Can my COVID-19 antibodies help others? RWD is being used to find out

by Steve Davis, manager, Center for Health Solutions, Deloitte LLP

While watching a movie a few days before Christmas, I had a fleeting moment of panic. I couldn’t scratch my nose! I was completely immobilized—flat on my back with a silicone tube jutting out of each arm. This was the second time I’ve donated convalescent plasma since recovering from a mild case of COVID-19 last May. It turns out that I still had COVID-19 antibodies seven months after being infected. But how much longer will those antibodies last? Could my antibodies help others avoid severe COVID-19 symptoms? Real-world data (RWD) and real world evidence (RWE) could help answer those and other questions.

Plasma is the straw-colored part of the blood left behind once red blood cells are removed via centrifuge. It can contain virus-fighting antibodies, including those triggered by a COVID-19 infection. Once someone has recovered from COVID-19, how long will the antibodies last? A pair of studies published in the journal Science Immunology indicate that some protective antibodies stick around for at least three or four months.¹ In one study, funded by the National Institutes of Health, researchers evaluated three types of antibodies—immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM), which the body produces first when fighting an infection. While IgM and IgA antibodies faded not long after recovery, researchers found that IgG antibodies persisted in most patients beyond the duration of the four-month study.²

Plasma donations, vaccinations, and smart public-health practices can help keep people stay engaged in the fight against COVID-19.

FDA reissues EUA for convalescent plasma

On December 1, the Food and Drug Administration (FDA) reissued its August 23 Emergency Use Authorization (EUA) for convalescent plasma to treat hospitalized COVID-19 patients.³ Later that month, US Surgeon General Jerome Adams urged recovered COVID-19 patients to donate plasma. Antibodies contained in their plasma, he said, could help suppress the virus and provide patients with a clinical benefit.⁴ However, people generate different combinations of antibodies, some of which are likely more effective than others against COVID-19, according to a June report published in the Journal of Clinical Virology.⁵

The use of plasma in treating disease goes back more than 100 years. During the influenza pandemic of 1918, convalescent plasma might have been an effective treatment, according to some studies.⁶ In 1934, at a boarding school outside of Philadelphia, a school physician inoculated 64 students against the measles using plasma from a student who had recovered. Three kids developed mild symptoms, but no one else got sick.⁷ More recently, convalescent plasma was evaluated as a treatment against the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic.⁸ Plasma is already being used to treat a wide-range of illnesses, including rabies, hemophilia, and pediatric HIV. Proteins from plasma might also help fight other diseases such as Alzheimer’s and Parkinson’s.⁹

Antibodies contained in plasma, if proven to be effective against COVID-19, “could be a proof of concept” for a vaccine that introduces antibodies, Anthony Fauci, M.D., the nation’s top infectious disease expert, explained during a July 30 event at the American Red Cross’ headquarters in Washington, D.C.¹⁰ At the same event, Francis Collins, M.D., director of the National Institutes of Health, compared the human immune system to a “little biotechnology factory.” Although plasma therapy might have potential in the fight against COVID-19, RWD is needed to evaluate its effectiveness.¹¹

Pharma companies expect to rely more on RWD and RWE

Most pharmaceutical companies intend to rely more heavily on RWD and RWE, according to a recent report from the Deloitte Center for Health Solutions. In early 2020 (prior to the pandemic), we surveyed multiple leaders from 17 pharmaceutical companies about their organizations’ RWE capabilities. Nearly all respondents (94%) predicted the use of RWE in research and development will become “important” or “very important” to their organizations by 2022. More than 40% of our survey respondents said recent guidance and statements from FDA have helped encourage the use of RWD in other research and development.

How is plasma being used to treat COVID-19 patients?

RWD generated by people who receive convalescent-plasma therapy is being used by some biopharmaceutical companies to evaluate the effectiveness of the treatment. RWD is also being used to evaluate monoclonal antibodies, which are laboratory-made versions of specific proteins found in plasma.¹² At-risk people who receive these therapies early might be able to avoid serious symptoms. Here are examples of three companies that are evaluating convalescent plasma and monoclonal antibodies.  

•  Eli Lilly & Company: On December 18, the Indianapolis-based company announced it was launching a study to gather RWD on the effectiveness and safety of its monoclonal antibody therapy. The study will include a diverse population of high-risk COVID-19 patients, the company said in a prepared statement. The therapy, called bamlanivimab, was granted limited EUA in November to treat mild-to-moderate COVID-19 symptoms. Eli Lilly worked with the National Institute of Allergy and Infectious Diseases (NIAID) to generate RWD that could help determine if monoclonal antibodies can prevent or reduce the severity of symptoms in patients who have been infected.¹³ Also in December, the US Department of Health and Human Services said it had launched a seven-city pilot to administer the intravenous therapy to patients (in their homes or in long-term care facilities) who were at high risk for severe illness or complications.¹⁴
• Regeneron Pharmaceuticals:  In mid-November, EUA was granted to Regeneron's monoclonal antibody cocktail, which includes two monoclonal antibodies, casirivimab and imdevimab. The treatment is a combination of two potent virus-neutralizing antibodies (one from a recovered patient, and one from a genetically modified and immunized mouse), according to the company. During an August 5 conference call to discuss the company’s second-quarter earnings, President and Chief Scientific Officer George Yancopoulos said the antibody cocktail could offer a layer of defense for people who don’t have access to a vaccine or who might not respond well to a vaccine, such as the elderly and immunocompromised.¹⁵
• Octapharma AG: The Swiss-based company, which bills itself as “one of the largest human protein manufacturers in the world,” is assessing a plasma-based treatment in its Phase III study.¹⁶ Rather than targeting the virus itself, the company’s intravenous immunoglobin therapy (IVIG) is aimed at calming the patient’s immune response to prevent a cytokine storm where the body attacks the virus as well as its own cells and tissues. The therapy relies on antibodies harvested from plasma provided by thousands of donors, according to a company statement. The concentration of IVIG given to patients is much higher than convalescent plasma.

Could our COVID-19 experience end future pandemics?

When the novel coronavirus surfaced late last year, the Department of Defense’s (DoD’s) Defense Advanced Research Projects Agency (DARPA) was in the middle of a multi-year program to take the plasma from someone who had recovered from a novel viral infection and, within 60 days, develop antibodies that could be used to defeat it.¹⁷ I learned about this program at an industry conference last March. A former Army colonel who studies infectious disease and rapid vaccine development suggested the experience we glean from COVID-19—along with advanced technology and global cooperation—could help DARPA develop the “greatest pandemic defense the world has ever seen.” He noted that vaccine development used to take 10 to 15 years and cost hundreds of millions of dollars. The pandemic-response technology being developed could take us from discovery to clinical trials in a matter of months at a fraction of the cost, he said. Vaccines and treatments provided in the early stages of an outbreak could create firewalls to contain an outbreak, he explained.

Watch a movie, earn a cookie, maybe save a life

While effective COVID-19 vaccines are now being distributed, we might not see a significant impact until summer. Until then, therapies—including those that use antibodies—could be essential weapons against COVID-19 and the SARS-CoV-2 virus that causes it.

Ten minutes into my plasma donation, I was totally absorbed in my movie. I forgot all about my itchy nose…and the blood flowing through the silicone tubes that crisscrossed my chest. It’s still unknown how effective convalescent plasma is in reducing the severity of symptoms in COVID-19 patients. RWD and RWE are being used to develop deeper insight. In the meantime, people who have recovered from the disease might want to consider a plasma donation. The process is relatively quick (about 90 minutes), fairly pain-free (a quick needle poke in each arm), and an excellent excuse to let emails and phone calls go unanswered for a couple hours. Plus, you walk away with a cookie, a juice box, and a sense of helping.

Endnotes

^{1.        Defining the features and duration of antibody responses to SARS-CoV-2 infection associated with disease severity and outcome, Science Immunology, December 7, 2020}

^{2.        Ibid.}

^{3.        Coronavirus (COVID-19) update, FDA News Release, December 1, 2020}

^{4.        U.S. Surgeon General Calls for COVID-19 Survivors to Donate Plasma, US Department of Health and Human Services, Press Release, December 21, 2020; Wanted: Plasma from recovered COVID patients, Kaiser Health News, December 22, 2020}

^{5.        Challenges of Convalescent Plasma Therapy on COVID-19, Journal of Clinical Virology, June 2020}

^{6.        Convalescent plasma: new evidence for an old therapeutic tool, Blood Transfusion, June 11, 2015}

^{7.        How a boy’s blood stopped an outbreak, The Wall Street Journal, February 27, 2020}

^{8.        Treatment for emerging viruses: Convalescent plasma and COVID-19, Transfusion and Apheresis Science, June 2020}

^{9.        Plasma giant Grifols to buy Silicon Valley startup targeting blood proteins for age-related diseases, STAT, September 7, 2020}

^{10.     Remarks by President Trump in a Roundtable on Donating Plasma, White House transcript, July 30, 2020}

^{11.     Ibid.}

^{12.     Antibody cocktail to prevent and treat COVID-19 enters late-stage trials, Live Science, July 8, 2020}

^{13.     Lilly to begin pragmatic study of neutralizing antibody bamlanivimab (LY-CoV555) for COVID-19 in New Mexico, Eli Lilly Press Release, December 18}

^{14.     CVS Health selected by HHS, as part of a pilot, to administer recently authorized COVID-19 therapy to eligible patients in long-term care facilities, CVSHealth press release, December 2, 2020}

^{15.     Transcript of Regeneron 2Q earnings conference call, August 5, 2020}

^{16.     Octapharma uses IVIG as potential treatment for COVID-19, BioSpace, August 7, 2020}

^{17.     How a secretive Pentagon agency seeded the ground for a rapid coronavirus cure, Washington Post, July 30, 2020}

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