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1.
Transplant Direct ; 6(7): e572, 2020 Jul.
Article in English | MEDLINE | ID: covidwho-1794966

ABSTRACT

BACKGROUND: The early effects of coronavirus disease 2019 (COVID-19) on transplantation are dramatic: >75% of kidney and liver programs are either suspended or operating under major restrictions. To resume transplantation, it is important to understand the prevalence of COVID-19 among transplant recipients, donors, and healthcare workers (HCWs) and its associated mortality. METHODS: To investigate this, we studied severe acute respiratory syndrome coronavirus 2 diagnostic test results among patients with end-stage renal disease or kidney transplants from the Johns Hopkins Health System (n = 235), and screening test results from deceased donors from the Southwest Transplant Alliance Organ Procurement Organization (n = 27), and donors, candidates, and HCWs from the National Kidney Registry and Viracor-Eurofins (n = 253) between February 23 and April 15, 2020. RESULTS: We found low rates of COVID-19 among donors and HCWs (0%-1%) who were screened, higher rates of diagnostic tests among patients with end-stage renal disease or kidney transplant (17%-20%), and considerable mortality (7%-13%) among those who tested positive. CONCLUSIONS: These findings suggest the threat of COVID-19 for the transplant population is significant and ongoing data collection and reporting is critical to inform transplant practices during and after the pandemic.

2.
Transplantation ; 105(7): 1405-1422, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1706459

ABSTRACT

The emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus responsible for the coronavirus disease 2019 (COVID-19) pandemic has raised concerns for programs overseeing donation and transplantation of cells, tissues, and organs (CTO) that this virus might be transmissible by transfusion or transplantation. Transplant recipients are considered particularly vulnerable to pathogens because of immunosuppression, and SARS-CoV-2 is likely to generate complications if contracted. Several signs and symptoms observed in COVID-19 positive patients reflect damage to multiple organs and tissues, raising the possibility of extrapulmonary SARS-CoV-2 infections and risk of transmission. At the beginning of the pandemic, a consensus has emerged not to consider COVID-19 positive patients as potential living or deceased donors, resulting in a global decrease in transplantation procedures. Medical decision-making at the time of organ allocation must consider safely alongside the survival advantages offered by transplantation. To address the risk of transmission by transplantation, this review summarizes the published cases of transplantation of cells or organs from donors infected with SARS-CoV-2 until January 2021 and assesses the current state of knowledge for the detection of this virus in different biologic specimens, cells, tissues, and organs. Evidence collected to date raises the possibility of SARS-CoV-2 infection and replication in some CTO, which makes it impossible to exclude transmission through transplantation. However, most studies focused on evaluating transmission under laboratory conditions with inconsistent findings, rendering the comparison of results difficult. Improved standardization of donors and CTO screening practices, along with a systematic follow-up of transplant recipients could facilitate the assessment of SARS-CoV-2 transmission risk by transplantation.


Subject(s)
COVID-19/transmission , Donor Selection/methods , Hematopoietic Stem Cell Transplantation/adverse effects , Organ Transplantation/adverse effects , Postoperative Complications/etiology , SARS-CoV-2/isolation & purification , COVID-19/diagnosis , COVID-19/prevention & control , COVID-19/virology , Humans , Postoperative Complications/diagnosis , Postoperative Complications/prevention & control , Risk
4.
Curr Treat Options Cardiovasc Med ; 23(5): 28, 2021.
Article in English | MEDLINE | ID: covidwho-1298597

ABSTRACT

PURPOSE OF REVIEW: With increasing survival of patients with stage D heart failure, the demand for heart transplantation has increased. The supply of donor hearts remains relatively limited. Strategies have been investigated and new technologies have been developed to expand the current donor pool. These new approaches will be discussed herein. RECENT FINDINGS: Donor hearts are often considered "marginal" due to risk factors such as older age, size mismatch with the intended recipient, prolonged ischemic time, presence of left ventricular hypertrophy, and hepatitis B/C infection. We reviewed recent data regarding the use of donor hearts with these risk factors and suggest ways to safely liberalize current donor heart acceptance criteria. New technologies such as temperature-controlled transport systems and ex vivo cardiac perfusion methods have also demonstrated promising short-term and intermediate outcomes as compared with routine cold storage, by promoting heart preservation and enabling heart procurement from remote sites with shorter cold ischemic time. Recent use of hearts from donation after circulatory death donors has demonstrated comparable outcomes to conventional donation after brain death, which can further expand the current donor pool. SUMMARY: Careful selection of "marginal" donor hearts, use of ex vivo cardiac perfusion, and acceptance of hearts after circulatory death may expand our current cardiac donor pool with comparable outcomes to conventional donor selection and preparation methods.

5.
Orv Hetil ; 162(23): 890-896, 2021 06 06.
Article in Hungarian | MEDLINE | ID: covidwho-1259268

ABSTRACT

Összefoglaló. Bevezetés: A SARS-CoV-2-világjárvány terjedése drasztikus változásokat okozott a mindennapi betegellátásban, amelyek érintették a szervadományozás és -átültetés területét is, így csökkent az élo és az elhunyt donorokból történo donációk és transzplantációk száma világszerte. Az esetszám csökkenése mellett a transzplantált és egyben immunszupprimált betegek védelme érdekében további biztonsági intézkedéseket kellett bevezetni. Módszer: A vizsgálat célja a COVID-19-járvány hazai donációs és transzplantációs aktivitásra gyakorolt hatásának kimutatása volt 2020-ban, a megelozo évvel történo összehasonlításban. A magyar eredményeket összehasonlítottuk elsosorban az Eurotransplant, illetve az Európai Unió tagállamainak adataival is. Eredmények: A lakosságszámra súlyozott, regisztrált COVID-19-fertozöttség és -halálozás tekintetében nem igazoltunk 2020-ban kiemelkedo eltérést itthon az Eurotransplant-tagállamokhoz képest. A hazai szervdonációs potenciál nem csökkent a vizsgált idoszakban, ugyanakkor 38,33%-kal csökkent az agyhalott szervdonorok száma Magyarországon, míg az Eurotransplantban átlagosan 8,64%-kal és 23 adatközlo európai országban 17,55%-kal. Az elhunytból történt szervátültetések száma 29,27%-kal csökkent, különösen a szív- és a májátültetések esetén. A külföldrol kapott szervek száma 21,13%-kal és aránya 12,34%-kal emelkedett. Az élo donoros veseátültetések száma nem változott. 2020-ban 25%-kal kevesebb új beteget regisztráltak, mint 2019-ben, és a várólista-mortalitás 28%-kal növekedett az elozo évhez képest, kifejezetten a veseátültetésre várók között. Következtetés: A hazai szervátültetési program biztonságos: donoreredetu SARS-CoV-2-átvitel nem történt hazánkban. A szervdonációs potenciál és a COVID-19-járvány mellett a szervdonációs és -transzplantációs aktivitás jelentosen csökkent Magyarországon 2020. márciustól az év végéig. A legtöbb európai országban átmeneti és kisebb mértéku szervdonációs csökkenést regisztráltak. A szervátültetések száma nem csökkent olyan mértékben, mint a donorszám, mert az Eurotransplantból több donorszerv érkezett hazánkba, mint amennyit külföldre küldtünk. Orv Hetil. 2021; 162(23): 890-896. INTRODUCTION: The spread of the SARS-CoV-2 pandemic has resulted in drastic changes in day-to-day patient care, which has also affected the field of organ donation and transplantation, thus reducing the number of donations and transplants from living and deceased donors worldwide. In addition to the reduction in the number of cases, additional safety measures had to be introduced to protect transplanted and implicatively immunosuppressed patients. METHOD: The aim of the study was to demonstrate the impact of the COVID-19 epidemic on domestic donation and transplantation activity in 2020, compared to the previous year. We also compared the Hungarian results with the data of the Eurotransplant and the European Union member states. RESULTS: In terms of population-weighted, registered COVID-19 infection and mortality, we did not find a significant difference in Hungary in 2020 compared to the Eurotransplant member states. The national organ donation potential did not diminish in the period under review, however, the number of brain-dead organ donors decreased by 38.33% in Hungary, while in the Eurotransplant it did by 8.64% on average and in 23 reporting European countries by 17.55%. The number of organ transplants from the deceased decreased by 29.27%, especially regarding heart and liver transplants. Both the number and the proportion of organs received from abroad increased by 21.13% and 12.34%, respectively. The number of living donor kidney transplants did not change. In 2020, 25% fewer new patients were registered than in 2019 and the mortality on waiting list increased by 28% compared to the previous year, especially among those waiting for a kidney transplant. CONCLUSION: The national organ transplantation program is safe: donor-derived SARS-CoV-2 transmission did not occur in Hungary. In addition to the organ donation potential and the COVID-19 pandemic, organ donation and transplantation activity decreased significantly in Hungary from March 2020 until the end of the year. Transient and smaller reductions in organ donation rates have been reported in most European countries. The number of organ transplants did not decrease as much as the number of donors, because more donor organs arrived in Hungary from the Eurotransplant than we sent abroad. Orv Hetil. 2021; 162(23): 890-896.


Subject(s)
COVID-19 , Organ Transplantation , Tissue and Organ Procurement , Europe , Humans , Hungary , Pandemics , SARS-CoV-2
6.
Rev Bras Enferm ; 74Suppl 1(Suppl 1): e20200610, 2021.
Article in English, Portuguese | MEDLINE | ID: covidwho-1197421

ABSTRACT

OBJECTIVES: to map the care recommendations available in the literature capable of supporting health professionals' decision-making in the organ and tissue donation process before the COVID-19 pandemic. METHODS: is a nine-step scoping review with searches performed in three databases and an electronic library (Science Direct). RESULTS: 873 publications were retrieved, 15 selected for analysis. All were published in 2020, originating mainly on China, with predominance of original articles. The most frequent recommendations relate to testing to detect SARS-CoV-2 infection for deceased donors (52.6%) and clinical evaluation of potential donors and possible donors (31.6%). FINAL CONSIDERATIONS: it is believed that the recommendations evidenced will support health professionals in the process of donation and organ transplantations to determine interventions for decision-making during the COVID-19 pandemic.


Subject(s)
COVID-19 , Coronavirus Infections , Tissue and Organ Procurement , China/epidemiology , Coronavirus Infections/epidemiology , Humans , Organ Transplantation , Pandemics , SARS-CoV-2
7.
Clin Transplant ; 35(5): e14280, 2021 05.
Article in English | MEDLINE | ID: covidwho-1150116

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic poses unprecedented challenges to the transplant community, including organ procurement organizations (OPOs), transplant centers, regulatory agencies, and recipient candidates. Access to timely, accurate information on the status of deceased donor viral infection is essential in determining organ acceptance. The Organ Procurement and Transplantation Network expeditiously added fields to collect these data; however, use of the data collection fields was not uniform nationally. Standardized, field-defined data capture and reporting are vital to ensure optimal organ utilization during this pandemic, and to prepare the community for subsequent challenges.


Subject(s)
COVID-19 , Tissue and Organ Procurement , Humans , Policy , SARS-CoV-2 , Tissue Donors
8.
Transpl Infect Dis ; 23(4): e13600, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1138250

ABSTRACT

INTRODUCTION: Hospital do Rim is a high-volume kidney transplant (KT) center located in São Paulo, a city with 12.2 million inhabitants. Over the last 18 years, we performed 11 436 KT, 70% of which from deceased donors. To mitigate the effects of reduction in the number of transplants on the waiting list, sequential measures were implemented when COVID-19 was declared pandemic. METHODS: The first step was to provide SARS-COV-2 RT-PCR testing for all symptomatic employees and patients and the compulsory use of personal protective equipment in the hospital facilities. Living donor KT were postponed, and all deceased donors and recipients were tested before the transplantation. The immunosuppressive protocols were maintained, and telehealth strategies were developed. RESULTS: Among the 1013 employees, there were 214 cases of COVID-19, nine required ward hospitalization, and no deaths occurred. In 26%, the probable source of contamination was occupational. From the first patient diagnosed with COVID-19 in 03/20/2020 till 10/21/2020, 523 deceased KT were performed, a 21% increase compared with 2019, with no confirmed donor-derived SARS-CoV-2 infection. Four patients were transplanted with a positive pretransplant SARS-CoV-2 test, but none of them developed the disease. Overall, of 11 875 KT followed in our center, 674 developed COVID-19. Among the hospitalized, 53% required mechanical ventilation, and 45% required hemodialysis. Their overall mortality rate was 27.5%. CONCLUSION: This experience shows the challenges that transplant centers faced as the pandemic unfolded and illustrates the effectiveness of the sequential measures implemented to provide a safe environment for transplantation.


Subject(s)
COVID-19 , Kidney Transplantation , Brazil , Humans , Kidney Transplantation/adverse effects , Pandemics , SARS-CoV-2
9.
Transplant Proc ; 53(4): 1138-1142, 2021 May.
Article in English | MEDLINE | ID: covidwho-1085466

ABSTRACT

INTRODUCTION: In recent months, the number of kidney transplants from deceased donors has declined significantly. One of the reasons is the possibility of infection of the recipient with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Determining the risk of transmission of coronavirus disease 2019 (COVID-19) with a donor organ is very important for developing a kidney transplantation policy during a pandemic. MATERIALS AND METHOD: We present cases of kidney transplantation from COVID-19-positive deceased donors to 2 dialysis patients 49 and 45 years old. One of them was on hemodialysis for 28 months; the other received continuous ambulatory peritoneal dialysis (CAPD). Both patients received only basic immunosuppression, including tacrolimus, methylprednisolone, and mycophenolic acid. No antilymphocyte agents were used for induction therapy. RESULTS: Cold ischemia time was 22 and 21 hours, respectively. One recipient had delayed graft function with increasing of urine output on day 8; another had immediate function. Both patients had no febrile and no other symptoms of acute respiratory disease during their hospital stay. No abnormalities on the chest x-ray were seen. No serum anti-SARS-CoV-2 IgM and IgG were detected before and during 6 weeks after surgery. Repeated nasopharyngeal swabs real-time reverse transcription polymerase chain reaction (rRT-PCR) were negative during the period. Both recipients were discharged 5 weeks after surgery with serum creatinine levels of 122 and 91 mcmol/L, respectively. CONCLUSION: Today we have no evidence of the possibility of transmission of COVID-19 from a SARS-CoV-2 positive donor to a kidney recipient. We also have no reason to suspect kidney damage by COVID-19 in a deceased donor at normal serum creatinine level.


Subject(s)
COVID-19/transmission , Disease Transmission, Infectious/prevention & control , Donor Selection , Kidney Transplantation/methods , SARS-CoV-2 , Humans , Kidney/virology , Kidney Transplantation/adverse effects , Middle Aged , Postoperative Complications/prevention & control , Postoperative Complications/virology , Transplants/virology , Treatment Outcome
10.
JAMA Ophthalmol ; 139(4): 383-388, 2021 04 01.
Article in English | MEDLINE | ID: covidwho-1039144

ABSTRACT

Importance: Current recommendations are to avoid tissue for corneal transplant from donors with coronavirus disease 2019 (COVID-19) or those who were recently exposed to COVID-19 owing to the lack of knowledge about the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in corneal tissues. Evidence of SARS-CoV-2 in corneal tissue would seem to have clinical relevance for corneal transplant. Objectives: To investigate the presence of viral SARS-CoV-2 RNA in corneal discs of deceased patients with confirmed COVID-19 and assess viral genomic and subgenomic RNA load, possible infectivity, and histologic abnormalities. Design, Setting, and Participants: A case series was conducted of 11 deceased patients with COVID-19 who underwent autopsy between March 20 and May 14, 2020. Eleven corneal discs (1 corneal disc per patient) were harvested for molecular detection of viral genomic and subgenomic RNA, virus isolation, and immunohistochemistry. The SARS-CoV-2 RNA loads were compared with RNA loads in the conjunctival and throat swab samples and aqueous humor, vitreous humor, and blood samples. Main Outcomes and Measures: Evidence of SARS-CoV-2 RNA in human corneas. Results: This study comprised 11 patients (6 women [55%]; mean [SD] age, 68.5 [18.8] years). In 6 of 11 eyes (55%), SARS-CoV-2 genomic RNA was detected in the cornea; subgenomic RNA was present in 4 of these 6 eyes (67%). Infectivity or the presence of viral structural proteins could not be confirmed in any eye. However, patients whose corneal disc was positive for SARS-CoV-2 RNA also had positive results for SARS-CoV-2 RNA in 4 of 6 conjunctival swab samples, 1 of 3 aqueous humor samples, 3 of 5 vitreous humor samples, and 4 of 5 blood samples. Overall, conjunctival swab samples had positive results for SARS-CoV-2 RNA in 5 of 11 cases. Postmortem SARS-CoV-2 viremia was detected in 5 of 9 patients. Conclusions and Relevance: Viral genomic and subgenomic RNA of SARS-CoV-2 was detected in the cornea of patients with COVID-19 viremia. The risk of COVID-19 infection via corneal transplant is low even in donors with SARS-CoV-2 viremia, but further research is necessary to assess the rate of SARS-CoV-2 transmission via corneal transplant.


Subject(s)
COVID-19/virology , Cornea/virology , RNA, Viral/analysis , SARS-CoV-2/isolation & purification , Viremia/virology , Adult , Aged , Aged, 80 and over , Animals , Chlorocebus aethiops , Corneal Transplantation , Female , Humans , Immunohistochemistry , Male , Middle Aged , SARS-CoV-2/genetics , Vero Cells , Viral Load
11.
Am J Transplant ; 21(6): 2100-2112, 2021 06.
Article in English | MEDLINE | ID: covidwho-947734

ABSTRACT

COVID-19 has been sweeping the globe, hitting the United States particularly hard with a state of emergency declared on March 13, 2020. Transplant hospitals have taken various precautions to protect patients from potential exposure. OPTN donor, candidate, and transplant data were analyzed from January 5, 2020 to September 5, 2020. The number of new waiting list registrations decreased, with the Northeast seeing over a 50% decrease from the week of 3/8 versus the week of 4/5. The national transplant system saw near cessation of living donor transplantation (-90%) from the week of 3/8 to the week of 4/5. Similarly, deceased donor kidney transplant volume dropped from 367 to 202 (-45%), and other organs saw similar decreases: lung (-70%), heart (-43%), and liver (-37%). Deceased donors recovered dropped from 260 to 163 (-45%) from 3/8 compared to 4/5, including a 67% decrease for lungs recovered. The magnitude of this decrease varied by geographic area, with the largest percent change (-67%) in the Northeast. Despite the pandemic, discard rates across organ has remained stable. Although the COVID-19 pandemic continues to evolve, OPTN data show recent evidence of stabilization, an indication that an early recovery of the number of living and deceased donors and transplants has ensued.


Subject(s)
COVID-19 , Organ Transplantation , Tissue and Organ Procurement , Humans , Pandemics , SARS-CoV-2 , Tissue Donors , United States/epidemiology , Waiting Lists
12.
Transpl Infect Dis ; 23(2): e13503, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-917760

ABSTRACT

Although guidance documents have been published regarding organ donation from individuals with a prior history of COVID-19 infection, no data exist regarding successful recovery and transplantation from deceased donors with a history of or positive testing suggesting a prior SARS-CoV-2 infection. Here, we report a case series of six deceased donors with a history of COVID-19 from whom 13 organs were recovered and transplanted through several of the nation's organ procurement organizations (OPOs). In addition, at least two potential donors were authorized for donation but with no organs were successfully allocated and did not proceed to recovery. No transmission of SARS-CoV-2 was reported from the six donors to recipients, procurement teams, or hospital personnel. Although more studies are needed, organ donation from deceased donors who have recovered from COVID-19 should be considered.


Subject(s)
COVID-19/diagnosis , Heart Transplantation , Kidney Transplantation , Liver Transplantation , Tissue and Organ Harvesting , Adult , Bronchoalveolar Lavage Fluid/chemistry , Bronchoalveolar Lavage Fluid/virology , COVID-19/immunology , COVID-19/transmission , COVID-19 Nucleic Acid Testing , COVID-19 Serological Testing , Female , Humans , Male , Middle Aged , SARS-CoV-2 , Tissue Donors , Young Adult
14.
Biomed Res Int ; 2020: 5703963, 2020.
Article in English | MEDLINE | ID: covidwho-878206

ABSTRACT

INTRODUCTION: SARS-CoV-2 is a virus that causes a potentially deadly syndrome that affects especially the respiratory tract. Kidney-transplanted patients are immunosuppressed and more susceptible to viral infections. We have examined our transplantation activity to explore the future role of kidney transplantation from deceased and living donors in COVID-19 era. Patients and Methods. The activity of our transplant center of Naples (one of the two transplant centers in Campania, South Italy) continued during the COVID-19 pandemic. We have analysed the kidney transplants carried out between March 9 and June 9, 2020, comparing these data with the numbers of procedures performed in the two previous years. Moreover, we have considered the possibility of performing living donor transplants during a worldwide pandemic. RESULTS: From March 9, 2020, when the Italian lockdown begun, till June 9, 2020, five kidney transplants have been performed at our transplant center in Naples, all from deceased donors. The donors and the recipients have been screened for COVID-19 infection, and the patients, all asymptomatic, followed strict preventive measures and were fully informed about the risks of surgery and immunosuppression during a pandemic. All the transplanted patients remained COVID negative during the follow-up. The number of transplants performed has been constant compared to the same months of 2018 and 2019. In agreement with the patients, we decided to postpone living donor transplants to a period of greater control of the SARS-CoV-2 spread in Italy. CONCLUSION: Deceased donor kidney transplantation should continue, especially in a region with moderate risk, like Campania, with a more careful selection of donors and recipients, preferring standard donors and recipients without severe comorbidities. Living donor transplantation program, instead, should be postponed to a period of greater control of the SARS-CoV-2 spread, as it is an elective surgery and its delay does not determine additional risks for patients.


Subject(s)
COVID-19/epidemiology , Kidney Transplantation/statistics & numerical data , COVID-19/diagnosis , COVID-19/prevention & control , Female , Humans , Italy/epidemiology , Kidney Transplantation/psychology , Living Donors/psychology , Living Donors/statistics & numerical data , Male , Middle Aged , Risk Factors , SARS-CoV-2/isolation & purification
15.
Trials ; 21(1): 499, 2020 06 08.
Article in English | MEDLINE | ID: covidwho-768581

ABSTRACT

OBJECTIVES: The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection. TRIAL DESIGN: This is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor. PARTICIPANTS: Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so. Exclusion criteria include participation in another clinical trial of anti-viral agent(s)* for coronavirus disease-2019 (COVID-19), receipt of any anti-viral agent(s)* with possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) for ≥ 5 days, severe multi-organ failure, history of allergic reactions to transfused blood products per NHSN/CDC criteria, known IgA deficiency, and pregnancy. Included participants will be hospitalized at the time of randomization and plasma infusion. *Use of remdesivir as treatment for COVID-19 is permitted. The study will be undertaken at Columbia University Irving Medical Center in New York, USA. INTERVENTION AND COMPARATOR: The investigational treatment is anti-SARS-CoV-2 human convalescent plasma. To procure the investigational treatment, volunteers who recovered from COVID-19 will undergo testing to confirm the presence of anti-SARS-CoV-2 antibody to the spike trimer at a 1:400 dilution. Donors will also be screened for transfusion-transmitted infections (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T. cruzi, ZIKV). If donors have experienced COVID-19 symptoms within 28 days, they will be screened with a nasopharyngeal swab to confirm they are SARS-CoV-2 PCR-negative. Plasma will be collected using standard apheresis technology by the New York Blood Center. Study participants will be randomized in a 2:1 ratio to receive one unit (200 - 250 mL) of anti-SARS-CoV-2 plasma versus one unit (200 - 250 mL) of the earliest available control plasma. The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. MAIN OUTCOMES: The primary endpoint is time to clinical improvement. This is defined as time from randomization to either discharge from the hospital or improvement by one point on the following seven-point ordinal scale, whichever occurs first. 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death This scale, designed to assess clinical status over time, was based on that recommended by the World Health Organization for use in determining efficacy end-points in clinical trials in hospitalized patients with COVID-19. A recent clinical trial evaluating the efficacy and safety of lopinavir- ritonavir for patients hospitalized with severe COVID-19 used a similar ordinal scale, as have recent clinical trials of novel therapeutics for severe influenza, including a post-hoc analysis of a trial evaluating immune plasma. The primary safety endpoints are cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events during the study period. RANDOMIZATION: Study participants will be randomized in a 2:1 ratio to receive anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform. Treatment assignments will be generated using randomly permuted blocks of different sizes to minimize imbalance while also minimizing predictability. BLINDING (MASKING): The study participants and the clinicians who will evaluate post-treatment outcomes will be blinded to group assignment. The blood bank and the clinical research team will not be blinded to group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): We plan to enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm. Among the participants, we expect ~70% or n = 72 will achieve clinical improvement. This will yield an 80% power for a one-sided Wald test at 0.15 level of significance under the proportional hazards model with a hazard ratio of 1.5. TRIAL STATUS: Protocol AAAS9924, Version 17APR2020, 4/17/2020 Start of recruitment: April 20, 2020 Recruitment is ongoing. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04359810 Date of trial registration: April 24, 2020 Retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of 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/immunology , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Randomized Controlled Trials as Topic , Adult , Antibodies, Viral/blood , Antibodies, Viral/immunology , COVID-19 , Clinical Trials, Phase II as Topic , Humans , Immunization, Passive/adverse effects , Immunization, Passive/methods , Pandemics , Prospective Studies , SARS-CoV-2
16.
Clin Res Hepatol Gastroenterol ; 45(3): 101512, 2021 May.
Article in English | MEDLINE | ID: covidwho-696625

ABSTRACT

BACKGROUND: The COVID-19 pandemic is an emergency worldwide. In Italy, liver transplant activity was carried on, but despite all efforts, a 25% reduction of procured organs has already been observed during the first 4 weeks of the outbreak. AIMS: To analyze if our strategy and organization of LT pathway during the first two months of the COVID-19 emergency succeeded in keeping a high level of LT activity, comparing the number of LT in the first two months with the same period of time in 2019. METHODS: We compared the liver transplants performed in our Center between February 24th and April 17th, 2020 with liver transplants performed in the same period in 2019. RESULTS: In 2020, 21 patients underwent liver transplantation from deceased donors, exactly as the year before, without statistically significant difference. All patients survived in both groups, and the rate of early graft dysfunction was 24% in 2020 and 33% in 2019. In 2020 Median MELD was higher (17 vs 13). We were able to perform 3 multiorgan transplants and one acute liver failure. Nobody died on waiting list. The performance of our Center, despite the maxi-emergency situation, was steady and this was the result of a tremendous team working within the hospital and in our region. CONCLUSIONS: Team working allowed our Center to maintain its activity level, taking care of patients before and after liver transplantation. Sharing our experience, we hope to be helpful to other Centers that are facing the pandemic and, if another pandemic comes, to be more prepared to deal with it.


Subject(s)
COVID-19 , Liver Transplantation/statistics & numerical data , Aged , COVID-19/epidemiology , Cohort Studies , Female , Humans , Italy/epidemiology , Male , Middle Aged , Time Factors
18.
Transplant Direct ; 6(8): e582, 2020 Aug.
Article in English | MEDLINE | ID: covidwho-682463

ABSTRACT

The novel severe acute respiratory syndrome coronavirus 2 was identified in the late 2019 as the cause of coronavirus disease 2019 (COVID-19), an acute respiratory viral illness. Patients with chronic underlying conditions may have an increased risk of morbidity and mortality from COVID-19. Kidney transplant recipients may be at a uniquely increased risk of serious complications from COVID-19 as compared to the general population because of a chronically immunosuppressed state and a high prevalence of comorbidities like diabetes, heart disease, and lung disease. Early data suggest that the mortality of patients on dialysis may be comparable to those with kidney transplants, although more research is needed. This concise review aims to describe the epidemiology of COVID-19 in kidney transplant recipients, manifestations, appropriate management, and clinical outcomes based on the available literature. Current evidence on many of the specific antiviral measures against COVID-19 has not shown a clear-cut benefit in smaller studies and the results of several ongoing larger clinical trials are awaited. In addition, we also highlight the impact of COVID-19 on kidney transplant center practice and volumes; potential living or deceased donors, recipients; and induction immunosuppression and surgical strategies.

19.
Transplant Proc ; 52(9): 2578-2583, 2020 Nov.
Article in English | MEDLINE | ID: covidwho-680819

ABSTRACT

BACKGROUND: The coronavirus disease 2019 (COVID-19) outbreak has unfavorably influenced solid organ donation activity. AIM: The aim of this study is to investigate the effect of COVID-19 on transplantation in the North Italy Transplant program (NITp). MATERIAL AND METHODS: This cross-sectional study included all consecutive potential deceased donors proposed in the NITp in 6 weeks after February 21, 2020 (period A) compared to all potential donors during the same time frame of the previous years (period B) and all potential donors 6 weeks before February 20, 2020 (period C). RESULTS: Fifty-eight deceased donors were proposed during period A, 95 were proposed during period B, and 128 were proposed during period C. After the evaluation process, 32 of 58 (55.2%), 60 of 95 (63.2%), and 79 of 128 (61.7%) donors were used for organ donation in periods A, B, and C, respectively (P value = .595). We observed a 47% donation reduction in period A compared to period B and a 60% reduction compared to period C. There was a reduction of 44% and 59% in transplantation comparing period A with period B and period C, respectively. CONCLUSIONS: This study showed an important reduction of donations and transplants during the COVID-19 pandemic.


Subject(s)
Coronavirus Infections , Organ Transplantation/statistics & numerical data , Pandemics , Pneumonia, Viral , Tissue and Organ Procurement/statistics & numerical data , Betacoronavirus , COVID-19 , Cross-Sectional Studies , Humans , Italy/epidemiology , SARS-CoV-2
20.
Pediatr Transplant ; 24(8): e13816, 2020 12.
Article in English | MEDLINE | ID: covidwho-670328

ABSTRACT

Amidst the coronavirus (COVID-19) pandemic, the American Society for Transplant Surgeons has recommended that only urgent liver transplant with deceased donors should occur. However, young pediatric candidates rely on living donors for lifesaving transplant. We present a case of non-directed left lateral lobe living liver donor transplant for a 7-month-old child with biliary atresia experiencing repeated life-threatening episodes of sepsis and cholangitis from infected bile lakes. Using careful preoperative planning among the entire multidisciplinary team, paying meticulous attention to infection control pre- and post-operatively, and taking advantage of robust telehealth technology both in and out of the hospital, a successful transplant was achieved. Amidst the COVID pandemic, non-directed liver transplantation can be safely achieved for pediatric recipients.


Subject(s)
Biliary Atresia/surgery , COVID-19 , Liver Transplantation , Female , Humans , Infant , Living Donors , Remission Induction , Tissue and Organ Procurement , Treatment Outcome
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