Dr. Nicole Saphier: Plasma therapy a promising step in fight against coronavirus

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FDA issues emergency authorization for plasma to treat COVID-19 patients

FDA authorizes use of convalescent plasma to treat coronavirus; Fox News contributor Dr. Nicole Saphier

For the last six months, the world has been fighting a novel pathogen with minimal treatment options and without a vaccine.

On Sunday, President Trump announced the Food and Drug Administration is issuing an emergency use authorization for (EUA) convalescent plasma in hospitalized patients, another step forward in the fight against COVID-19.

Plasma is the portion of blood that contains the important antibodies which block the spike protein of SARS-CoV-2 and ultimately prevent cellular replication and invasion of the virus into human tissues. The plasma is retrieved from people who have already recovered from COVID-19 and have circulating IgG antibodies in their bloodstream.

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The use of convalescent plasma is not novel to scientific discovery. In fact, it’s been used for nearly a century treating various conditions. It has proven safe in a large reputable observational study performed by the Mayo Clinic in the treatment of COVID-19. The people in the study who benefited the most from the treatment were those over 80 years old not on a ventilator, the most vulnerable.

While large observational studies like the Mayo Clinic one are important in the pursuit of medical advancement, the gold standard for determining the true causal relationship between a treatment and its potential benefit is a prospective, randomized controlled one.

While the EUA is based on observational data suggesting high doses of IgG in some people may have benefits, it will be crucial to further assess the efficacy of convalescent plasma and any potential treatments with randomized controlled studies to eliminate potential bias and confounding factors.

It may not be the magic ticket to end the pandemic, but can it save lives if sufficient quantities of IgG are given early enough? Data from over 30,000 people in the study suggest so. And because of that, every American should be rejoicing.

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While there may be some people attempting to dampen the enthusiasm of the announcement, any treatment that is proving safe and potentially efficacious after being administered in over 70,000 Americans deserves praise. Convalescent plasma is currently being used across the country under an expanded access program but the EUA gives further access by cutting through potential administrative delays.

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Since convalescent plasma treatment involves giving donated plasma with antibodies from patients who have recovered from COVID-19, it is imperative that people who have recovered from the illness donate to help others. Otherwise, there is a high likelihood that we will have a shortage of the treatment and many people will no be able to benefit from it.

In a similar vein, as we move forward exploring antibody therapy, monoclonal (lab manufactured) antibodies (mAbs) are declaring their role in treating COVID-19. Specifically, Leronlimab, created by a lesser-known biotech company CytoDyn, is currently enrolling two placebo-controlled double-blind clinical trials that have already entered Phase 3. Phase 2 results reported in July passed all safety checks.

Originally manufactured as an investigational injectable for HIV, Leronlimab is also demonstrating an ability to prevent and/or lessen the cytokine storm that causes much of the severity in COVID-19 symptoms. Albeit a small sample size, early Phase 1 results showed patients on Leronlimab experienced 63% less seriously adverse events than the control group, while also demonstrating reduction in viral load to zero after 14 days.

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While all of this is promising, Phase 2 efficacy data has not been released yet. If that data demonstrate similar results to Phase 1, an EUA may be in the near future for this medication while Phase 3 enrollment is ongoing.

As children head back to school and outbreaks are still occurring, it is hopeful that we are making progress on the treatment front and the FDA is doing what it can to expedients safe treatments. For the over 1 million Americans who have already recovered from COVID-19, please consider donating your plasma today so that this potentially life-saving treatment can be readily available nationwide.

CLICK HERE TO READ MORE FROM NICOLE SAPHIER, M.D.