About this Research Topic
Since the beginning of 2021, there have been different therapies authorized against SARS-CoV-2 for early mild-to-moderate COVID-19 and for use in hospitalized patients. Monoclonal antibodies, single or in combination, and antiviral agents have been widely used worldwide and across the variant era.
The efficacy of these drugs as early treatment for mild-to-moderate COVID-19 has been demonstrated in phase 3 trials in terms of reduction of risk of hospitalization/death in high-risk patients. Nevertheless, in vitro, data questioned the efficacy of monoclonal antibodies against the Omicron sublineages based on the reduced neutralization activity. Moreover, the Omicron era has been characterized by a high rate of vaccinated people and a lower probability of hospitalization, which are very different from the phase 3 trials mentioned above: in this scenario, it would be very difficult to assess the impact of the treatment on the “classical” endpoint of clinical failure, and it will be reasonable to investigate other outcome and aspects related with early therapies.
In addition, both antiviral and monoclonal antibodies have been used in severe COVID-19 in hospitalized patients with specific characteristics. Currently, new strategies of antiviral and mAbs, alone or in combination, with extended and unconventional durations of therapies, have been proposed for hospitalized patients with prolonged SARS-CoV-2 infection, but these need more robust data to support the evidence of their efficacy.
This collection aims to approach the clinical, virological, immunological, and epidemiological aspects of administering treatment against COVID-19.
Without available data from randomized clinical trials, investigations about the impact of the different authorized treatments could address a more tailored and timed treatment approach. Exploring new outcomes of treatment evaluation and finding new surrogate markers of efficacy could also be useful for the future design of new drug studies.
Finally, the relationship between in vitro and in vivo efficacy of drugs needs to be explored to clarify better the mechanisms of actions of the drugs used, as well as the immunological mechanisms underlying the eradication of SARS-CoV-2 in certain kinds of patients need to be explored.
We encourage the submission of randomized trials as well as observational human cohort studies, retrospective and/or prospective, and case series or case reports that delve into specific, unresolved aspects. Review articles will also be considered.
We expect submissions based on (but not limited to):
• Human cohorts treated for COVID-19, which could provide real world evidence on the efficacy of treatments
• Treatment of special populations (e.g., Aged, unvaccinated, hematological, transplant recipient, immunosuppressed)
• Unconventional treatment schedules (as combination therapies)
• Predictors of clinical and virological failure
• Viral dynamic and evolution after treatment
• The emergence of mutations and resistance to drugs
• Impact of treatments on the immune response to infection
• Impact of treatment on transmissibility
• Management of drug-drug interaction
• Management of adverse effect
The efficacy of these drugs as early treatment for mild-to-moderate COVID-19 has been demonstrated in phase 3 trials in terms of reduction of risk of hospitalization/death in high-risk patients. Nevertheless, in vitro, data questioned the efficacy of monoclonal antibodies against the Omicron sublineages based on the reduced neutralization activity. Moreover, the Omicron era has been characterized by a high rate of vaccinated people and a lower probability of hospitalization, which are very different from the phase 3 trials mentioned above: in this scenario, it would be very difficult to assess the impact of the treatment on the “classical” endpoint of clinical failure, and it will be reasonable to investigate other outcome and aspects related with early therapies.
In addition, both antiviral and monoclonal antibodies have been used in severe COVID-19 in hospitalized patients with specific characteristics. Currently, new strategies of antiviral and mAbs, alone or in combination, with extended and unconventional durations of therapies, have been proposed for hospitalized patients with prolonged SARS-CoV-2 infection, but these need more robust data to support the evidence of their efficacy.
This collection aims to approach the clinical, virological, immunological, and epidemiological aspects of administering treatment against COVID-19.
Without available data from randomized clinical trials, investigations about the impact of the different authorized treatments could address a more tailored and timed treatment approach. Exploring new outcomes of treatment evaluation and finding new surrogate markers of efficacy could also be useful for the future design of new drug studies.
Finally, the relationship between in vitro and in vivo efficacy of drugs needs to be explored to clarify better the mechanisms of actions of the drugs used, as well as the immunological mechanisms underlying the eradication of SARS-CoV-2 in certain kinds of patients need to be explored.
We encourage the submission of randomized trials as well as observational human cohort studies, retrospective and/or prospective, and case series or case reports that delve into specific, unresolved aspects. Review articles will also be considered.
We expect submissions based on (but not limited to):
• Human cohorts treated for COVID-19, which could provide real world evidence on the efficacy of treatments
• Treatment of special populations (e.g., Aged, unvaccinated, hematological, transplant recipient, immunosuppressed)
• Unconventional treatment schedules (as combination therapies)
• Predictors of clinical and virological failure
• Viral dynamic and evolution after treatment
• The emergence of mutations and resistance to drugs
• Impact of treatments on the immune response to infection
• Impact of treatment on transmissibility
• Management of drug-drug interaction
• Management of adverse effect
Keywords: COVID-19, SARS-CoV-2, Antiviral, monoclonal antibodies, therapy, resistance, sublineages, immune response, neutralization, transmission
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