The novel coronavirus (SARS-CoV-2) presents a stiff challenge for health professionals where information and research on therapeutic options for the virus and disease needs to keep abreast with clinical management of patients. There are many re-purposed and new therapies being trialed for the prevention and treatment of its clinical disease, COVID-19. A search of a trial registry (Clinicaltrials.gov) in April 2020 revealed more than 500 trials already registered for “SARS-CoV-2” or “COVID-19”. A manual search of the inclusion and exclusion criteria of 250 registered interventional drug or vaccine trials revealed that more than 80% trials exclude children or pregnant women. On one hand, pregnant women are at a similar risk of contracting the virus as the general population, and their risk of adverse outcomes from COVID-19 is not thought to be high.1 On the other hand, how the virus, the disease or treatment may affect the fetus and the neonate is not yet entirely understood. Similarly, there are only a limited numbers of trials, which include children. Children of all ages are planned to be included in the RECOVERY trial, a national trial of COVID-19 conducted from Oxford University in the United Kingdom (https://www.recoverytrial.net/). Some other trials include children over 12 years or 15 years of age, but the inclusion of children is more an exception to the rule instead of the norm for COVID-19 intervention trials. Although severe COVID-19 in children seems rare, adverse outcomes in children, such as respiratory or multiorgan failure, acute respiratory distress syndrome (ARDS), and even death have been reported.2 We wonder whether it is justified that so many ongoing or planned trials exclude children and pregnant women. Can we afford to wait for intervention trials to be completed on the adult, non-pregnant population to make a judgement on the use of COVID-19 candidate drugs in children and pregnant women with suspected or proven COVID-19 or should we involve them in trials now?

Pregnant women have historically been excluded from clinical trials of new drugs or therapies for the general adult population.3 In some ongoing and planned trials for COVID-19, a prerequisite for inclusion of female adult participants is for them to practice birth control or use a medically accepted contraceptive method. When such a requisite has been put forward in the past, those trials ran the risk of inadvertent pregnancies and exposure to trial drugs in an uncontrolled manner.4 The exclusion of pregnant participants was traditionally justified due to the unforeseen teratogenic risks to the fetus and adverse pregnancy outcomes of new medications. However, it has been argued that excluding pregnant women from research participation can only be justified if the trial has no prospect of medical benefit to the pregnant woman, and the studied intervention has a known or plausibly inferred risk of significant harm to the fetus.2 Although longstanding consensus suggests that the inclusion of pregnant women in research should be promoted, the recruitment and retention of pregnant women in interventional trials of adult population continues to remain a challenge.5

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