COVID-19 Updates

Information about COVID-19 (Coronavirus) is being released rapidly. We are posting updates here as we get them.

Regulatory updates

 

These recommendations have been updated as of July 31, 2020. Please contact Jennifer@RestoreSight.org with questions.

July 31, 2020

DONOR ELIGIBILITY

GUIDANCE RATIONALE

The EBAA Policy & Position Review Subcommittee of the Medical Advisory Board continues to update guidance and screening recommendations as the COVID-19 pandemic continues to evolve rapidly. Developments in our understanding of this novel SARS-CoV-2 virus and in our ability to screen donors should allow for the continued provision of safe corneal tissue to patients during this time. As we again proceed with elective corneal transplantation procedures across the US, the safety of corneal tissue may be supported by the following:

  1. There have been no reported cases of transmission of SARS-CoV-2, MERS-CoV, or any other coronavirus via transplantation of ocular tissue. A recent study reported that no SARS-CoV-2-RNA was detected in the cornea, conjunctiva or aqueous humor of five COVID-19 positive postmortem donors.1
  2. Current Medical Standards of the EBAA requires use of a double povidone iodine donor prep; povidone iodine has documented in vitro viricidal activity against coronaviruses.
  3. Increased testing of patients in the hospital and outpatient settings for COVID-19, and greater understanding of COVID-19 symptoms will enhance donor screening and the safety of donor tissue.
  4. Medical Director review for final determination of donor eligibility in certain cases allows for further assessment of the full clinical picture and/or case specific scenarios.
  5. Donor eligibility criteria remain fluid and complex during the COVID-19 pandemic. Current guidance is more clearly presented in table format for use by Eye Banks and Medical Directors.

DONOR TESTING

At this time, the EBAA is not requiring eye banks to perform post-mortem nasopharyngeal (NP) RT-PCR testing for SARS-CoV-2. However, a negative PCR result may be necessary (in addition to a Medical Director Review) to release certain tissue (see Donor Eligibility Table).  The decision to not require post-mortem NP RT-PCR testing for SARS-CoV-2 is based on several considerations including the variable false negative rates of current RT-PCR testing, ranging between 2-22%. Additionally, diagnostic RT-PCR tests for SARS-CoV have not been validated for cadaveric donors and are not intended for donor screening. Currently, the FDA does not recommend the use of laboratory tests to screen asymptomatic tissue donors.2

The EBAA acknowledges that other associations, hospital systems, eye banks, departments of health, or governments may require that all donors be tested for COVID-19.  Eye banks must establish a protocol to ensure access to testing notification and results obtained by partner agencies.  Results of such testing must be communicated to end-users on Tissue Report Forms or other supporting documents.

Eye banks may consider post-mortem testing of donors using currently available nasopharyngeal (NP) RT-PCR testing for SARS-CoV-2.  Again, these tests have not been validated for cadaveric samples. If testing is performed, results must be obtained prior to release for transplantation and reported to end-users on Tissue Report Forms or other support documents. Tissue from donors with indeterminant, invalid, or inconclusive results should not be released for transplant. SARS-CoV-2 testing may reduce, but does not eliminate, the potential of transplanting tissue from a donor with COVID-19. Post-mortem testing must be performed within 24 hours of death. Considerations that may help guide the decision to initiate widespread donor testing should include epidemiologic factors such as the prevalence of disease within the recovery area, and the availability of supplies (e.g. swabs, viral transport media, reagents, etc.).

Finally, the EBAA does not suggest serologic testing for COVID-19 antibodies. Viral RNA can still be detected in patients despite development of antibodies against SARS-CoV-2.3,4

DONOR PREP

A recently published review2 looked at the persistence of coronaviruses on inanimate surfaces as well as their inactivation with biocidal agents. Their review of the literature found that povidone iodine (0.23 – 7.5%) readily inactivated coronavirus (SARS-CoV and MERS-CoV) infectivity by approximately 4 log10 or more in vitro, with exposure times ranging between 15 seconds and 1 minute. Although we must be careful to extrapolate too much from these findings to the novel coronavirus, SARS-CoV-2, these results certainly support the current EBAA standards for ocular surface prep prior to recovery.

The European Centre for Disease Prevention and Control (ECDC) considers this a disinfection or microbial inactivation step that is validated for enveloped viruses. However, it is not known if infectious virus particles are present inside ocular surface cells or within deeper layers of the ocular tissue that may or may not be eliminated by povidone-iodine preparations.

REFERENCES

1Bayyoud T, Iftner A, Iftner T, et al. Absence of Severe Acute Respiratory Syndrome-Coronavirus-2 RNA in Human Corneal Tissues. Cornea. 2020 Jun 29 (published online ahead of print).

2Kampf G, Todt D, Pfaender S, et al. Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. J Hosp Infection. 2020 Mar;104(3):246-251.

3Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the Coronavirus Disease 2019 Pandemic”. US Food & Drug Administration, US Department of Health & Human Services, 2 July 2020, https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/updated-information-human-cell-tissue-or-cellular-or-tissue-based-product-hctp-establishments.

4To KK, Tsang OT, Leung WS, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 Mar 23. doi: 10.1016/S1473-3099(20)30196-1.

5Zhao J, Yuan Q, Wang H, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. 2020 Mar 28. doi: 10.1093/cid/ciaa344.

July 7, 2020

FDA continues to closely monitor the COVID-19 pandemic and has released updated information for HCT/P establishments. Respiratory viruses, in general, are not known to be transmitted by implantation, transplantation, infusion, or transfer of human cells, tissues, or cellular or tissue-based products (HCT/Ps). To date, there have been no reported cases of transmission of COVID-19 via these products.

Routine screening measures are already in place for evaluating clinical evidence of infection in HCT/P donors. FDA is aware that some HCT/P establishments in the U.S. are considering additional donor screening and testing measures in response to the COVID-19 pandemic.

FDA does not recommend using laboratory tests to screen asymptomatic HCT/P donors.

The HCT/P establishment’s responsible person must determine and document the eligibility of a cell or tissue donor (21 CFR 1271.50). Based on information available at this time, establishments may wish to consider, whether, in the 28 days prior to HCT/P recovery, the donor:

  • cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection; or
  • had been diagnosed with or suspected of having COVID-19 infection; or
  • had a positive diagnostic test (e.g., nasopharyngeal swab) for SARS-CoV-2 but never developed symptoms.

New Study Shows Absence of SARS-CoV-2 RNA in Human Corneal Tissues

A pre-publication study in Cornea showed the absence the SARS-CoV-2 viral RNA in corneal tissues obtained from COVID-19 postmortem donors using quantitative (q)RT-PCR-testing. The study was undertaken to examine corneal tissue for SARS-CoV-2 positivity with regard to implications for tissue procurement, processing, corneal transplantation.

German researchers performed (q)RT-PCR-testing on corneal stroma and endothelium, bulbar conjunctiva, conjunctival fluid swabs, anterior chamber fluid and corneal epithelium from 5 patients who expired from COVID-19 with ARDS and multiorgan dysfunction.

In this study no SARS-CoV-2-RNA was detected in conjunctiva, anterior chamber fluid and corneal tissues (endothelium, stroma and epithelium) of COVID-19 donors. This implicates that the risk for SARS-CoV-2 infection via corneal or conjunctival tissue is very low. However, further studies on a higher number of COVID-19 patients are necessary to confirm these results.

 

May 14, 2020

The EBAA Policy & Position Review Subcommittee of the Medical Advisory Board continues to update guidance and screening recommendations as the COVID-19 pandemic continues to evolve rapidly. Developments in our understanding of this novel SARS-CoV-2 virus and in our ability to screen donors should allow for the continued provision of safe corneal tissue to patients during this time. As we again proceed with elective corneal transplantation procedures across the US, the safety of corneal tissue may be supported by the following:

  1. There have been no reported cases of transmission of SARS-CoV, MERS-CoV, or any other coronavirus via transplantation of ocular tissue.
  2. Current Medical Standards of the EBAA requires use of a double povidone iodine donor prep; povidone iodine has documented in vitro viricidal activity against coronaviruses.
  3. Increased testing of patients in the hospital and outpatient settings for SARS-CoV-2, and greater understanding of COVID-19 symptoms will enhance donor screening and the safety of donor tissue.
  4. Medical Director review for final determination of donor eligibility in certain cases allows for further assessment of the full clinical picture and/or case specific scenarios.
  5. Donor eligibility criteria remain fluid and complex during the COVID-19 pandemic. Current guidance is more clearly presented in table format for use by eye banks and Medical Directors.

1RT-PCR SARS-CoV-2 test performed prior to or less than 24 hours after death.  If performed, but result is indeterminate or inconclusive, then donor should be deferred.

2Development of one of the following signs consistent with possible COVID-19 infection within the 28 days prior to death:

  • ARDS
  • Pneumonia
  • Pulmonary computed tomography (CT) showing “ground glass opacities” (regardless of whether another organism is present)

3Development of acute symptoms consistent with COVID-19 infection within the 28 days prior to death:

One of the following:

  • Cough
  • Shortness of breath/difficulty breathing

OR

Two of the following:

  • Fever
  • Chills
  • Repeated shaking with chills
  • Muscle Pain
  • Headache
  • Sore throat
  • New loss of taste or smell

4Close contact is defined by the CDC as:

  1. being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time; close contact can occur while caring for, living with, visiting, or sharing a health care waiting area or room with a COVID-19 case; OR
  2. having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).

   IF such contact occurs while not wearing recommended personal protective equipment (PPE).

DONOR TESTING
At this time, the EBAA is not requiring eye banks to perform post-mortem nasopharyngeal (NP) RT-PCR testing for SARS-CoV-2. However, a negative PCR result may be necessary (in addition to a Medical Director Review) to release certain tissue (see Donor Eligibility Table).  The decision to not require post-mortem NP RT-PCR testing for SARS-CoV-2 is based on several considerations including the variable false negative rates of current RT-PCR testing, ranging between 2-22%. Additionally, diagnostic RT-PCR tests for SARS-CoV have not been validated for cadaveric donors and are not intended for donor screening. Currently, the FDA does not recommend the use of laboratory tests to screen asymptomatic blood or plasma donors.5

The EBAA acknowledges that other associations, hospital systems, eye banks, departments of health, or governments may require that all donors be tested for COVID-19.  Eye banks need to establish a protocol to ensure access to testing notification and results obtained by partner agencies.  Results of such testing must be communicated to end-users on Tissue Report Forms or other supporting documents.

Eye banks may consider post-mortem testing of donors using currently available nasopharyngeal (NP) RT-PCR testing for SARS-CoV-2.  Again, these tests have not been validated for cadaveric samples. If testing is performed, results must be obtained prior to release for transplantation and reported to end-users on Tissue Report Forms or other support documents. Tissue from donors with indeterminant, invalid, or inconclusive results should not be released for transplant. SARS-CoV-2 testing may reduce, but does not eliminate, the potential of transplanting tissue from a donor with COVID-19. Post-mortem testing must be performed within 24 hours of death. Considerations that may help guide the decision to initiate wide-spread donor testing should include epidemiologic factors such as the prevalence of disease within the recovery area, and the availability of supplies (e.g. swabs, viral transport media, reagents, etc.).

Finally, the EBAA does not suggest serologic testing for COVID-19 antibodies. Viral RNA can still be detected in patients despite development of antibodies against SARS-CoV-2.6,7

DONOR PREP
A recently published review8 looked at the persistence of coronaviruses on inanimate surfaces as well as their inactivation with biocidal agents. Their review of the literature found that povidone iodine (0.23 – 7.5%) readily inactivated coronavirus (SARS-CoV and MERS-CoV) infectivity by approximately 4 log10 or more in vitro, with exposure times ranging between 15 seconds and 1 minute. Although we must be careful to extrapolate too much from these findings to the novel coronavirus, SARS-CoV-2, these results certainly support the current EBAA standards for ocular surface prep prior to recovery.

The European Centre for Disease Prevention and Control (ECDC) considers this a disinfection or microbial inactivation step that is validated for enveloped viruses. However, it is not known if infectious virus particles are present inside ocular surface cells or within deeper layers of the ocular tissue that may or may not be eliminated by povidone-iodine preparations.

5Kampf G, Todt D, Pfaender S, et al. Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. J Hosp Infection. 2020 Mar;104(3):246-251.

6Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the Coronavirus Disease 2019 Pandemic”. US Food & Drug Administration, US Department of Health & Human Services, 1 April 2020, https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/updated-information-human-cell-tissue-or-cellular-or-tissue-based-product-hctp-establishments.

7To KK, Tsang OT, Leung WS, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 Mar 23. doi: 10.1016/S1473-3099(20)30196-1.

8Zhao J, Yuan Q, Wang H, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. 2020 Mar 28. doi: 10.1093/cid/ciaa344.

 

April 29, 2020

The global case total climbed to 3,094,829 in 185 nations by Tuesday night, with fatalities reaching 215,461, according to the Johns Hopkins online dashboard. The US total is at 1,004,908 with 57,812 deaths.

Preliminary results from serologic surveys suggest that coronavirus infections greatly outnumber confirmed COVID-19 cases by a factor of 10 or more. Higher infection rates mean that there is a much lower infection fatality rate than the 6 percent case fatality rate seen globally and, in the U.S.,

COVID-19 Symptoms

The CDC added six new potential COVID-19 symptoms which typically appear 2-14 days after exposure. Originally listing only fever, cough and shortness of breath as coronavirus symptoms, the agency has now added chills, repeated shaking with chills, muscle pain, headache, sore throat and new loss of taste or smell.

Prolonged SARS-CoV-2 RNA Detection from Ocular Sections

A single case report published in the Annals of Internal Medicine,has demonstrated presence of infectious SARS-CoV-2 virus and viral RNA  in the conjunctiva of a patient with a history of conjunctivitis up to 27 days. The first patient in Italy to be diagnosed with COVID-19 also had conjunctivitis in addition to fever and respiratory and gastrointestinal signs. RT-PCR on conjunctival swabs showed SARS-CoV-2 RNA from day 3 of hospitalization until day 21 (1 day after the conjunctivitis resolved), and again at day 27, at which point nasal swabs were negative. Infectious virus was isolated by cell culture from a sample taken on day 3.

https://annals.org/aim/fullarticle/2764963/sars-cov-2-isolation-from-ocular-secretions-patient-covid-19

Povidone-Iodine and COVID-19

A recent review about the persistence of coronaviruses on inanimate surfaces, as well as their inactivation with biocidal agents revealed that povidone iodine (0.23 – 7.5%) readily inactivated coronavirus infectivity by approximately 4 log10or more, with exposure times of 15 seconds.

Current EBAA Medical Standard E1.100 Recovery procedures requiring double exposure of povidone-iodine to ocular tissue would result in rapid viricidal activity against coronaviruses and reduce the likelihood that COVID-19 may be transmitted through corneal transplantation.

The ocular surface is not an inanimate surface and it is not known if infectious virus particles inside ocular surface cells are eliminated by povidone iodine preparations. Nonetheless, the European Centre for Disease Prevention and Control (ECDC) considers this a disinfection or microbial inactivation step that is validated for enveloped viruses.

Latest Guidance and Publications on COVID-19:

The CDC has developed a new web page to provide summaries of hospitalization data due to COVID-19 in the U.S.  See the COVID-NET page.

Information for Healthcare Professionals

Clinical Care Guidance for Healthcare Professionals about COVID-19

Guidance for U.S. Healthcare Facilities about COVID-19

COVID-19 Infection Prevention and Control in Healthcare Settings: Questions and Answers

Hospitalization Rates and Characteristics of Patients Hospitalized with Laboratory-Confirmed Coronavirus Disease 2019 — COVID-NET, 14 States, March 1–30, 2020

Characteristics of Health Care Personnel with COVID-19 — United States, February 12–April 9, 2020. MMWR Morb Mortal Wkly Rep 2020; 69:477–481. DOI: http://dx.doi.org/10.15585/mmwr.mm6915e6

Kim D, Quinn J, Pinsky B, Shah NH, Brown I. Rates of Co-infection Between SARS-CoV-2 and Other Respiratory Pathogens. JAMA. Published online April 15, 2020. doi:10.1001/jama.2020.6266   https://jamanetwork.com/journals/jama/fullarticle/2764787

Richardson S, Hirsch JS, Narasimhan M, et al. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. Published online April 22, 2020. doi:10.1001/jama.2020.6775 https://jamanetwork.com/journals/jama/fullarticle/2765184

Chow EJ, Schwartz NG, Tobolowsky FA, et al. Symptom Screening at Illness Onset of Health Care Personnel With SARS-CoV-2 Infection in King County, Washington. JAMA. Published online April 17, 2020. doi:10.1001/jama.2020.6637 https://jamanetwork.com/journals/jama/fullarticle/2764953

Chen L, Liu M, Zhang Z, et al.Ocular manifestations of a hospitalised patient with confirmed 2019 novel coronavirus disease. British Journal of Ophthalmology Published Online First: 07 April 2020. doi: 10.1136/bjophthalmol-2020-316304 https://bjo.bmj.com/content/early/2020/04/07/bjophthalmol-2020-316304

 

 

April 14, 2020

COVID-19 Updated Guidance and Screening Recommendations

1  Tissue from a patient who has tested negative for COVID-19 by any of the available testing methods AND has another etiology which explains the symptoms and/or findings, may be considered for transplant use with Medical Director approval.

2   Close contact is defined as: a) being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time; close contact can occur while caring for, living with, visiting, or sharing a health care waiting area or room with a COVID-19 case; or b) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).

 

 

April 2, 2020

The Food and Drug Administration (FDA) shared updated information for human cells, tissues, or cellular or tissue-based products (HCT/P) establishments regarding the Cornonavirus-19 2019 Pandemic.

 

March 30, 2020

President Trump extends social distancing guidance until April 30

 

March 19, 2020

CMS releases Elective Surgery Recommendations during the COVID-19 pandemic, recommending that elective surgeries and non-essential medical and surgical procedures should be delayed to conserve critical resources and limit exposure of patients and staff to SARS-CoV-2 virus.

CDC published the first description of outcomes among patients with COVID-19 in the United States.

 

March 17, 2020

EBAA continues to closely monitor the outbreak of respiratory disease

 

March 9, 2020

CDC Releases Updated Guidance on Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19)

 

March 2, 2020

EBAA has released updated COVID-19 Screening Recommendations for EBAA Member Eye Banks.

 

February 28, 2020

 

February 27, 2020

 

February 25, 2020:

Updated Travel Advisories from CDC:

Level 3 Travel Health Notice for Coronavirus in South Korea.
Level 2 Travel Health Notices for Coronavirus in Italy and Iran.

 

February 24, 2020:

 

February 21, 2020

CDC has issued a level 1 travel notice for Japan because of coronavirus.

 

February 19, 2020

CDC issued a travel notice for Hong Kong associated with COVID-19. Defer any donor who has traveled to mainland China or Hong Kong in the past 28 days.

 

February 18, 2020

The Food and Drug Administration (FDA)

 

February 17, 2020:

 

February 11, 2020

On February 11, 2020