Calling All Heroes: The Power of a Plasma PartnershipOctober 2020
Topics: Public Health, Disease Outbreaks, Epidemiology, Collaborations, Immunology, Clinical Medicine, Pharmacology, Biotechnology
When a tidal wave of COVID-19 began heading for the United States, clinicians, epidemiologists, and researchers began looking for ways to save lives. They realized the critical need to bring experts together to act—in a situation with no clear path.
New virus. No cure. No vaccine. And no time to lose.
Many of these experts began coalescing around the idea of convalescent plasma—blood plasma from patients who have recovered from an illness. It’s been used for more than 100 years to treat or prevent such illnesses as hepatitis A, measles, mumps, diphtheria, Ebola, and the Spanish Flu of 1918.
“Taking rapid, effective action was a goal for the COVID-19 Healthcare Coalition, which MITRE and Dr. John Halamka of Mayo Clinic formed in mid-March,” says MITRE’s Dr. Brian Anderson. “Soon after, we began hearing from groups around the country who wanted to explore the use of plasma, both for immediate transfusion of severely ill patients and for development of hyperimmune globulin products and vaccines. The treatment was available to severely ill patients through the compassionate-use regulation.
“Independent efforts began popping up around the country, and Halamka, other C19HCC members, and I saw the need to bring together as many of these efforts as possible.
“For example, we talked to a group of researchers who came from leading institutions such as Michigan State, Johns Hopkins, and Mayo Clinic, which had quickly stood up a website to document the results of plasma transfusions, a treatment focused on immediate results. We also talked to a coalition of pharma companies who needed to collect plasma for more long-term treatments, including HIG, monoclonal antibodies, and vaccines.”
Adds Halamka, “We knew the need for plasma would increase quickly and we wanted to limit duplication and confusion. We talked to all these stakeholders about a combined effort that would provide clear communications to donors, ensure the safe, streamlined collection of plasma for diverse needs, and manage data collection and analysis.
“In all these projects, MITRE’s role is to make sure that the path forward for the use of plasma is determined by data-driven scientific evidence to rigorously answer the important questions regarding safety and efficacy,” says Dr. Jay Schnitzer, MITRE’s chief medical and technology officer.
Before they could even answer those questions, the researchers needed to get people to donate to the cause.
Rapid Response from a Coalition of Coalitions
Two important programs resulted from discussions among health systems, big tech companies, nonprofit organizations (including blood banks), foundations, pharma companies, and others. This “coalition of coalitions” hammered out a plan that would create a central pipeline of plasma donations and ensure fair and equitable distribution of the plasma—a process that would make it easy for donors and hospital systems to participate.
The government supported rapid response and a centralized effort, and the Food and Drug Administration (FDA) designated Mayo Clinic to lead the national Expanded Access Program for convalescent plasma in early April, with Dr. Michael Joyner, principal investigator. Mayo Clinic created a national online physician/patient registry to increase access to investigational convalescent plasma and evaluate the safety of this experimental therapy.
As part of this program, hospital systems around the country began sending data to Mayo on the results of treating patients with plasma. The team has analyzed data over the past few months and published preliminary findings on the safety and potential benefits of plasma.
The pre-print of the study reports that, “These data provide robust evidence that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19, and support the notion that earlier administration of plasma within the clinical course of COVID-19 is more likely to reduce mortality.”
This work, and studies by others in the U.S. and around the world, was used in the FDA’s decision to issue an Emergency Use Authorization for plasma, which allowed doctors to provide the treatment to a wider range of patients.
“It means we will need more donors to provide plasma, both to save lives and to continue research, including supporting numerous ongoing clinical trials looking at the safety and effectiveness of plasma treatments,” Halamka said.
“The Fight Is In Us” (TFIIU) campaign drives that message to those who can help.
The Heroes Among Us
Fighting the pandemic has brought out heroes in communities everywhere—from frontline workers to people who have recovered from COVID-19 and donated their plasma to save lives.
In the spring, however, most survivors had never heard of convalescent plasma and didn’t know they could potentially help treat other patients. In response, members of the C19HCC and other coalitions combined efforts to launch a communications campaign. They wanted to quickly spread the word and educate the nation about the need for plasma donations.
The Fight Is In Us campaign has encouraged tens of thousands of survivors to donate plasma. A range of celebrities has made public-service announcements to spur the public to the site.
In the first three weeks, TFIIU’s site received 48,000 hits from across 40 states. To date, more than 2.2 million have visited the site, and more than 39,000 people have clicked through to schedule donations.
This campaign has attracted world-leading medical and research organizations, blood centers, life science companies, tech companies, foundations, media and advertising companies, and survivor groups. Everyone involved has donated their time and resources. For example, Microsoft built the website and the tools that guide people through the process: Are you eligible to donate? What’s involved? Where’s my nearest donation location?
“The TFIIU coalition asked MITRE to serve as the steward for the operations of this platform and ensure the data is kept secure,” Anderson adds. “We often serve as the trusted party among groups that include a diverse range of organizations.”
The Fight Is In Us program makes it as easy as possible for people to donate. For example, if a donor doesn’t have a ride to the nearest donation center, Uber Health will provide a free round trip. Other TFIIU members are spreading the word through their networks.
LabCorp, which processes thousands of COVID-19 antibody tests every day, provides information about The Fight Is In Us to anyone who tests positive. Actions like this continue to drive donors to the site.
Fighting Until the Enemy Is Vanquished
“The Fight Is In Us coalition will continue to encourage donations as long as needed,” Anderson says. “We’ve just added a Spanish-language version of the site, and we’ve brought in new spokespeople, such as basketball star Marcus Smart.”
In addition, the public outreach has been greatly increased by a government Operation Warp Speed (OWS) activity.
“The goal of this work is to support local campaigns to drive people to the TFIIU website,” said James O’Neal, lead of the MITRE team that is working with OWS. “We’re focusing on 14 cities that have been hit hard by COVID-19—such as Houston and Los Angeles—as they contain both potential donors and receivers.
“This campaign is educating people about the potential benefits of plasma by sharing the scientific evidence available to date. And we’re recognizing the many heroes in these communities who have already donated,” he adds.
“People and organizations from around the country have come together to fight the virus—and we’ll keep on until we beat it.”
Learn more about The Fight Is In Us and see if you're a candidate for donation.
—by Beverly Wood
Explore More at MITRE Focal Point: Pandemic Response