Across the globe there have been around 8.5 million cases reported of acute respiratory syndrome; which is thereby related to COVID -19. There has been a large number of increase in the amount of clinical trials for patients with COVID-19. Although around 46% of those trials either excluded pregnant women or did not address pregnancy specifically.
Although as per human data, there was as such no excessive risks or adverse pregnancy outcomes reported in those pregnant women who were exposed to remdesivir in an RCT testing. This RCT testing was investigational therapies for Ebola virus disease.
As per reports these trials might be conducted in parallel to phase 3 trials within the general population, avoiding the exposure of pregnant women to drugs that have failed in phase 1 and a couple of trials. As the standard of look after hospitalized patients with COVID-19 in many centers across the planet includes participation during a clinical test, we not only have the chance but also an obligation to supply participation to pregnant women.
The Coalition to Advance Maternal Therapeutics, had issued a public letter which was sent to the National Institutes of Health along with the Food and Drug Administration, stating and requesting the inclusion of pregnant women in relevant COVID-19 trials.They urged advocating for ladies through research. Thus, including pregnant women in clinical trials of interventions for COVID-19 and adapting ongoing clinical trials to accommodate their inclusion should be considered an ethical imperative. This is to be done, so as to bring a better representation of the population in clinical research.
Ref: https://www.acpjournals.org/doi/10.7326/M20-3106
