7. Conclusion
The spread of the new COVID-19 was inevitably followed by the research
for therapies able to counteract severe signs and symptoms of this
disease. Today, pharmacological researches are focusing on different
drug classes, including antivirals, immunomodulatory and
anti-inflammatory agents, anticoagulants and antiplatelet drugs,
convalescent plasma, and vitamins. Other drugs are currently
administered among inpatients and outpatients with Covid-19, such as
antibiotics. The use of these drugs is, on many occasions, necessary,
given that patients with COVID-19 may also develop bacterial infections,
such as pneumonia. In this regard, it should be underline how much
important is that the use of any antibiotic is under clinicians’ strict
control, due to the widespread and inappropriate use of these drugs even
during the COVID-19 pandemic. Indeed, data recently shared by the WHO
revealed that, while up to 15% of severe COVID-19 patients develop
bacterial co-infection, almost 75% of patients actually receive them
(World Health Organization, 2020d).
Given the absence of a specific drug able to block the replication of
SARS-Cov-2, drugs repurposing has represented the main approach recently
used. Indeed, many drugs that are currently used to neutralize COVID-19
signs and symptoms were already approved but for other therapeutic
indications. This is the case, for example, of antivirals, whose role
however is still debated. Also for remdesivir, which is the only drug
recommended for COVID-19, some concerns related to its efficacy profile
were raised by the WHO based on the results of open-label SOLIDARITY
trial. Given these concerns, the EMA is currently re-evaluating the
drug.
Many immunomodulatory and anti-inflammatory drugs have been tested in
patients with COVID-19 as well. Based on current evidence and
considering the limitations of published clinical studies on these
drugs, no firm conclusion can be drawn. Among these drug classes,
tocilizumab, hydroxychloroquine and corticosteroids have been
extensively studied, even though only the use of corticosteroids seems
to be supported by robust evidence, both for outpatients and inpatients
requiring supplemental oxygen. In addition, it should be underline the
significant role of NSAIDs, mainly ibuprofen and paracetamol, especially
in patients suffering from a mild form of COVID-19 (early stage –
manageable at home) to solve symptoms like fever and joint and muscle
pain.
The role of heparins is noteworthy too. Indeed, the administration of
these drugs in critically ill patients is crucial in order to reduce the
thromboembolic risk, which is one of the most serious consequences of
COVID-19.
In addition, based on the results of published studies, it is still not
clear the role of convalescent plasma and vitamins. Therefore, we should
wait for results from clinical trials, which are currently ongoing to
evaluate the effects of these therapies on mortality, morbidity,
prevention and treatment of COVID-19.
Other drugs, such as the combination of monoclonal antibodies REGN-COV2,
might represent a powerful strategy to avoid patients’ hospitalization
and alleviate the burden on the health care system. At this moment,
REGN-COV2 and bamlanivimab - which will be used for the treatment of
mild to moderate COVID-19 in adult and pediatric patients – received
the approval from the FDA, but not yet across European countries (Food
and Drug Administration).
Lastly, out of 13 vaccines currently under phase 3 clinical development,
four are under evaluation by the EMA. Among them, two are in the first
rolling review evaluation, while the remaining are in the second phase
of rolling review. The preliminary efficacy data published in the
literature (for one vaccine) and through pharmaceutical industries’
press releases (three vaccines) revealed a high efficacy rate and a good
safety profile. However, according to the EMA, after the approval of
these vaccines, further post-marketing studies that evaluate vaccine
effectiveness are needed in order to better understand immediate and
longer-term protection in a larger range of subjects. In conclusion, the
analysis of real world data is strongly needed to confirm the favourable
efficacy and safety profile of drugs currently used for the treatment of
COVID-19 as well as of vaccines for its prevention.
Competing Interests’ Statement: none.