The Penn Medicine COVID-19 Therapeutics Committee-Reflections on a Model for Rapid Evidence Review and Dynamic Practice Recommendations During a Public Health Emergency

Abstract

The Penn Medicine COVID-19 Therapeutics Committee-an interspecialty, clinician-pharmacist, and specialist-front line primary care collaboration-has served as a forum for rapid evidence review and the production of dynamic practice recommendations during the 3-year coronavirus disease 2019 public health emergency. We describe the process by which the committee went about its work and how it navigated specific challenging scenarios. Our target audiences are clinicians, hospital leaders, public health officials, and researchers invested in preparedness for inevitable future threats. Our objectives are to discuss the logistics and challenges of forming an effective committee, undertaking a rapid evidence review process, aligning evidence-based guidelines with operational realities, and iteratively revising recommendations in response to changing pandemic data. We specifically discuss the arc of evidence for corticosteroids; the noble beginnings and dangerous misinformation end of hydroxychloroquine and ivermectin; monoclonal antibodies and emerging viral variants; and patient screening and safety processes for tocilizumab, baricitinib, and nirmatrelvir-ritonavir.

Keywords: COVID-19; emerging pathogen; evidence-based medicine; preparedness.

Figure 1.

The Penn Medicine COVID-19 Therapeutics Committee outpatient treatment algorithm for coronavirus disease 2019 (COVID-18) after loss of US Food and Drug Administration (FDA) emergency use authorization for all severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies. This algorithm was published 1 December 2022 after revocation of the FDA emergency use authorization for bebtelovimab, the last remaining available SARS-CoV-2 monoclonal antibody at that time. The algorithm assists in the consideration of ambulatory treatment with nirmatrelvir-ritonavir, molnupiravir, or remdesivir, taking into account patient-level risk factors, drug-specific contraindications, and operational realities. It is important to note that this algorithm is presented as an example of guideline communication, not as representing current recommendations, which remain dynamic. (Original publication location and current recommendations are available at https://www.uphs.upenn.edu/antibiotics/COVID19.html. CYP3A, Cytochrome P450 3A).