OPERATION: Warp Speed

Overall Objective

• The objective of messaging/announcements is to communicate
• Information about CCP and the rationale behind need for patients who have recovered from COVID-19 to donate Convalescent Plasma (CCP) as a POTENTIAL treatment for COVID-19
• Who could be eligible donors, explain the need, and address common questions/concerns
• How to donate – available resources for information, locating nearest plasma collection centers
• Strategy and actions of USG in driving awareness and facilitating CCP collections
• Where available resources and information can be found (through FDA)

Clinical Context: The clinical evidence on efficacy of CCP as a potential treatment for patients infected with COVID-19 is STILL UNDER INVESTIGATION. Currently there are limited treatment options that directly combat the virus. Convalescent plasma offers one potential way to help patients fight the disease. As there are no FDA approved treatments for this disease, CCP is being clinically evaluated to determine its efficacy for treatment of COVID-19.

COVID-19 Convalescent Plasma

1. What is COVID-19 Convalescent Plasma?
   Plasma is a fluid & protein component of blood. When it is collected from patients who have recovered from the novel coronavirus disease, it is known as “COVID-19 Convalescent Plasma” or “CCP”. COVID-19 patients develop antibodies – proteins developed by the immune system to help fight infections, which then circulate in the blood plasma for a period after the patient has recovered from the virus. This plasma (the fluid containing antibodies, other proteins) can be collected from a recovered patient and transfused into the blood of a sick patient to help them combat the virus.
2. Why is CCP important to fight COVID-19?
   Currently there are limited treatment options that directly combat the virus. Convalescent plasma offers one potential way to help patients fight the disease. As there are no FDA approved treatments for this disease, CCP is being clinically evaluated to determine its efficacy for treatment of COVID-19.
3. How effective is CCP to fight COVID-19?
   Studies investigating the efficacy of CCP are ongoing. Early results from the FDA’s Expanded Access Program show that CCP is safe for use in patients, but more data is being collected and analyzed to determine its efficacy.

Donor Eligibility & Questions/Concerns

1. Who can donate?
   People who have fully recovered from COVID-19 for at least 14 days are encouraged to consider donating plasma. Individuals must have had a prior diagnosis of COVID-19 documented by a clinical test and meet other donor criteria for blood or plasma donation, as specified by the collection facility.
2. Can people who are asymptomatic to coronavirus disease donate?
   CCP sourced from people who are asymptomatic to coronavirus disease could be helpful in fighting COVID-19 as well. Therefore, asymptomatic individuals are encouraged to consider donating plasma. Individuals must have had a prior diagnosis of COVID-19 documented by a laboratory test and meet other donor criteria for blood or plasma donation, as specified by the collection facility.
3. Can people who are unsure if they are infected by COVID-19 donate?
   Individuals who are unsure if they are infected are recommended to get tested for COVID-19. To donate CCP, individuals must have had a prior diagnosis of COVID-19 and meet other donor criteria for blood or plasma donation, as specified by the collection facility.
4. Can individuals who were not infected with COVID-19 still donate blood?
   People who have not been infected with COVID-19 are encouraged to continue donating blood or plasma for other medical purposes to help blood centers across the country cope with rising demand for blood supply.
5. Will I lose my immunity to COVID-19 if I donate my plasma?
   Donating plasma does not significantly weaken your body’s immune system or its ability to fight off the virus that causes COVID-19.
6. How safe is plasma donation?
   Thousands of people safely donate plasma every day. The collection process uses sterile tubing and supplies for each donation. The tubing and supplies are discarded after each collection and are never reused. Blood does not come in contact with the collection machine. Donors can visit the blood centers and source plasma collector websites for more information about safety precautions available at collection facilities
7. What precautions are donor centers taking to ensure the safety of donors from re-infection?
   In addition to regular precautions and safety mechanisms, several extra precautions are taken to prevent re-infection of COVID-19. These are a few of the extra precautions that donor centers take:
   1. Pre-entry screening for COVID-19
   2. Following social distancing guidelines
   3. Enhanced personal protective equipment used by staff
   4. Enhanced cleaning and disinfecting procedures

Donation Process

1. Where can plasma be donated?
   There are hundreds of FDA licensed donor centers and hospitals across the United States where plasma can be donated. Donors can donate at blood centers – American Red Cross or America’s Blood Centers, such as OneBlood. Donors can also give at source plasma collectors. Donors can find their nearest donor centers by visiting one of the links on the FDA website or thefightisinus.org.
2. How many times can a donor donate?
   Individuals who have fully recovered from COVID-19 and are willing to donate their blood plasma are encouraged to donate as many times as allowed by the donor center. Donor centers may have additional guidelines. Generally, an individual can donate their plasma multiple times, based on guidelines from donors and the collection center. We encourage donors to donate as many times as possible to maximize CCP availability. Consulting a doctor is recommended to address any concerns or to seek additional guidance.
3. How long does it take?
   Depending on the collection facility, a CCP donation takes between 90 minutes and 3 hours . Return visits for additional donations can often be quicker as the donor’s information is already in the system.

FAQs: USG Strategy Efforts to Encourage Donation & Collection

1. How is the US Government raising awareness?
   Efforts were initiated across three main streams:
   1. A broad-based national awareness effort is being pursued, through FDA website and The Fight Is In Us campaign to promote awareness on CCP donation, provide donor resources and directions to the collection centers for donation
   2. Multiple USG agencies and external stakeholders like state / local / community officials, leaders and celebrities are being engaged to explore mechanisms to engage patients / donors at a local / community level.
   3. Furthermore, external organizations are also being engaged to help with direct donor outreach – to known confirmed recovered patients (e.g., associations of providers/physicians, commercial payers, public health and contact tracing agencies, etc.).
2. Is there enough collection capacity to handle donations?
   The USG is coordinating with major blood / plasma collection centers, hospitals and source plasma collectors across public and private sectors to monitor and assess collection capacity needs. Active steps are being taken to expand collection capabilities in prioritized hotspot areas to cover white spaces and make collection centers accessible to areas with high density of donor population.
3. How is USG expanding collection capabilities?
   In hotspot areas with high incidence of infections and high density of potential donor population, collection capacity is being expanded along two fronts:
   1. Current capacity is being maximized by expanding existing collection facilities for blood / plasma collection, academic medical centers and hospitals
   2. New capacity is being created through temporary collection centers and fleet of mobile collection units – to extend accessibility to potential donors
4. What areas should be prioritized to encourage donation?
   Areas with high population of eligible donors – those who have recovered from COVID-19 and meet regular plasma donation criteria, are being prioritized. As the rates of incidence of infections (over past ~8 weeks) keep evolving across the country, the priority areas are updated. Initial focus includes 15 hotspot areas with a high density of potential donors. Within these priority areas, local awareness campaigns and direct donor outreach are planned to maximize CCP awareness and donations.

FAQs: Additional Resources & Information

1. Where can donors find more information?
   The FDA website are good resources for information on donating plasma. These pages will help you find information and places near you to donate, including AABB, America’s Blood Centers, American Red Cross, Blood Centers of America, CoVIg-19 Plasma Alliance, OneBlood, National COVID-19 Convalescent Plasma Project, and reference to Plasma Protein Therapeutics Association.