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.