COVID-19 researchers have been outspoken about the need to have drug trials that include pregnant and lactating women. Even though these women were not included in early trials on the drug remdesivir, many doctors prescribed the drug for their pregnant COVID-19 patients anyway, under compassionate-use guidelines, to save their lives. This highlights the need to include pregnant women in drug and treatment trials to evaluate their safety and efficacy in that population.

The obvious reason researchers shy away from using pregnant women in clinical trials for any sort of drug is that we don’t know what effect it can have on the developing fetus. According to The Wall Street Journal, thalidomide and diethylstilbestrol, known as DES, were once prescribed to pregnant women until it was found they caused serious health problems for the unborn child.

The Coalition to Advance Maternal Therapeutics wrote to the heads of the National Institutes of Health and the Food and Drug Administration in March urging them to find ways to include pregnant women and lactating women in their COVID-19 vaccine and therapeutics development, said the Journal.

Fortunately, the University of Pennsylvania said they are allowing both pregnant and lactating women to enroll in their two convalescent plasma trials for COVID-19 patients. This will give physicians more information on how to safely treat this group of patients.

“If we don’t enroll them in trials, we won’t have therapies for them when they are sick,” said Katharine Bar, assistant professor of infectious diseases and principle investigator in the two university trials. Convalescent plasma treatments weren’t developed by pharmaceutical companies which can be reluctant to test on pregnant women and have been used in other applications to treat pregnant patients, said the Journal. Another clinical trial of convalescent plasma is under way in New York City that also allows pregnant women to enroll.

According to the Mayo Clinic, convalescent plasma therapy has been successfully used for years to treat infectious diseases. The plasma comes from patients who have recovered from diseases, such as COVID-19, and provides protective antibodies that may help people with COVID-19 to fight the disease.

According to the Journal, convalescent plasma appears to be generally safe even for COVID-19 patients who have severe and even life-threatening disease.