Pregnant women with coronavirus can now participate in a trial using plasma from survivors of the infection to treat them, a rare occurrence in drug testing.
Clinical trials that aren’t specific to assessing drugs or treatments intended for pregnant women have overwhelmingly excluded this group, citing concerns over endangering a woman and her unborn child.
In fact, only two percent of some 900 COVID-19 trials have studied how the disease and its treatments affect pregnancy. Most others simply leave pregnant women out, according to the University of Pennsylvania, which is running the plasma trial.
But pregnant women – and their developing babies – are no less vulnerable to coronavirus than are their peers, and not including them in trials means prolonging uncertainty about how they can be treated for the life-threatening infection.
Scientists are still studying just how effectively plasma from recovered coronavirus patients is at treating those who still have the virus, but at least now a safe potential treatment will be available to the pregnant women in the trial, and doctors will better know how it affects them.
University of Pennsylvania is allowing pregnant women with coronavirus to enroll in its trials of plasma from COVID-19 survivors to treat the infection (file)
Thousands of American coronavirus survivors have donated their blood plasma in the hopes that it may contain antibodies to the virus that will help others fight off the infection.
Plasma transfusions, generally speaking, are considered safe.
The treatment protocol has been used for hundreds of years, during emergencies ranging from battlefield infection prevention to treating the 1918 influenza pandemic.
And a recent Mayo Clinic study found that just one percent of patients treated with convalescent plasma had serious side effects.
With a good safety profile, plasma makes a good candidate for coronavirus treatment testing in pregnant women.
For U Penn, it will be the Perelman School of Medicine’s first clinical trial not related to pregnancy itself to include women who are expecting.
Researchers there believe it’s the first COVID-19 trial not related to pregnancy to enroll pregnant women.
In all medical research, ‘we have a natural misplaced default action to exclude pregnant women from trials,’ Emma Meagher, vice dean for clinical research at the Perelman School of Medicine, told WHYY radio.
‘And part of that historically is you have to consider two lives, and the impact on the child is virtually impossible to assess in utero.’
It’s far too soon to know how coronavirus infection during pregnancy will affect a woman’s newborn over the course of their life.
In the meantime, doctors are approaching the matter with extreme caution – even to a fault, some have suggested.
One woman in Montreal gave birth to a premature baby amid the coronavirus pandemic.
The yellowish, liquid component of blood, plasma (pictured) contains immune cells, including antibodies that may fight coronavirus infection. A recent Mayo Clinic study found the treatment safe, and U Penn researchers will now administer it to pregnant COVID-19 patients
Because she tested positive for COVID-19 at the time of her baby’s birth, physicians at Sainte-Justine Hospital felt it was unsafe for her to touch her infant.
But she continued to test positive for 55 days thereafter, even after her symptoms had subsided, Stat News reported.
So long as she was covid-positive, the staff at Sainte-Justine continued to keep her separate from her baby – perhaps unncessarily, as some virologists believe she was unlikely to have still been shedding infectious viral particles at that point, but the test was unable to distinguish between active and inactive virus.
Treatment with convalescent plasma might help pregnant women recover more quickly from coronavirus and avoid such long separation periods from infants.
U Penn is conducting two plasma trials: one is recruiting only patients on mechanical ventilators, and the second is recruiting those severely ill with coronavirus and hospitalized, but not necessarily on ventilators.
The latter is recruiting 80 patients, who will be randomly assigned to receive or not receive plasma. Pregnant women may be among them.
Pregnant women were excluded for the National Institutes of Health’s (NIH) multi-arm trial of potential coronavirus treatments, as well as from the NIH trial that led to emergency use authorization for the antiviral remdesivir.
Not only does that mean doctors have little information on the safety of such treatments for pregnant women, it means pregnant women aren’t getting the potential treatments.
So far, rates of severe illness or death don’t seem to be higher any higher among pregnant women than among other people – in fact, women appear to get less sick, less often, compared to men.
But two months ago, we also thought that children might be relatively unaffected by coronavirus. Now, doctors are scrambling to find treatments for a new, life-threatening pediatric inflammation condition that is believed to be triggered by coronavirus.
‘What COVID really brought to the forefront was a need for us to challenge this accepted principle and dogma that pregnant women cannot be enrolled’ in trials, Dr Meagher told WHYY.
‘And it was so stark, because at the time these studies were designed, there was no accepted therapy.’