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Coronavirus (COVID-19)

 


Have you been diagnosed with ITP? AND tested positive for COVID-19 OR been FULLY VACCINATED?

Your experience may hold the key to unlocking answers in determining if ITP patients have unique risks for adverse events. Participation is FREE, SECURE, CONFIDENTIAL (HIPAA compliant) and QUICK.

 

IT ALL STARTS WITH YOU

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COVID-19 & ITP SURVEY STATISTICS

Enrolled participants should visit itpstudy.org to return to surveys for completion or to include any relevant health updates.
For technical issues or additional questions, please contact PDSA Research Program Manager Jennifer DiRaimo, at jdiraimo@pdsa.org.

  • Survey FAQ's

    • Why Participate?

      These experiences can help us understand if these COVID-19 agents affect platelet counts and bleeding events, to determine if ITP patients have unique risks for adverse events.

    • What is the ITP Natural History Study Registry?

      The ITP Natural History Study Registry is an international patient-consented registry of individuals with ITP. The ITP Registry collects data on the natural progression of ITP, enabling PDSA to gather information on diagnosis and treatment, management of care, quality of life, and clinician reporting.

    • How is the Data Collected?

      Data is collected through a secure web-based system developed and overseen by the National Organization for Rare Disorders (NORD), a committee of leading hematologists, ITP patients and caregivers, and is administered by PDSA.
    • Is My Identity and Personal Information Safe?

      Yes, your identity will be protected in this confidential HIPAA (Health Insurance Portability and Accountability Act) compliant registry, following strict government guidelines to assure patient information is secure. The platform is served over HTTPS, which provides traffic encryptions so as to prevent eavesdropping and man-in-the-middle attacks. Communications between the registry platform application server and the database are also encrypted.
    • Where is Data Stored?

      The data is stored on NORD’s registry platform system which adheres to industry standards regarding security protections.
    • Who Owns the Data?

      The identifiable and de-identifiable data are owned by the study sponsor, the Platelet Disorder Support Association. PDSA decides how and with whom to share the data. A subset of the de-identified data collected across the NORD Registry Platform is available to NORD to support cross disease analysis and advocacy activities to members of the rare disease community as a whole.
    • Who Can Use the Data?

      One of the goals of the ITP Registry is to gather and disperse ITP and other platelet disorders information as quickly and securely as possible. In agreement with the standards set by NORD and the IRB, we plan to share de-identified data with any researcher who asks for it for a legitimate reason. The Platelet Disorder Support Association (PDSA) in collaboration with PDSA’s Patient Registry Advisory committee comprised of members of PDSA’s Medical Advisory Board, and ITP patients and caregivers, will review requests for access to de-identified data from researchers. Investigators wanting to use the registry or contact participants will need to apply to PDSA’s Patient Registry Advisory Committee. The Patient Registry Advisory Committee will review and approve applications based on study quality, potential, and value to ITP and other platelet disorders.
    • Is There a Cost to Participate?

      There is no cost to the patient or caregiver to join this study.
    • How Long Does It Take to Enroll?

      It takes 10-15 minutes to enroll and complete the COVID-19 & ITP Survey. Once enrolled, there is an opportunity to select which survey you want to complete. You may choose to complete only the COVID-19 & ITP survey and can return to it at any time for completion or to include any relevant health updates. You are encouraged to return, in your own timeframe, to complete additional surveys within the ITP Registry. These questionnaires collect information that helps us better understand ITP, advance research hypothesis, develop new treatments and standards of care, and may one day lead to a cure.
    • Technical Issues, Additional Questions?

      Contact PDSA Research Program Manager Jennifer DiRaimo, at jdiraimo@pdsa.org.


COVID-19 vaccines and ITP

  • 9/3/21 - COVID-19 VACCINE BOOSTER: Recommendations from the AMA and CDC

    What to tell immunocompromised patients about COVID-19 vaccines

    - From the American Medical Association

    Read Article

    COVID-19 Vaccines for Moderately to Severely Immunocompromised People

    - From the Centers for Disease Control and Prevention

    Read Article

  • 2/12/21 - COVID-19 VACCINE & ITP: Recommendations of the Medical Advisory Board of PDSA

    People Without Pre-existing Thrombocytopenia/ITP

    The occurrence of severe thrombocytopenia and death of a man in Florida after receiving the Pfizer COVID vaccine is tragic and concerning. However, the relationship between the occurrence of severe thrombocytopenia and the vaccination, if any, is uncertain despite the temporal proximity. This was the first of what is now over 15 cases that have been reported, consistent with increase in the number of people who have been vaccinated. It is not surprising that new cases of ITP continue to be recognized close to the time of vaccination just by chance given the very large number of individuals who have been vaccinated. As vaccinations continue to be given and additional vaccines are initiated, this is likely to continue to happen in the future. It is not possible at this time to know whether or not the timing of thrombocytopenia and vaccination were coincidental, if the vaccination was causal, or if vaccination led to an exacerbation of pre-existing unrecognized thrombocytopenia. Furthermore, some patients with ITP have had transient falls in their platelet counts after pneumococcal, MMR, and other vaccinations, so it would not be surprising to see similar transient platelet count changes following SARS-Cov2 vaccines as well.

    Based on all the available data, the medical advisory board believes at this time that the benefit to risk ratio strongly favors vaccination over avoiding vaccination for fear of thrombocytopenia of all eligible adults given the comparatively large number of effective and safe treatments of ITP that are available. This is true even for those perceived to be at low risk of serious illness with SARS-Cov2 infection. There is no clear profile that predicts who is more likely to develop thrombocytopenia. If a person is concerned because of a co-existing medical condition, they may wish to consult their physician. The medical advisory board would also recommend that anyone developing any bruising or bleeding symptoms obtain a blood count and have their management guided by a hematologist. Standard first line treatments of ITP, IVIG and steroids have been successful in most, but not all reported cases to date. To summarize, the medical advisory board of the Platelet Disorders Support Association believes at this time that the benefit to risk ratio strongly favors vaccination of all eligible adults.

    Pre-existing ITP

    For those with pre-existing ITP, it would seem prudent to consult with their hematologist and obtain a platelet count, if recommended, prior to vaccination as a baseline. If consulted, your hematologist may advise you as to whether and when your platelet count should be checked after the first and/or second vaccination in addition to the baseline value.

    It may be advisable for patients with bleeding disorders like ITP to take extra precautions when receiving the vaccine to prevent hematoma formation. If it is determined by a physician familiar with the patient that the bleeding risk of the patient’s ITP worsening is acceptable, then the vaccine can be administered intramuscularly with reasonable safety. The following technique is recommended: fine-gauge needle (23-gauge or smaller caliber) should be used for the vaccination, followed by firm pressure on the site, without rubbing, for at least 2 minutes.

    The medical board members also believe that as a community we need to continue to gather data on the effects of vaccination in patients with ITP. We encourage our ITP patients (and any people without pre-existing ITP) who develop thrombocytopenia after vaccination to notify PDSA regarding their own experiences with COVID vaccination, good or bad. We also encourage telling your physician of any adverse reactions for reporting to the federal database to inform the general community. PDSA will continue to provide updates about adverse effects relevant to the ITP community as information reaches us from the CDC, NIH, FDA MedWatch, and our collective clinical experience. We recognize that this is a very fluid situation and therefore recommendations may change frequently with additional experience.

    To summarize, the opinion of the medical advisors of PDSA is that our patients with ITP should not hesitate to be vaccinated based on all available information, but that individual patients may choose to consult with their hematologist or another physician before proceeding.

    More Commentary

  • 1/24/21 - Updated Statement on COVID Vaccine in ITP Patients from PDSA Medical Advisors

    The occurrence of severe thrombocytopenia and death of a man in Florida after receiving the Pfizer COVID vaccine is tragic and concerning. However, the relationship between the occurrence of severe thrombocytopenia and the vaccination, if any, is uncertain despite the temporal proximity. To the best of our knowledge, this is the first such event reported after well over 5 million such vaccinations. Two other new cases of ITP in adults were identified within two weeks of vaccination, but each of those individuals has recovered (or is recovering).

    It would not be surprising if some new cases of ITP are recognized close to the time of vaccination just by chance given the very large number of individuals who have been vaccinated. As vaccinations continue to be given and additional vaccines are initiated, this may likely happen again in the future. Thus, it is not possible at this time to know whether or not the vaccination was causal or coincidental. Furthermore, some patients with ITP have a transient fall in platelet count after pneumococcal, MMR, and other vaccinations so it would not be surprising to see transient platelet count changes following SARS-Cov2 vaccines as well.

    Based on all the available data, the medical advisory board believes at this time that the benefit to risk ratio strongly favors vaccination of all adults, including those with pre-existing ITP. We suggest that it might be prudent for patients with ITP to consult with their hematologist and obtain a platelet count, if recommended, prior to vaccination as a baseline. If consulted, your hematologist may advise you as to whether and when, your platelet count should be checked after the first or second vaccination in addition to the baseline value.

    It may be advisable for patients with bleeding disorders like ITP to take extra precautions when receiving the vaccine to prevent hematoma formation. If it is determined by a physician familiar with the patient that the bleeding risk of the patient’s ITP worsening is acceptable, then the vaccine can be administered intramuscularly with reasonable safety. The following technique is recommended: fine-gauge needle (23-gauge or smaller caliber) should be used for the vaccination, followed by firm pressure on the site, without rubbing, for at least 2 minutes.

    The medical board members also believe that as a community we need to continue to gather data on the effects of vaccination in patients with ITP. We encourage our ITP patients to notify PDSA regarding their own experiences with COVID vaccination, good or bad. We also encourage telling your physician of any adverse reactions for reporting to the federal database to inform the general community. PDSA will continue to provide updates about adverse effects relevant to the ITP community as information reaches us from the CDC, NIH, FDA MedWatch, and our collective clinical experience. We recognize that this is a very fluid situation and therefore recommendations may change with additional experience.

    To summarize, the opinion of the medical advisors of PDSA is that our patients with ITP should not hesitate to be vaccinated based on all available information, but that individual patients may choose to consult with their hematologist before proceeding.

  • 1/8/21 - Updated Statement on COVID Vaccine in ITP Patients from PDSA Medical Advisors

    The occurrence of severe thrombocytopenia and death of a man in Florida after receiving the Pfizer COVID vaccine is tragic and concerning. The relationship between the occurrence of severe thrombocytopenia and the vaccination, if any, is uncertain. To our knowledge, this is the first such event reported after over 5 million such vaccinations. It is impossible at this time to be certain whether or not the vaccination is causal or coincidental. Based on the available data, the benefit to risk ratio strongly favors vaccination of all adults, including those with ITP. None of the medical board members is aware of any similar events in our patient population, but we are open-minded as more information about this case or others emerge. We encourage our ITP community to notify PDSA with their own experience with the vaccine. PDSA will continue to update our patients about adverse effects relevant to the ITP community as information reaches us from the CDC, NIH, FDA MedWatch, and our collective clinical experience. To summarize, the opinion of the medical advisors of PDSA is that our patients with ITP should not be hesitant to be vaccinated based on all available information.

  • 12/28/20 - Guidelines from PDSA Medical Advisors: Should patients be vaccinated?

    The PDSA medical advisors are of the opinion that the risk-benefit ratio favors vaccination against SARS-Cov-2 for patients with ITP who meet FDA and CDC guidelines. No vaccine is “risk free”, but there is no evidence to date to suggest that the apparent very low risk of allergic reactions is any greater in patients with ITP. On the other hand, there is compelling evidence that vaccination markedly, perhaps >90-95%, reduces the risk of serious infection. We are not aware of data to indicate that the currently available vaccines are especially likely to exacerbate ITP. If there is reason for concern that the platelets may have fallen after initial vaccination, a platelet count could be obtained at the time of the booster dose 21-28 days later. More data is needed to determine if the vaccine is as effective (and if the effectiveness is as durable) in patients who received or are receiving therapy for ITP as it is for individuals in the general population. Vaccination is also indicated in patients who have had a splenectomy.


    Guidelines from the CDC’s Advisory Committee on Immunization Practices (ACIP)

    For patients with bleeding disorders:
    COVID-19 vaccine may be given to these patients, if a physician familiar with the patient’s bleeding risk determines that the vaccine can be administered intramuscularly with reasonable safety. ACIP recommends the following technique for intramuscular vaccination in patients with bleeding disorders or taking blood thinners: a fine-gauge needle (23-gauge or smaller caliber) should be used for the vaccination, followed by firm pressure on the site, without rubbing, for at least 2 minutes.

    For patients who are immunocompromised:
    Immunocompromise is not a contraindication to current COVID-19 vaccine, including those with cancer, leukemia, HIV/AIDS and other immune system problems or taking medication that affects their immune systems. However, patients should be informed that the vaccine might be less effective than in someone who is immunocompetent.

    https://www.cdc.gov/vaccines/covid-19/downloads/pre-vaccination-screening-form.pdf



COVID-19 & ITP in the News

 

  • ITP INSIGHTSSM

    critical topics in immune thrombocytopenia
    Patient education webinar series

    2021 COVID-19 Webinar Title Slide

    Watch Webinar

  • Facts over Fear: COVID-19 & ITP Virtual Town Hall Meeting with Global ITP Experts (Part 1)

    This webinar was broadcast live on April 3, 2020. Over 700 individuals registered from 44 Countries, 48 U.S. States, and 7 Canadian Provinces.

  • Facts over Fear: COVID-19 & ITP Virtual Town Hall Meeting with Global ITP Experts (Part 2)

    This webinar was broadcast live on July 30, 2020.

  • Short Video Clips - Doctors Answer Your Questions

    COVID 19 Town Hall Videos In this series of individual videos excerpted from the virtual town hall meeting, ITP doctors and experts answer specific questions about COVID-19 and ITP.

    Watch Videos

     

 

  • IMPORTANT INFORMATION RE: COVID-19 & ITP

    According to several of PDSA’s medical advisors and ITP experts, there is very little to no added risk for ITP patients being infected by COVID-19, but a patient’s ITP may worsen if they get the virus. There is no literature to support the virus would suppress platelet production any more than influenza, but some ITP patients seem to be more sensitive to systemic viral infections than others in general.

    While there is no known data on COVID-19 and patients being treated with corticosteroids or immunosuppression, the risk of immunosuppression with high dose/protracted steroids, rituximab or other immunosuppressive drugs is comparable to influenza or other systemic viral illnesses. It is recommended that ITP patients being treated with these therapies be extra diligent: frequent hand washing, avoiding overtly ill persons and seeking early medical attention if they develop symptoms compatible with this infection.

    ITP patients who have had a splenectomy are not predisposed to getting the COVID-19 virus. However, they might have trouble handling certain bacterial infections which might happen as a complication after a COVID-19 infection. That is why patients without spleens are encouraged to make sure they are up to date with their three vaccines: H influenzae (this is not the flu vaccine), Pneumococcus, and N meningitis.

    COVID-19 and ITP in Pediatric ITP: What You Need to Know

    Important information about COVID-19 and children. This information has been reviewed by PDSA medical advisors. (5/21/20)

    Read Article

  • IMPORTANT INFO FOR SPLENECTOMIZED PATIENTS

    In general, the most common cause of an overwhelming blood stream infection after one has had a splenectomy is from pneumococcus, which is a type of strep. The best ways to prevent, avoid and treat it are:

    • Get the pneumococcal vaccine every five years and check the response to it by having blood sent for antibody levels
    • Always have antibiotics available at home so if anything happens they can be started immediately
    • Plan to go to the emergency room immediately at any time there is a fever of 101 degrees or higher no matter how you feel. Do not wait to see if the fever responds to Tylenol and do not wait until the morning. If the fever happens at 3 a.m. you should be leaving home at 3:05 a.m. You will need to have a thermometer on hand and should take your temperature whenever you feel ill even if you do not feel very warm. Ideally, when you get to an emergency room, a blood culture would be done, a blood count would be drawn, your blood pressure and other things like your temperature, pulse, respiration (breathing) rate would be assessed and ideally you would get an antibiotic such as ceftriaxone right away. After that you need to be observed.

    Some physicians recommend antibiotic prophylaxis to be taken daily for life after splenectomy and that’s usually penicillin.

  • ADDITIONAL RESOURCES: COVID-19 & ITP

    • Amgen Guidance and Information for Patients including those on romiplostim (Nplate®) HERE
    • ASH COVID-19 Resources - COVID-19 and ITP: Frequently Asked Questions HERE
    • Coronavirus and IVIG HERE
    • International Resources and News HERE
    • NORD Financial Assistance Program for Rare Disease Community Members Impacted by COVID-19 MORE INFO
    • Report an Adverse Event to VAERS HERE
    • Severe Immune Thrombocytopenia Complicated by Intracerebral Haemorrhage Associated with Coronavirus Infection: A Case Report and Literature Review READ MORE
    • V-safe After Vaccination Health Checker HERE
  • GENERAL COVID-19 INFO & RESOURCES

    • CDC’s Coronavirus website HERE
    • CDC’s Resources in Languages other than English HERE
    • Coronavirus anxiety resources from Shine HERE
    • Daily updates on COVID-19 from the CDC HERE
    • Managing anxiety & stress during COVID-19 from the CDC HERE
    • NAMI: COVID-19 Guide, Information and Resources VIEW GUIDE
    • Reports show children are infected by COVID-19 less often and seem to be less affected by the virus, but it is important to remain vigilant, especially if your child is immunosuppressed. READ MORE
    • TailorMed: Financial Navigation Resources for COVID-19 HERE
    • U.S. Food & Drug Administration: Drug Shortages Database HERE
  • COVID-19 RESEARCH & DEVELOPMENT NEWS

    • Emerging scientific developments around COVID-19, including clinical trial, test kit, therapeutic progress information and more from the Immunoglobulin National Society’s R&D Progress Report on COVID-19 HERE

      Summary:
      • Coronavirus vaccine trial administers first doses to participants
      • FDA to allow COVID-19 test kits to bypass the agency’s approval process
      • New rapid COVID-19 test produces fast results
      • Multiple therapeutic investigated for the treatment of COVID-19 infection
      • Selected repurposed drugs in clinical development to treat COVID-19

    • COVID-19 Clinical Trials (US & International updated daily) HERE

 



Stay Informed

Hands connecting puzzle piecesWe will continue to monitor the situation and provide information to our patients and caregivers on COVID-19 and how it might affect ITP patients. Please continue to check the PDSA website, Facebook page and other communications from PDSA.

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