Clinical Scorecard: A Swift Systematic Review of COVID-19 Treatments Authorized by the U.S. Food and Drug Administration
At a Glance
Category
Detail
Condition
COVID-19 infection
Key Mechanisms
Use of antivirals, monoclonal antibodies, and convalescent plasma to treat COVID-19
Target Population
Patients with COVID-19, including hospitalized patients and those with comorbidities
Care Setting
Hospital and outpatient settings in the United States
Key Highlights
No sufficient evidence of serious adverse events (SAEs) associated with antivirals and spike protein receptor-binding monoclonal antibodies.
Tocilizumab may increase risk of neutropenia and infections in hospitalized COVID-19 patients.
Convalescent plasma may be linked to thrombotic events, bleeding, and infections especially in patients with hematologic cancers.
Guideline-Based Recommendations
Diagnosis
Use controlled studies with placebo or usual care comparison groups to assess adverse events.
Consider background rates of adverse events due to COVID-19 infection and comorbidities.
Management
Prescribe FDA-authorized COVID-19 treatments as clinically indicated.
Exercise caution and monitor for neutropenia and infections when using tocilizumab.
Be vigilant for thrombotic and bleeding events when administering convalescent plasma, especially in hematologic cancer patients.
Monitoring & Follow-up
Active monitoring for serious adverse events including neutropenia, infections, thrombotic and bleeding events.
Use Common Terminology Criteria for Adverse Events (CTCAE) level 3 or higher to classify severity.
Maintain vigilance for rare and potentially significant toxicities in clinical practice.
Risks
Potential neutropenia and infections with tocilizumab in hospitalized patients.
Thrombotic, bleeding, and infectious complications with convalescent plasma in patients with hematologic cancers.
Confounding of adverse events by severe COVID-19 infection and comorbidities.
Patient & Prescribing Data
Patients hospitalized with COVID-19 and those with hematologic cancers
Antivirals and monoclonal antibodies generally show no increased risk of serious adverse events; tocilizumab and convalescent plasma require monitoring for specific risks.
Clinical Best Practices
Use treatments authorized by the FDA based on clinical indication and patient risk profile.
Employ active adverse event collection methods rather than passive reporting.
Interpret adverse events in context of underlying COVID-19 disease severity and comorbidities.
Include at least one US site in clinical studies to ensure applicability for US populations.
Apply rigorous definitions of serious adverse events consistent with US regulatory standards.
by Margaret A Maglione, Jeffrey D Klausner, Patricia K Wirnkar, Ivan Fallarme, Rozhin Lak, Kimny Sysawang, Ning Fu, Sachi Yagyu, Aneesa Motala, Danica Tolentino, Susanne Hempel
