Hemolytic, Autoimmune/diagnosis , Anemia, Hemolytic, Autoimmune/therapy , Blood Transfusion/methods , Erythrocytes , Isoantibodies , Autoantibodies
2.
J Thorac Cardiovasc Surg ; 164(6): e449-e456, 2022 12.
Article in English | MEDLINE | ID: covidwho-2000583

ABSTRACT

For yet another year, our lives have been dominated by a pandemic. This year in review, we feature an expert panel opinion regarding extracorporeal support in the context of COVID-19, challenging previously held standards. We also feature survey results assessing the impact of the pandemic on cardiac surgical volume. Furthermore, we focus on a single center experience that evaluated the use of pulmonary artery catheters and the comparison of transfusion strategies in the Restrictive and Liberal Transfusion Strategies in Patients With Acute Myocardial Infarction (REALITY) trial. Additionally, we address the impact of acute kidney injury on cardiac surgery and highlight the controversy regarding the choice of fluid resuscitation. We close with an evaluation of dysphagia in cardiac surgery and the impact of prehabilitation to optimize surgical outcomes.


Subject(s)
COVID-19 , Cardiac Surgical Procedures , Humans , Erythrocyte Transfusion/methods , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/methods , Blood Transfusion/methods , Critical Care
3.
Vox Sang ; 117(5): 729-732, 2022 May.
Article in English | MEDLINE | ID: covidwho-1840538

ABSTRACT

BACKGROUND AND OBJECTIVES: An outbreak of coronavirus disease 2019 (COVID-19) occurred in mid-May of 2021 in Taiwan. After 2 months of hard work, transmissions were successfully prevented and the number of newly confirmed COVID-19 cases fell remarkably. We evaluated the impact of this outbreak on the massive transfusion protocol (MTP) in the emergency department (ED) of a trauma centre. MATERIALS AND METHODS: We retrospectively compared the activation and efficacy of MTP before, during and after the outbreak by analysing the clinical data relevant to MTP activations. RESULTS: There was no remarkable change in the average number of MTP triggers per month during the outbreak. The interval from an MTP trigger to the first unit of blood transfused at bedside was significantly increased during the outbreak compared to that before the outbreak (22.4 min vs. 13.9 min, p < 0.001); while the 24-h survival rate decreased (57.1% vs. 71.1%, p = 0.938). There were no remarkable changes in blood unit return or wastage during the outbreak. CONCLUSION: The COVID-19 outbreak limitedly affected MTP activation and waste of blood products, but significantly increased the interval from an MTP trigger to the first unit of blood transfused at bedside.


Subject(s)
COVID-19 , Wounds and Injuries , Blood Transfusion/methods , COVID-19/epidemiology , COVID-19/therapy , Disease Outbreaks , Humans , Retrospective Studies , Trauma Centers
4.
Lancet Respir Med ; 9(5): 487-497, 2021 05.
Article in English | MEDLINE | ID: covidwho-1537196

ABSTRACT

BACKGROUND: Lung transplantation is a life-saving treatment for patients with end-stage lung disease; however, it is infrequently considered for patients with acute respiratory distress syndrome (ARDS) attributable to infectious causes. We aimed to describe the course of disease and early post-transplantation outcomes in critically ill patients with COVID-19 who failed to show lung recovery despite optimal medical management and were deemed to be at imminent risk of dying due to pulmonary complications. METHODS: We established a multi-institutional case series that included the first consecutive transplants for severe COVID-19-associated ARDS known to us in the USA, Italy, Austria, and India. De-identified data from participating centres-including information relating to patient demographics and pre-COVID-19 characteristics, pretransplantation disease course, perioperative challenges, pathology of explanted lungs, and post-transplantation outcomes-were collected by Northwestern University (Chicago, IL, USA) and analysed. FINDINGS: Between May 1 and Sept 30, 2020, 12 patients with COVID-19-associated ARDS underwent bilateral lung transplantation at six high-volume transplant centres in the USA (eight recipients at three centres), Italy (two recipients at one centre), Austria (one recipient), and India (one recipient). The median age of recipients was 48 years (IQR 41-51); three of the 12 patients were female. Chest imaging before transplantation showed severe lung damage that did not improve despite prolonged mechanical ventilation and extracorporeal membrane oxygenation. The lung transplant procedure was technically challenging, with severe pleural adhesions, hilar lymphadenopathy, and increased intraoperative transfusion requirements. Pathology of the explanted lungs showed extensive, ongoing acute lung injury with features of lung fibrosis. There was no recurrence of SARS-CoV-2 in the allografts. All patients with COVID-19 could be weaned off extracorporeal support and showed short-term survival similar to that of transplant recipients without COVID-19. INTERPRETATION: The findings from our report show that lung transplantation is the only option for survival in some patients with severe, unresolving COVID-19-associated ARDS, and that the procedure can be done successfully, with good early post-transplantation outcomes, in carefully selected patients. FUNDING: National Institutes of Health. VIDEO ABSTRACT.


Subject(s)
COVID-19 , Critical Illness/therapy , Lung Transplantation/methods , Lung , Respiratory Distress Syndrome , Blood Transfusion/methods , COVID-19/complications , COVID-19/diagnosis , COVID-19/physiopathology , COVID-19/surgery , Critical Care/methods , Extracorporeal Membrane Oxygenation/methods , Female , Humans , Intraoperative Care/methods , Lung/diagnostic imaging , Lung/pathology , Male , Middle Aged , Outcome and Process Assessment, Health Care , Pulmonary Fibrosis/etiology , Pulmonary Fibrosis/pathology , Respiration, Artificial/methods , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/surgery , SARS-CoV-2/pathogenicity
5.
Transfus Apher Sci ; 61(1): 103297, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1472191

ABSTRACT

INTRODUCTION: The COVID-19 pandemic has resulted in severe ongoing blood shortages across the US, despite employment of numerous blood-conservation measures. Massive transfusion protocols (MTP) are one resource-intensive practice that utilize significant amounts of blood products. Alterations to the composition of MTP parameters to conserve scarce biologic resources have hitherto not been examined during the pandemic. METHODS: An anonymous 18-question survey was administered to 115 hospitals with valid email contact information. Survey questions addressed whether institutions have altered their MTPs due to the COVID-19 pandemic and blood shortages, and if so, what adjustments they have made. Additional details concerning potential differences in the number and cycles of MTPs and blood product wastage during the COVID-19 pandemic compared to the year prior were assessed. RESULTS: 50 responses were received (43 % response rate). 10 % (5/50) of institutions altered their MTPs utilizing a variety of approaches in attempt to conserve blood during the COVID-19 pandemic. Four additional institutions intend to alter them if it becomes necessary. Following onset of the COVID-19 pandemic, 24 % of institutions (12/50) reported an increase in monthly MTP activations, while 16 % (8/50) reported decreased activations compared to prior to the pandemic. 22 % (11/50) of institutions experienced increased blood wastage, whereas 16 % (8/50) reported decreased waste compared to pre-pandemic. DISCUSSION: The results of this survey highlight a variety of mechanisms by which institutions have attempted to conserve blood via altering MTPs. Whether an institution adjusted their MTP does not correlate with changes in blood product wastage compared to pre-pandemic.


Subject(s)
Blood Transfusion/methods , Clinical Protocols/standards , Hospitals , Humans , Pandemics , Surveys and Questionnaires
6.
Eur Rev Med Pharmacol Sci ; 25(18): 5871-5875, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1451046

ABSTRACT

OBJECTIVE: Post-acute sequelae of SARS-CoV2 infection (PASC) are a novel terminology used to describe post-COVID persistent symptoms, mimicking somehow the previously described chronic fatigue syndrome (CFS). In this manuscript, we evaluated a therapeutical approach to address PASC-derived fatigue in a cohort of past-COVID-19 positive patients. PATIENTS AND METHODS: A number of 100 patients, previously diagnosed as COVID-19 positive subjects and meeting our eligibility criteria, was diagnosed having PASC-related fatigue. They were recruited in the study and treated with oxygen-ozone autohemotherapy (O2-O3-AHT), according to the SIOOT protocol. Patients' response to O2-O3-AHT and changes in fatigue were measured with the 7-scoring Fatigue Severity Scale (FSS), according to previously published protocols. RESULTS: Statistics assessed that the effects of O2-O3-AHT on fatigue reduced PASC symptoms by 67%, as a mean, in all the investigated cohort of patients (H = 148.4786 p < 0.0001) (Figure 1). Patients following O2-O3-AHT therapy, quite completely recovered for PASC-associated fatigue, a quote amounting to about two fifths (around 40%) of the whole cohort undergoing ozone treatment and despite most of patients were female subjects, the effect was not influenced by sex distribution (H = 0.7353, p = 0.39117). CONCLUSIONS: Ozone therapy is able to recover normal functionality and to relief pain and discomfort in the form of PASC-associated fatigue in at least 67% of patients suffering from post-COVID sequelae, aside from sex and age distribution.


Subject(s)
Blood Transfusion/methods , COVID-19/complications , Fatigue Syndrome, Chronic/etiology , Fatigue Syndrome, Chronic/therapy , Oxygen/administration & dosage , Ozone/administration & dosage , Adult , Aged , Aged, 80 and over , COVID-19/therapy , Female , Humans , Male , Middle Aged , Severity of Illness Index , Surveys and Questionnaires , Post-Acute COVID-19 Syndrome
8.
Transfusion ; 61 Suppl 1: S313-S325, 2021 07.
Article in English | MEDLINE | ID: covidwho-1358635

ABSTRACT

BACKGROUND: The current global pandemic has created unprecedented challenges in the blood supply network. Given the recent shortages, there must be a civilian plan for massively bleeding patients when there are no blood products on the shelf. Recognizing that the time to death in bleeding patients is less than 2 h, timely resupply from unaffected locations is not possible. One solution is to transfuse emergency untested whole blood (EUWB), similar to the extensive military experience fine-tuned over the last 19 years. While this concept is anathema in current civilian transfusion practice, it seems prudent to have a vetted plan in place. METHODS AND MATERIALS: During the early stages of the 2020 global pandemic, a multidisciplinary and international group of clinicians with broad experience in transfusion medicine communicated routinely. The result is a planning document that provides both background information and a high-level guide on how to emergently deliver EUWB for patients who would otherwise die of hemorrhage. RESULTS AND CONCLUSIONS: Similar plans have been utilized in remote locations, both on the battlefield and in civilian practice. The proposed recommendations are designed to provide high-level guidance for experienced blood bankers, transfusion experts, clinicians, and health authorities. Like with all emergency preparedness, it is always better to have a well-thought-out and trained plan in place, rather than trying to develop a hasty plan in the midst of a disaster. We need to prevent the potential for empty shelves and bleeding patients dying for lack of blood.


Subject(s)
Blood Banks , Blood Banks/methods , Blood Preservation/methods , Blood Transfusion/methods , COVID-19/epidemiology , Civil Defense , Emergency Service, Hospital , Humans , Pandemics
9.
Transfusion ; 61(8): 2250-2254, 2021 08.
Article in English | MEDLINE | ID: covidwho-1346017

ABSTRACT

BACKGROUND: The year 2020 presented the transfusion community with unprecedented events and challenges, including the ongoing SARS-CoV-2 (COVID-19) pandemic, and more recently by civil unrest, following the death of George Floyd in late May of 2020. As a level 1 trauma center located in Minneapolis, Minnesota, Hennepin Healthcare (HCMC) offers a unique perspective into the changes in massive transfusion protocol (MTP) activations and usage during this tumultuous period. This may provide insight for addressing similar future events. STUDY DESIGN AND METHODS: MTP logs from March 2020 to August 2020 were compared to logs from March to August 2019. The data were de-identified, and MTP activations and component usage were categorized by activation reason. These categories were compared across the 2-year period to examine the impact of COVID-19, including stay-at-home orders, and civil unrest. RESULTS: For the examined 6 months of the year 2020, there were a total of 140 MTP activations, compared to 143 in 2019. There were more activations for violent trauma (VT) in 2020 than 2019 (44 vs. 32). This increase in activations for VT was offset by a decrease in non-trauma activations (54 vs. 66). There was a significant increase in the number of components used in VT activations. DISCUSSION: During 2020, the initial mild decrease in MTP activations was followed by a dramatic increase in the number of activations and component usage for VT in June and July of that year.


Subject(s)
Blood Transfusion/methods , COVID-19 , COVID-19/epidemiology , Civil Disorders , Humans , Minnesota/epidemiology , Pandemics , Trauma Centers
12.
Vox Sang ; 116(5): 574-580, 2021 May.
Article in English | MEDLINE | ID: covidwho-1241035

ABSTRACT

BACKGROUND: The COVID-19 outbreak has affected almost all hospital departments, including transfusion services. However, the demand for transfusions in a general hospital designated to deal with COVID-19 patients has not been analysed before. STUDY DESIGN AND METHODS: A retrospective study was conducted to evaluate blood transfusion practices from 15 March to 14 April 2020 at Hospital Universitario Infanta Leonor (Madrid, Spain). During this month, with few exceptions, the hospital became a 'COVID-19' centre. In addition, transfusion rates during this time frame and the same period over the last 4 years were compared. RESULTS: From 15 March to 14 April 2020, only 254 blood components were transfused, resulting in a 49·3% reduction over the previous year. Interestingly, in critically ill patients, the red blood cell (RBC) transfusion/bed ratio significantly decreased during this period (0·92) compared to the same ratio over the past 4 years (2·70) (P = 0·02). Of note, 106 blood components (95 RBC; 11 platelet concentrates) were transfused to only 36 out of 1348 COVID-19 patients (2·7%). The main reason for RBC transfusion in COVID-19 patients was a previous underlying disease (44%) followed by bleeding (25%) and inflammatory anaemia (25%). CONCLUSION: This is the first study to report a decrease in blood transfusions during the COVID-19 pandemic in a general hospital and especially in the intensive care unit. The results of this study suggest that COVID-19 does not generally induce transfusion requiring anaemia, being the main causes for transfusion in these patients underlying conditions or bleeding.


Subject(s)
Blood Transfusion/statistics & numerical data , COVID-19/therapy , Hospitals, General/statistics & numerical data , Blood Transfusion/methods , Blood Transfusion/standards , COVID-19/epidemiology , Humans , Spain
13.
Transfusion ; 61(7): 2075-2081, 2021 07.
Article in English | MEDLINE | ID: covidwho-1195802

ABSTRACT

BACKGROUND: Blood usage and collections were impacted throughout 2020 both by the severity of the COVID-19 pandemic as well as public health decisions affecting hospital operations. We sought to understand the longer-term effects of the pandemic on blood usage via changes in case volume and clinical intensity as well as whether the blood needs of COVID-19-positive patients differed from other transfused patients. STUDY DESIGN AND METHODS: A single-center retrospective study of blood use in 2020 as compared to 2014-2019 was conducted at a tertiary care center. Statistical analysis was performed in an R-based workflow. p values are reported using two-sided t-tests for total hospital blood usage and using Mann-Whitney U tests for comparisons of patient blood usage. RESULTS: Mean monthly red cell usage in 2020 decreased by 11.2% (p = .003), plasma usage decreased by 23.8%, (p < .001) platelet usage decreased by 11.4% (p < .001), and monthly cryoprecipitate use increased by 18% (p = .03). A linear regression model predicted significant associations between total blood usage and the year, number of Medicare eligible discharges, and Case Mix Index. COVID-19-positive patients requiring at least one blood product did not use significantly different amounts of red cells, plasma, or platelets from all other transfused patients. CONCLUSIONS: Year 2020 began with decreased blood usage that was normalized by late spring. Reassuringly, transfused COVID-19-positive patients in general and those requiring ICU level care do not use significantly increased amounts of blood as compared to similar transfused hospital patients.


Subject(s)
Blood Transfusion/statistics & numerical data , COVID-19/epidemiology , Pandemics , Blood Transfusion/methods , COVID-19/virology , Humans , Maryland/epidemiology , Public Health Surveillance , SARS-CoV-2
14.
J Heart Lung Transplant ; 40(7): 631-641, 2021 07.
Article in English | MEDLINE | ID: covidwho-1157308

ABSTRACT

BACKGROUND: The shortage of blood products has become a worldwide problem, especially during the COVID-19 Pandemic. Here, we investigated whether a point of care (POC) approach to perioperative bleeding and coagulopathy based on rotational thromboelastometry (ROTEM) results could decrease perioperative blood loss and the perioperative consumption of blood products during lung transplantation. METHODS: Patients undergoing bilateral lung transplantation were randomized into two groups: In the first group, designated the "non POC" group, the management of perioperative bleeding and coagulopathy was based on the clinical experience of the anesthesiologist; in the second group, designated the "POC" group, the management of perioperative bleeding, and coagulopathy was based on the ROTEM results. RESULTS: After performing an interim statistical analysis, the project was prematurely terminated as the results were significantly in favor of the POC approach. Data were analyzed for the period January 2018 until June 2020 when 67 patients were recruited into the study. There was significantly decreased perioperative blood loss in the POC group (n = 31 patients) with p = 0.013, decreased perioperative consumption of RBC with p = 0.009, and decreased perioperative consumption of fresh frozen plasma with p < 0.0001 (practically no fresh frozen plasma was used in the POC group) without deteriorating clot formation in secondary and primary hemostasis as compared to the non POC group (n = 36). CONCLUSION: POC management of perioperative bleeding and coagulopathy based on ROTEM results is a promising strategy to decrease perioperative blood loss and the consumption of blood products in lung transplantation.


Subject(s)
Blood Coagulation Disorders/diagnosis , COVID-19/epidemiology , Hemostasis/physiology , Lung Transplantation/adverse effects , Pandemics , Thrombelastography/methods , Blood Coagulation Disorders/etiology , Blood Coagulation Disorders/therapy , Blood Transfusion/methods , Female , Humans , Male , Middle Aged , SARS-CoV-2
17.
Transfusion ; 61(2): 361-367, 2021 02.
Article in English | MEDLINE | ID: covidwho-907629

ABSTRACT

BACKGROUND: During the COVID-19 outbreak, most hospitals deferred elective surgical procedures to allow space for the overwhelming number of COVID-19 patient admissions, expecting a decrease in routine blood component requirements. However, because transfusion support needs of COVID-19 patients are not well known, its impact on hospital blood supply is uncertain. The objective of this study was to assess the effect of the COVID-19 pandemic on transfusion demand. STUDY DESIGN AND METHODS: Transfusion records during the peak of the COVID-19 pandemic (March 1-April 30, 2020) were reviewed in our center to assess changes in blood requirements. RESULTS: During this period 636 patients received a total of 2934 blood components, which reflects a 17.6% reduction in transfusion requirements with regard to the same period of 2019, and blood donations in Madrid dropped by 45%. The surgical blood demand decreased significantly during the outbreak (50.2%). Blood usage in the hematology and oncology departments remained unchanged, while the day ward demand halved, and intensive care unit transfusion needs increased by 116%. A total of 6.2% of all COVID inpatients required transfusion support. COVID-19 inpatients consumed 19% of all blood components, which counterbalanced the savings owed to the reduction in elective procedures. CONCLUSION: Although only a minority of COVID-19 inpatients required transfusion, the expected reduction in transfusion needs caused by the lack of elective surgical procedures is partially offset by the large number of admitted patients during the peak of the pandemic. This fact must be taken into account when planning hospital blood supply.


Subject(s)
Blood Transfusion/methods , COVID-19/therapy , SARS-CoV-2/pathogenicity , Aged , Blood Component Transfusion/methods , Blood Donors , COVID-19/virology , Disease Outbreaks , Female , Hospitals , Humans , Male , Middle Aged , Pandemics
18.
Trials ; 21(1): 883, 2020 Oct 26.
Article in English | MEDLINE | ID: covidwho-892368

ABSTRACT

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 room air or PaO2/FiO2≤ 300 mm of Hg, PLUS 3. Radiological (X-ray or CT scan) evidence of bilateral lung infiltrate, AND OR 4. Systolic BP < 90 mm of Hg or diastolic BP <60 mm of Hg. AND/OR 5. Criteria 1 to 4 AND or patient in ventilator support Patients' below18 years, pregnant and lactating women, previous history of allergic reaction to plasma, patients who have already received plasma from a different source will be excluded. Patients will be enrolled at Bangabandhu Sheikh Mujib Medical University (BSMMU) hospital, Dhaka medical college hospital (DMCH) and Mugda medical college hospital (MuMCH). Apheretic plasma will be collected at the transfusion medicine department of SHNIBPS hospital, ELISA antibody titre will be done at BSMMU and CMBT and neutralizing antibody titre will be checked in collaboration with the University of Oxford. Patients who have recovered from COVID-19 will be recruited as donors of CP. The recovery criteria are normality of body temperature for more than 3 days, resolution of respiratory symptoms, two consecutively negative results of sputum SARS-CoV-2 by RT-PCR assay (at least 24 hours apart) 22 to 35 days of post onset period, and neutralizing antibody titre ≥ 1:160. INTERVENTION AND COMPARATOR: This RCT consists of three arms, a. standard care, b. standard care and 200 ml CP and c. standard care and 400 ml CP. Patients will receive plasma as a single transfusion. Intervention arms will be compared to the standard care arm. MAIN OUTCOMES: The primary outcome will be time to clinical improvement within seven days of treatment or until discharge whichever is later and in-hospital mortality. The secondary outcome would be improvement of laboratory parameters after therapy (neutrophil, lymphocyte ratio, CRP, serum ferritin, SGPT, SGOT, serum creatinine and radiology), length of hospital stay, length of ICU stay, reduction in proportion of deaths, requirement of ventilator and duration of oxygen and ventilator support. RANDOMISATION: Randomization will be done by someone not associated with the care or assessment of the patients by means of a computer generated random number table using an allocation ratio of 1:1:1. BLINDING (MASKING): This is an open level study; neither the physician nor the patients will be blinded. However, the primary and secondary outcome (oxygen saturations, PaO2/FiO2, BP, day specific laboratory tests) will be recorded using an objective automated method; the study staff will not be able to influence the recording of these data. NUMBER TO BE RANDOMISED (SAMPLE SIZE): No similar study has been performed previously. Therefore no data are available that could be used to generate a sample size calculation. This phase II study is required to provide some initial data on efficacy and safety that will allow design of a larger study. The trial will recruit 60 participants (20 in each arm). TRIAL STATUS: Protocol version 1.4 dated May 5, 2020 and amended version 1.5, dated June 16, 2020. First case was recruited on May 27, 2020. By August 10, 2020, the trial had recruited one-third (21 out of 60) of the participants. The recruitment is expected to finish by October 31, 2020. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT04403477 . Registered 26 May, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trial's website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.


Subject(s)
Betacoronavirus/genetics , Blood Transfusion/methods , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Bangladesh/epidemiology , COVID-19 , Coronavirus Infections/epidemiology , Coronavirus Infections/virology , Dose-Response Relationship, Immunologic , Female , Hospital Mortality/trends , Humans , Immunization, Passive/adverse effects , Immunization, Passive/methods , Male , Pandemics , Patient Discharge/statistics & numerical data , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , SARS-CoV-2 , Safety , Severity of Illness Index , Time Factors , Treatment Outcome , Ventilators, Mechanical/statistics & numerical data , COVID-19 Serotherapy
19.
Trials ; 21(1): 875, 2020 Oct 22.
Article in English | MEDLINE | ID: covidwho-886002

ABSTRACT

OBJECTIVES: The primary objective is to demonstrate that COVID-19 convalescent plasma (CCP) prevents progression to severe pneumonia in elderly COVID-19 pneumonia patients with chronic comorbidities. Secondary objectives are to demonstrate that CCP decreases the viral load in nasopharyngeal swabs and increases the anti-SARS-CoV-2 antibody titre in recipients. TRIAL DESIGN: This is a randomized, open-label, parallel group, phase II/III study with a superiority framework. The trial starts with a screening phase II designed with two-tailed alpha=0.2. In case of positive results, the trial will proceed in a formally comparative phase III (alpha=0.05). PARTICIPANTS: Adult patients with confirmed or suspected COVID-19 who are at risk according to CDC definition are eligible. Inclusion criteria are all the following: age ≥ 65; pneumonia at CT scan; PaO2/FiO2 ≥300 mmHg; presence of one or more comorbidities; signed informed consent. Exclusion criteria are one of the following: age < 65; PaO2/FiO2 < 300 mmHg; pending cardiopulmonary arrest; refusal to blood product transfusions; severe IgA deficiency; any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion. The trial is being conducted at three reference COVID-19 centres in the middle of Italy. INTERVENTION AND COMPARATOR: Intervention: COVID-19 Convalescent Plasma (CCP) in addition to standard therapy. Patients receive three doses (200 ml/day on 3 consecutive days) of ABO matched CCP. Comparator: Standard therapy MAIN OUTCOMES: A. Primary outcome for Phase II: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO by day 14. B. Primary outcome for Phase III: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO by day 14. Secondary outcomes for Phase III: Decreased viral load on nasopharyngeal swab at days 6, 9 and 14; Decreased viremia at days 6 and 9; Increased antibody titer against SARS-CoV2 at days 30 and 60; Proportion of patients with negative of SARS-CoV2 nasopharyngeal swab at day 30; Length of hospital stay; Mortality rate at day 28; Total plasma related adverse event (day 60); Total non-plasma related adverse events (day 60); Severe adverse events (SAE) (day 60). RANDOMISATION: Treatment allocation is randomized with a ratio 1:1 in both phase II and phase III. Randomization sequences will be generated at Fondazione Policlinico Gemelli IRCCS through the RedCap web application. Randomized stratification is performed according to age (under/over 80 years), and sex. BLINDING (MASKING): None, this is an open-label trial. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Phase II: 114 patients (57 per arm). Phase III: 182 patients (91 per arm) TRIAL STATUS: The trial recruitment started on May 27, 2020. The anticipated date of recruitment completion is April 30, 2021. The protocol version is 2 (May 10, 2020). TRIAL REGISTRATION: The trial has been registered on ClinicalTrials.gov (May 5, 2020). The Identifier number is NCT04374526 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Betacoronavirus/genetics , Blood Transfusion/methods , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Aged , Aged, 80 and over , Betacoronavirus/immunology , COVID-19 , Comorbidity , Coronavirus Infections/epidemiology , Coronavirus Infections/virology , Disease Progression , Female , Humans , Immunization, Passive/adverse effects , Immunization, Passive/methods , Informed Consent/ethics , Italy/epidemiology , Male , Mortality/trends , Pandemics , Pneumonia/diagnostic imaging , Pneumonia/prevention & control , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , SARS-CoV-2 , Tomography, X-Ray Computed/methods , Viral Load/immunology , Viral Load/statistics & numerical data , COVID-19 Serotherapy
20.
Bone Marrow Transplant ; 56(2): 305-313, 2021 02.
Article in English | MEDLINE | ID: covidwho-803158

ABSTRACT

On January 20, 2020, the first patient with coronavirus disease 2019 (COVID-19) in the United States of America was diagnosed in Washington state, which subsequently experienced rapidly increasing numbers of COVID-19 cases, hospitalizations, and deaths. This placed the Seattle Blood and Marrow Transplant Program at Fred Hutchinson Cancer Research Center (Fred Hutch) in the national epicenter of this pandemic. Here, we summarize the experience gained during our rapid response to the COVID-19 pandemic. Our efforts were aimed at safely performing urgent and potentially life-saving stem cell transplants in the setting of pandemic-related stresses on healthcare resources and shelter-in-place public health measures. We describe the unique circumstances and challenges encountered, the current state of the program amidst evolving COVID-19 cases in our community, and the guiding principles for recovery. We also estimate the collateral impact of directing clinical resources toward COVID-19-related care on cancer patients in need of stem cell transplantation. Although our experience was influenced by specific regional and institutional factors, it may help inform how transplant programs respond to COVID-19 and future pandemics.


Subject(s)
Blood Transfusion/methods , Bone Marrow Transplantation/methods , COVID-19/epidemiology , Transplantation Conditioning/methods , Humans , Pandemics , United States/epidemiology
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