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Table of Contents
SPECIAL ARTICLE
Year : 2022  |  Volume : 16  |  Issue : 1  |  Page : 8-16

Consensus statement on organ donation from COVID-positive deceased donors-Indian Society of Organ Transplantation, Liver Transplant Society of India and Indian Society for Heart and Lung Transplantation


1 Hepatobiliary Surgery and Liver Transplantation, Aster CMI Hospital, Bengaluru, Karnataka; Liver Transplant Society of India, India
2 Institute of Kidney Diseases and Research Center and Dr. H L Trivedi Institute of Transplantation Sciences (IKDRC-ITS), Ahmedabad, Gujarat, India
3 KIMS Hospital, Hyderabad, Telangana, India
4 Liver Transplant Society of India; Department Hepatobiliary Surgery and Liver Transplantation, HN Reliance Hospital, Mumbai, Maharashtra, India
5 Department of Nephrology, Osmania Medical College and Osmania General Hospital, Hyderabad, Telangana, India
6 Department of Intensive Care, Aster RV Hospital, Bengaluru, Karnataka, India
7 Aster CMI Hospital, Bengaluru, Karnataka, India
8 Department of Urology, GSMC and KEMH, Parel, Mumbai, Maharashtra, India
9 Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
10 Division of Renal Transplantation, Indraprastha Apollo Hospital, New Delhi, India
11 Department of Nephrology, Medanta Hospital, Gurugram, Haryana, India
12 Department of Nephrology, IPGMER, Kolkata, West Bengal, India
13 Renal Transplant Programme, Narayana Health (RTIICS), Kolkata, West Bengal; Indian Society of Organ Transplantation, India
14 Department of Urology, Government Medical College and SSH, Nagpur, Maharashtra, India
15 Fortis Hospitals, Delhi, India
16 Department of Cardiology, AIIMS, New Delhi, India
17 Department of Nephrology, AIIMS, New Delhi, India
18 Indian Society of Organ Transplantation; Apex Hospital, Varanasi, Uttar Pradesh, India
19 Department of Nephrology, Primus Hospital, New Delhi, India
20 Indian Society of Organ Transplantation and Consultant, Madras Medical Mission Hospital, Chennai, Tamil Nadu, India

Date of Submission26-Feb-2022
Date of Acceptance03-Mar-2022
Date of Web Publication31-Mar-2022

Correspondence Address:
Dr. Sunil Shroff
Department of Urology, Sri Ramachandra Medical College Chennai, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijot.ijot_29_22

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  Abstract 


COVID has drastically impacted organ donation across the world, leading to untold misery for thousands of patients who have been waiting for organs. Early rules on the use of organs from COVID positive or affected donors were stringent due to the fear of spread of disease or thrombotic complications in patients who received these organs. However much has changed in the past two years. Most of our adult population has either been infected with COVID, or has received two doses of vaccine, or both. The current variant, despite being more infective, is associated with mild disease, especially in those who have been vaccinated Our armamentarium against severe COVID has improved dramatically in the past year- we have effective vaccines, monoclonal antibodies for treatment of mild COVID in high risk patients and post exposure and antiviral prophylaxis and treatment which can substantially reduce the risk of severe COVID requiring ICU admission. The risk of transmission of COVID infection has to be balanced against the risk of patients dying with end organ disease. We will have to learn to live with COVID- this also means investigating whether organs from donors who are, or have been COVID positive can be used with acceptable risk –benefit in selected patients with end stage organ failure. This document is a summary of evidence and information regarding donor screening for SARS-CoV-2 and considerations for organ acceptance from donors with a history of COVID-19.

Keywords: COVID-19, endstage organ failure, organ donation, pandemic, severe acute respiratory syndrome coronavirus 2, transplantation


How to cite this article:
Asthana S, Kute V, Shah U, Mohanka R, Sahay M, Chinnadurai R, Rajagopal S, Patwardhan S, Prasad N, Guleria S, Bansal S, Choudhary AR, Ray DS, Kolte S, Gulati S, Seth S, Agarwal SK, Ojha JP, Varma P P, Shroff S. Consensus statement on organ donation from COVID-positive deceased donors-Indian Society of Organ Transplantation, Liver Transplant Society of India and Indian Society for Heart and Lung Transplantation. Indian J Transplant 2022;16:8-16

How to cite this URL:
Asthana S, Kute V, Shah U, Mohanka R, Sahay M, Chinnadurai R, Rajagopal S, Patwardhan S, Prasad N, Guleria S, Bansal S, Choudhary AR, Ray DS, Kolte S, Gulati S, Seth S, Agarwal SK, Ojha JP, Varma P P, Shroff S. Consensus statement on organ donation from COVID-positive deceased donors-Indian Society of Organ Transplantation, Liver Transplant Society of India and Indian Society for Heart and Lung Transplantation. Indian J Transplant [serial online] 2022 [cited 2022 Jul 1];16:8-16. Available from: https://www.ijtonline.in/text.asp?2022/16/1/8/342434




  Background Top


The COVID-19 pandemic has drastically impacted organ donation across the world, leading to untold misery for thousands of patients who have been waiting for organs. Several guidelines and consensus statements have been published by professional societies and the National Organ and Tissue Transplant Organization (NOTTO), Government of India for organ donation and transplantation during the COVID-19 pandemic, vaccination, vaccine-induced thrombotic thrombocytopenia. Early rules on the use of organs from COVID-19 positive or affected donors were restrictive and stringent due to the fear of the spread of disease or thrombotic complications in patients who received these organs.

The toll on patients with end-stage organ failure has been horrific-estimated numbers of life-years lost were 37,664 years for patients waitlisted for a kidney, 7,370 years for patients waitlisted for a liver, 1,799 years for patients waitlisted for a lung, and 1,406 for patients waitlisted for a heart, corresponding to a total of 48,239 life-years, between 2019 and 2020.[1] This pandemic has significantly reduced organ donation and transplantation in India too, with 12,666 total organ transplants in 2019 compared to 7,443 in 2020 and a 50% decline in deceased donor transplants.

The current surge/wave in India is driven by the Omicron variant, which despite being more transmissible, is associated with mild disease, especially in those who have been vaccinated. There is also evidence that viral carriage in Omicron is substantially lower than Delta, with most asymptomatic or mildly symptomatic individuals achieving clearance within 7–10 days.[2],[3] With most adult population having either been infected with COVID, or having received two doses of vaccine, or both, availability of monoclonal antibodies (mAb) and post exposure antiviral prophylaxis and treatment, the risk of severe COVID requiring intensive care unit (ICU) admission and mortality has been lesser, compared to previous waves.

A number of preliminary reports have found that organs from severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) positive donors can be safely utilized for selected solid organ transplants.[4],[5],[6] Since COVID-19 is entering the endemic phase in most countries, we will have to learn to live with COVID, and continue offering transplants to selected patients if the risk-benefit of donor-to-recipient SARS CoV-2 transmission and its influence on recipient mortality is acceptable compared to the risk due to their end-stage organ disease. We present a summary of available evidence provide guidelines to enable safe organ transplantation from SARS CoV-2 positive donors [Figure 1].
Figure 1: Sop for utilisation of organs from donors who test positive for SARS CoV-2

Click here to view



  Tests for Severe Acute Respiratory Syndrome Coronavirus 2 Top


Current guidelines suggest potential donors be tested for SARS CoV-2 using Real-Time Polymerase Chain Reaction (RT-PCR) or Nucleic acid test within 72 h before organ recovery, ideally as close to the recovery as possible. A RT-PCR can persistently remain positive for several weeks after infection or may represent a re-infection, especially if the interval between the initial infection and positivity is more than 90 days. Two negative RT-PCR tests may reduce false-negative results.

An endotracheal/bronchoalveolar lavage (BAL) specimen is recommended for intubated patients, although a lower respiratory BAL sample is recommended when recovery of lungs is planned. Viremia in the blood is extremely uncommon in asymptomatic patients-there have been no reports of transmission of SARS CoV-2 through blood transfusion.[7],[8] The virus may be detected in feces.[9] The current evidence does not support testing of nonairway samples for SARS CoV-2.[10]

Cycle threshold (CT) values reported with the RT-PCR test indicate the number of amplification cycles needed to achieve a positive result. A lower value has been used as a surrogate marker for the viral load, although they may have wide margins of error.[11] These values are also highly dependent on the manner and site of sample collection and are not comparable between different kits.

In accordance with the current Centers for Disease Control and Prevention (CDC) and Food and Drug Administration recommendations, using raw CT values reported in RT-PCR as an index of either infection or infectivity is not recommended.[12]

Chest CT scan of the donor is mandatory prior to lung transplantation and may also be required in other transplants for donor and/or recipient if suggested by the transplant team.

There have been three reported donor-derived transmissions to lung recipients[7] and current national guidelines do not recommend utilization of lungs from SARS CoV-2 positive donors for transplantation.

Viral ribonucleic acid (RNA) may be evaluated in organs or tissues using electron microscope (such as lung, kidney, and myocardium) as per available resources to strengthen the decision to proceed with transplant.

A positive quantitative SARS-CoV-2 spike protein antibody test suggests COVID-19 vaccine-induced protection and a positive quantitative SARS-CoV-2 spike receptor-binding domain antibody test suggests COVID-19 infection-induced protection. These could be a useful tool in the recipient to decide the safety of transplantation. Anti-nucleocapsid (Anti-N) antibody turns positive within 4 days of exposure and indicates recent exposure.[10] Anti-N antibody Immunoglobulin G (IgG) and IgM may be measured to look at recent or prior infection. Anti-N IgG and IgM are positive on average by day 5 post infection. It may be helpful in potential deceased donors who are persistently RT-PCR negative but have strong clinical symptoms, significant exposure history or presentation with non-respiratory symptoms such as diarrhea.

Currently, NOTTO, ISOT, UK, and aspartate transaminase (AST) guidelines do NOT recommend using recipient antibody titer testing before transplant as there is insufficient evidence to support its use to assess safety or potential transmission risk to recipients.


  Donor Assessment Top


Donors should be assessed for clinical symptoms, severity, and end-organ failure.

  • The date of onset should be recorded to assess the infective potential of the SARS CoV-2 positive donor since nearly all asymptomatic patients clear the virus within 7–9 days[2],[3]
  • COVID-specific symptoms/disease severity: should be assessed based on reported history and classified into
  • Severe (symptomatic, required oxygen supplementation)
  • Mild (mild symptoms, did not require oxygen)
  • Asymptomatic-incidentally detected positive on testing
  • Resolved COVID: Any patient with a proven history of COVID with symptoms, which have resolved, for more than 21 days from the date of onset of symptoms, is considered to have resolved COVID.


All potential donations from SARS CoV-2-positive donors should be discussed with the local infection control team to understand and minimize the risk of viral spread to the recipient, the operating and treating team. All donors should be diligently screened for overt or occult end-organ damage. Such organs should be treated as “marginal” or “extended criteria” and offered to potential recipients only if the risks of SARS CoV-2 transmission and associated mortality are lesser compared to potential complications on the waitlist. Donors with severe COVID-19 symptoms and systemic multi-organ involvement before progressing to brain death should be considered high risk, and donation should only be considered if there is no evidence of organ damage (assessed either by blood tests, imaging, or a biopsy). We do not recommend elective living donor organ transplant from a donor with active COVID-19 to a recipient with COVID-19.

A detailed donor history including but not limited to suggested proforma [Annexures 1 and 2] and use Organ Procurement and Transplantation Network (OPTN) and CDC summary [Table 1] for risk stratification of potential highly selected organ donor with COVID-19 and recipient.
Table 1: Organ Procurement and Transplantation Network summary of current evidence and information on donor SARSCoV- 2 testing and organ recovery from donors with a history of COVID-19

Click here to view



  Recipient Assessment Top


Recipients who have recovered from SARS CoV-2 infection can safely undergo transplantation.

All recipients should be doubly vaccinated; current evidence supports the administration of a third booster dose of vaccine when available.[13] Patients with end-organ failure tend to mount poor response to vaccines; disappointingly, this continues to be low in some patients despite second, third, and fourth vaccine doses. It may be reasonable to prefer the recipient vaccinated with 2 doses of COVID-19 and or booster dose if available over nonvaccinated recipient.

A systematic review and meta-analysis of 112 studies until January 11, 2022, reporting immunogenicity of COVID-19 vaccine among transplant patients involving 15,391 transplant patients and 2844 healthy controls showed a suboptimal humoral response compared to general population. The response was highest in liver followed by heart, kidney, kidney-pancreas, and lung. Booster doses showed a marginal increase in efficacy. Transplant patients with prior infection had a higher response. The sero-response with Messenger (mRNA)-12,723 mRNA was the highest. Immunosuppression including mycophenolic acid, belatacept, and tacrolimus was associated with decreased response. We recommend that transplant recipients, their household members and transplant team health care workers should be vaccinated with ANY coronavirus vaccine that is authorized and approved for use by the local health authority.

COVID-19 vaccine efficacy wanes over time, especially against severe disease. As Omicron cases rise around the world, India announced COVID-19 vaccination for children aged 15–18 years and “precautionary (booster) doses” for healthcare and frontline workers, people above 60 years of age with comorbidities. In several countries, booster dose is also recommended for immunosuppressed and transplanted patients. Concurrent with guidelines from The Transplantation Society, CDC, American Society of Transplantation, National Health Service, the United Kingdom, and Joint Committee On Vaccination and Immunization, we suggest booster dose for transplant patients. Decreasing the gap between booster dosing, heterologous vaccine schedule, choosing higher potency COVID-19 vaccine, increased dose of COVID-19 vaccine, or regular interval dosing need further exploration for implementation.

The current UK and AST guidelines do not recommend testing for antibody titers before transplant, although high antibody levels may be protective against SARS CoV-2 re-infection.[14]

Current guidelines do not support offering transplant to recipients with active COVID infection or SARS CoV-2 positivity.

Case reports of recipients incidentally testing SARS CoV-2 positive in the peri or posttransplant period do not seem to have worse outcomes, although large studies are awaited.[15]

”Marginal” or “high risk” consent should be Taken from all recipients of SOT from CoVID + donors. Indications may include Acute Liver failure, Acute on chronic liver failure, high MELD patient, long wait time on dialysis, poor vascular access, patients on extracorporeal membrane oxygenation, or clinical urgency as identified by the treating team. The high-risk consent form should be shared with allocation body and should cover:

  • Risks of COVID transmission
  • Risks of severe COVID posttransplant due to immunosuppression
  • Risks of thrombotic complications
  • Current unknown long-term outcomes from donors with active COVID-19 and allograft quality.


Postexposure prophylaxis

mAb have been recommended for passive immunoprophylaxis of high-risk, immunocompromised and transplant patients. In December 2021, the American Society of Transplantation recognized anti-spike seronegativity as a consideration for use of monoclonal antibody pre-exposure prophylaxis. Early treatment (or post-exposure prophylaxis) with mAb, especially among those who are seronegative, significantly reduces serious COVID-19 in general population and may potentially reduce severe COVID-19 in transplant recipients too, although the Omicron variant may not be susceptible to these, including tixagevimab plus cilgavimab,[16] though sotrovimab (Vir/GSK, Xevudy®) appears to maintain high activity.[17]

The current pandemic in India is primarily driven by the Omicron variant, but significant regional variations exist.[18] Monoclonal antibody-based post exposure prophylaxis may be considered in patients with low antibody levels, and in geographies where the Delta variant still predominates. Genomic sequencing should be done if possible to help guide decisions on posttransplant monoclonal antibody therapy.

Based on currently available limited data, we suggest early treatment (or postexposure immunoprophylaxis) with mAb especially among seronegative SOT recipients to reduce serious severe COVID-19 in SOT recipients.

Paxlovid (Nirmatrelvir 300 mg with ritonavir 100 mg) for 5 days may be effective against Omicron variant too. Remdesivir and oral Molnupiravir may be other options for Omicron. Currently, antiviral therapy is not recommended for postexposure prophylaxis.


  General Recommendations for Transplant Top


Standard drugs and doses of induction and maintenance immunosuppressive regimen based on the recipient's immune risk stratification as was being practiced before COVID-19 may be reasonable, except in cases of inadvertent transplantation with active SARS-CoV-2. However, many programs preferentially omit induction immunosuppression or use a nondepleting form of induction in recipients either suspected of or confirmed to have COVID-19 infection. Available reports are predominantly in kidney transplant recipients, and more data for other organ transplants are needed.

Full personal protective equipment and COVID-19 appropriate behavior should be followed by transplant team to mitigate spread of infection. This will also prevent infection spread from asymptomatic health care workers to transplant recipients and hospital-acquired COVID-19 in perioperative period.[19]


  Summary of Data and Recommendations for Organ Transplants from Asymptomatic Severe Acute Respiratory Syndrome Coronavirus 2 Positive Donors Top


A review on safety of use of organs from SARS-CoV-2-infected donors identified 25 reports detailing 94 recipients of both abdominal and thoracic transplants from donors with both prior and active COVID-19 infection. Transplantation of abdominal or thoracic organs from donors with prior COVID-19 infection did not result in SARS-CoV-2 transmission to the recipient, when organs were accepted from highly selected donors, excluding severe COVID-19. End organ dysfunction and transmission were more common from donors with active infection, although few reports were available. Transplantation may be feasible and safe in the short term from carefully selected living and deceased donor with resolved COVID-19, even in carefully selected recipients with resolved COVID-19. However, the donor and recipient characteristics are variable in different studies and long-term outcomes are unknown.

Another comprehensive review of transplantation in SARS-CoV-2 recovered transplant candidates described 44 reports comprising 183 transplants (Kidney = 115; Lung = 27; Liver = 36; Heart = 3; simultaneous-pancreas-kidney = 1, small bowel = 1) using standard immunosuppression regimen found good outcomes in the short-term.

Another report of 178 nonlung organ transplants from May 27 to November 30, 2021, from donors with a positive lower respiratory tract SARS-CoV-2 test found good outcomes. We suggest emergency transplant can be performed from highly selected deceased donor with active SARS-CoV-2 infection in highly selected recipient after informed consent and risk-benefit evaluation by the expert committee [Annexures 1 and 2].

Renal transplantation from Severe Acute Respiratory Syndrome Coronavirus 2 positive deceased donors

Ten kidneys were transplanted from 5 asymptomatic deceased donors who incidentally tested positive for SARS-CoV-2 by RT-PCR within 3 days of donation. All recipients received standard induction immunosuppression, and there was no evidence of disease transmission or adverse allograft outcomes in 8–16 weeks of follow-up.[20]

COVID infection is also known to cause acute kidney injury. Kidneys from SARS-CoV-2 positive donors should be treated as marginal organs and allocated to patients whose risk of waiting exceeds the risk of infection, such as patients with precarious vascular access.

Renal transplant from Severe Acute Respiratory Syndrome Coronavirus 2 positive living donors

Current guidelines DO NOT support living donation from a potential donor diagnosed with SRS CoV-2 for 4 weeks from diagnosis. Severe symptomatic COVID-19 infection in the past could also be a relative contraindication.

Liver transplant from Severe Acute Respiratory Syndrome Coronavirus 2 positive deceased donors

Patients waiting for liver transplantation are at a substantial risk of mortality. There is no effective bridging modality comparable to dialysis in these patients. Acute liver failure is a dramatic and rapidly fatal condition where urgent transplantation becomes necessary.

An Italian multicenter study reported ten patients who received livers from SARS-CoV-2 positive donors. All donors' liver biopsies were negative for SARS-CoV-2 RNA, suggesting very low risk of transmission. There was no evidence of SARS-CoV-2 infection in the recipients. Two recipients had a positive molecular test at transplants and one of them remained positive for 21 days. None of the other 8 recipients got infected. SARS-CoV-2 IgG was positive in 80% of recipients, and 71% (5/7) showed neutralizing antibodies, expression of protective immunity related to recent COVID-19. The immunosuppression regimen remained unchanged, with adoption of a standard posttransplant protocol.[21]

A 14-year-old deceased donor with normal liver function had an incidental nasopharyngeal swab SARS-CoV-2 positive, with a positive household contact. Three days after admission, his nasopharyngeal swab, bronchi alveolar lavage, and tracheal aspirate RT-PCRs were negative and Anti-N and Anti-spike IGG were positive. The recipient of his liver had normal graft function.[22]

Current evidence suggests that livers from potential deceased donors who are SARS CoV-2 positive can be safely utilized in selected high-risk recipients with favorable early results.

Liver transplant from a severe acute respiratory syndrome coronavirus 2 positive living donor

A living donor transplant was performed between a SARS CoV-2-positive donor and a SARS CoV-2 positive recipient. Both did well, and the recipient tested negative 1 month after transplant.[14] However, current guidelines DO NOT support proceeding with a living liver donation for a potential donor who has recently diagnosed SRS CoV-2 positivity for a period of 4 weeks from diagnosis. History of severe symptomatic COVID infection in the past should also be a relative contraindication.

Heart transplant from severe acute respiratory syndrome coronavirus 2 positive deceased donors

Five heart transplants were reported from SARS CoV-2-positive donors in a case series from OPTN Data, none of which reported SARS Cov-2 transmission to the recipient.

A small series from Spain reported two patients who received heart and liver transplants from deceased donors, without any transmission.[23],[24]

Current limited evidence suggests that heart grafts from potential deceased donors who are positive for SARS CoV-2 can be safely utilized in selected high-risk recipients with favorable early results.

Lung transplant from severe acute respiratory syndrome coronavirus 2 positive deceased donors

There have been case reports of donor-to-recipient transmission during lung transplantation where donor nasopharyngeal swabs were negative during retrieval, but BAL came back positive after implantation leading to mortality or severe graft dysfunction requiring mechanical ventilatory support.[7],[25] There is no literature for utilizing lungs from proven SARS-Cov-2 positive donors as lungs are the primary end-organ of damage.

(International Society for Heart and Lung Transplantation [ISHLT]) 2021 guidelines[26] recommends pretransplant COVID-19 donor assessment as follows:

  • Donors suffering from a clinical syndrome compatible with COVID-19, regardless of known exposure within the past 10 days and negative RT-PCR results, should be avoided (unless alternative diagnosis is made)
  • It recommends testing for SARS-CoV-2 RNA by nasopharyngeal, oropharyngeal swab, sputum, tracheal aspirate, bronchial wash, or BAL < 72 h before organ donation. It strongly recommends a deep respiratory specimen (bronchial wash, BAL, mini-BAL, or tracheal aspirate) for SARS-CoV-2 RNA for all lung donors
  • Recommends a thoracic CT scan as it may show signs of COVID-19 pneumonia even before the development of symptoms or positive PCR
  • Antigen test is not acceptable for donor evaluation
  • COVID-19 vaccination status of the donor does not alter these recommendations
  • In case of exposure to confirmed or suspected case of COVID19 within the past 10 days, lungs may be considered for transplant if the donor has been asymptomatic for >7 days since exposure, has at least one negative SARS-CoV-2 RT-PCR test from a lower respiratory sample within 24 h of transplant and a CT chest negative for pulmonary infection and the potential candidate has a high risk of mortality without organ transplantation
  • Donors with prior confirmed COVID-19 may be considered for transplant after clinical resolution of symptoms due to COVID-19 after >21 days from onset of symptoms in an immunocompetent donor with no significant pulmonary disease due to COVID-19 (e.g., required intubation) and at least one negative SARS-CoV-2 PCR and CT scan of the chest negative for evidence of pulmonary infection/chronic lung injury.


ISHLT recommendations for recipients:

  • Recipients with exposure to confirmed or suspected case of COVID-19 within the past 10 days may be considered for transplant if they are asymptomatic for >7 days since exposure, have one negative SARS-CoV-2 RT-PCR test within 24 h prior to transplant, and high risk of mortality without transplantation. Otherwise, avoid cardiothoracic transplant within the 10-day incubation period.


    1. Recipients with previously symptomatic COVID-19 could be considered for transplant after clinical resolution for >21 days from onset of symptoms in an immunocompetent patient and a negative SARS-CoV-2 RT-PCR test
    2. Recipients with previous asymptomatic COVID-19 with positive SARS-CoV-2 RT-PCR may be considered for transplant after >14 days since diagnosis unless they have a high risk of mortality without transplantation and one negative SARS-CoV-2 PCR test within 72 h of transplant.


Acknowledgement

We express our thanks to Dr.Rajneesh Sahai, Director of National Organ and Tissue Transplant Organization (NOTTO) for his support and contribution during the webinar and for his encouragement to put up this consensus statement for publication.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.


  Annexure Top


Annexure 1: Potential organ donor with COVID-19 evaluation proforma at time of organ alert and during brain death evaluation

  • Name
  • National Organ and Tissue Transplant Organization/SOTTO ID number
  • Age in years
  • Gender: Male/female
  • Co-morbid conditions: Hypertension, diabetes, heart disease, cerebrovascular accident, and other




  • Vaccine-induced immune thrombotic thrombocytopenia yes/no
  • If yes clinical/laboratory-confirmed with platelet factor 4
  • Platelet count on declaration of brain death




  • SARS- CoV-2 real time polymerase chain reaction details




Possible persistent viral shedding yes/no

Organ quality tests

  • Assessment of clinical end organ dysfunction yes/no
  • Assessment of occult end organ dysfunction yes/no
  • Computerized tomography scan thorax with cycle threshold value and XR chest report
  • Organ frozen section report before allocation and zero hours report
  • Remark from donor management team for organ utility risk/benefit
  • Remark from harvesting team for organ utility risk/benefit


COVID-19 details



  • Past history of COVID-19 yes/no


    • If yes COVID-19 severity: asymptomatic, mild, moderate, and severe disease
    • Treatment: Indoor, home, intensive care unit


    • Admitted with COVID-19 symptoms: Yes/no
    • Date of onset of COVID-19 symptoms
    • Admitted with COVID-19-positive test yes/no date
    • If yes COVID-19 severity: Asymptomatic, mild, moderate, and severe disease
    • COVID-19 medication during treatment
    • COVID-19 complications/end-organ damage at time of brain death
    • COVID-19 inflammatory markers high/normal
    • Genetic sequence report: Delta/omicron
    • COVID-19 reactivation/re-infection
    • Outcome: Organ used for transplantation yes/no
    • Committee to decide case-by-case risk/benefit evaluation of COVID-19-positive organ for transplant






Annexure 2: Potential organ recipient from donor with COVID-19 pro forma

  • Name
  • National Organ and Tissue Transplant Organization/SOTTO ID number
  • Age in years
  • Gender: Male/female
  • Co-morbid conditions: Hypertension, diabetes, heart disease, cerebrovascular accident, and other






  • Need for monoclonal antibody treatment if quantitative SARS- CoV-2 antibody test against spike protein negative: Yes/no
  • SARS- CoV-2 real time polymerase chain reaction details




  • Computerized tomography scan thorax/XR chest report before transplant surgery


  • Past history of COVID-19 yes/no
  • If yes COVID-19 severity: asymptomatic, mild, moderate, and severe disease
  • Treatment: Indoor, home, intensive care unit
  • Patient and witness written consent including risk and benefit for organ transplant yes/no
  • Patient and witness video consent including risk and benefit for organ transplant yes/no
  • Ethics committee permission if required yes/no


Report appropriate state health authority and National Organ and Tissue Transplant Organization

  • COVID-19 clinical features after transplant yes/no
  • Routine discharge SARS- CoV-2 real-time polymerase chain reaction details: Positive/negative
  • Posttransplant COVID-19 positive in recipient




  • Computerized tomography scan thorax and XR chest report




 
  References Top

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Aubert O, Yoo D, Zielinski D, Cozzi E, Cardillo M, Dürr M, et al. COVID-19 pandemic and worldwide organ transplantation: A population-based study. Lancet Public Health 2021;6:e709-19.  Back to cited text no. 1
    
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Kates OS, Fisher CE, Rakita RM, Reyes JD, Limaye AP. Use of SARS-CoV-2-infected deceased organ donors: Should we always “just say no?” Am J Transplant 2020;20:1787-94.  Back to cited text no. 6
    
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Kaul DR, Valesano AL, Petrie JG, Sagana R, Lyu D, Lin J, et al. Donor to recipient transmission of SARS-CoV-2 by lung transplantation despite negative donor upper respiratory tract testing. Am J Transplant 2021;21:2885-9.  Back to cited text no. 7
    
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Valenti L, Pelusi S, Cherubini A, Bianco C, Ronzoni L, Uceda Renteria S, et al. Trends and risk factors of SARS-CoV-2 infection in asymptomatic blood donors. Transfusion 2021;61:3381-9.  Back to cited text no. 8
    
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Zhang Y, Cen M, Hu M, Du L, Hu W, Kim JJ, et al. Prevalence and persistent shedding of fecal SARS-CoV-2 RNA in patients with COVID-19 infection: A systematic review and meta-analysis. Clin Transl Gastroenterol 2021;12:e00343.  Back to cited text no. 9
    
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Porter WT, Kelley EJ, Bowers JR, Engelthaler DM. Normalization of SARS-CoV-2 viral load via RT-qPCR provides higher-resolution data for comparison across time and between patients. Virus Res 2021;306:198604.  Back to cited text no. 11
    
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Kute V, Meshram HS, Sharma A, Chaudhury AR, Sudhindran S, Gokhale AK, et al. Update on Coronavirus 2019 Vaccine Guidelines for Transplant Recipients. Transplant Proc 2021:S0041-1345(21)00683-7. Epub ahead of print.  Back to cited text no. 13
    
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Manzia TM, Gazia C, Lenci I, Angelico R, Toti L, Monaco A, et al. Liver transplantation performed in a SARS-CoV-2 positive hospitalized recipient using a SARS-CoV-2 infected donor. Am J Transplant 2021;21:2600-4.  Back to cited text no. 15
    
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Cao Y, Wang J, Jian F, Xiao T, Song W, Yisimayi A, et al. Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies. Nature 2022;602:657-63.  Back to cited text no. 16
    
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