COVID Disease — Summary — Clinical Pathway: All Settings
Summary of Recent Updates to COVID-19 Therapies (9/13/2022)
Background: Multiple changes have been made to the COVID-19 treatment recommendations in response to evolving data surrounding the omicron variant, as well as FDA authorization of a several novel therapies. This document summarizes key changes and will be updated frequently.
- Modified recommendations for immunomodulators in critically ill/rapidly deteriorating hospitalized children to include:
- Introduced two separate tables detailing treatment recommendations for hospitalized children and non-hospitalized children
- Updated to reflect changes in ordering/monitoring instructions for remdesivir to reflect the FDA approval of the drug, including:
- Written consent is no longer required to prescribe remdesivir.
- Only a baseline CMP is recommended routinely to check creatinine and AST/ALT; daily LFTs are not required while on therapy, except if there is a clinical concern for hepatotoxicity (e.g., patients on concurrent hepatotoxic medications, baseline abnormal LFTs).
- Baseline CBC and PT/INR is no longer required, obtain as clinically indicated.
- Written consent is no longer required for use of Paxlovid™ or molnupiravir. Prescribers must use the respective “dot” phrases in Epic and document verbal informed consent, including the name of the consenting party.
- Updated to reflect the availability of nirmatrelvir/ritonavir (Paxlovid) in the CHOP outpatient pharmacy. Prescribers may now send Paxlovid prescriptions to this site. All other processes for Paxlovid prescribing remain the same per the nirmatrelvir/ritonavir (Paxlovid) ordering instructions.
- Per FDA guidance , sotrovimab is no longer authorized in the US for treatment of acute COVID-19 and will therefore will no longer be available at CHOP.
- Providers should consider treatment with nirmatrelvir/ritonavir (Paxlovid) for high risk patients. See Therapies by Illness Severity and nirmatrelvir/ritonavir (Paxlovid) pages for additional information.
- Expanded eligibility for sotrovimab to include additional populations of unvaccinated, high risk patients.
- Modified the process for referring patients for sotrovimab to include placing an Epic Consult order – please review the prescribing steps on the sotrovimab page, which is a change in process effective 2/14/2022
- Created a decision tree to prioritize outpatient therapies for adolescent patients, when indicated
- Added content related to nirmatrelvir/ritonavir (Paxlovid), which is an oral antiviral medication used for treatment of select high risk outpatients ≥ 12 years old and ≥ 40 kg with mild-moderate COVID-19.
- Added content related to molnupiravir, another oral antiviral medication, which is available only for select high risk outpatient adults ≥ 18 years and older. Molnupiravir is substantially less effective than nirmatrelvir/ritonavir (Paxlovid) and is authorized only when no other treatment options are available.
- Updated the Therapies by Illness Severity to reflect use of oral antiviral drugs
- Clarified that all treatment recommendations pertain to patients whose current clinical symptoms are attributable to COVID-19; in the case of remdesivir and steroids, patients should have clinical or radiographic evidence of lower respiratory tract disease attributable to COVID-19. In particular:
- Emphasized that remdesivir and steroids are not routinely recommended for patients with bronchiolitis. There are no data that remdesivir or steroids are beneficial in this group, and bronchiolitis is generally a self-limited illness, with multifactorial reasons a patient may have a supplemental oxygen requirement.
- Emphasized that remdesivir is not routinely recommended for patients with asthma who require supplemental oxygen, given that their supplemental oxygen requirement is multifactorial and may not be related to COVID-19 lower respiratory tract disease.
- Updated to indicate that remdesivir is not available for outpatients at CHOP. Please review remdesivir section for rationale.
- Revised recommendations for hospitalized patients with mild disease (e.g., those admitted to the hospital for non-COVID-19 indications who develop mild respiratory symptoms without an O2 requirement) to indicate that remdesivir may be considered in high risk, unvaccinated or immunocompromised individuals within 7 days of symptom onset.
- Revised recommendations for hospitalized patients requiring supplemental oxygen that remdesivir should be used only within 10 days of symptom onset.
- Clarified that ID consultation is not required for all patients receiving remdesivir; Abx Approval is required for use of remdesivir.
- Clarified that sotrovimab may be administered within ≤ 5 days of symptoms in eligible patients (not < 5 days)
- We suggest that individuals managing COVID-19 patients review the Therapies by Illness Severity page and information on each drug linked from this table.
- Evusheld is not yet available to CHOP patients. More information will become available over the coming weeks as to when eligible patients may be able to receive Evusheld. No action is required at this time on the part of patients or providers to access Evusheld once it is available.
- Paxlovid and molnupiravir are being distributed to select pharmacies in the Philadelphia area. Additional information for CHOP prescribers will be available the week of 1/10/22.
- Updated to indicate that monoclonal antibody infusions have resumed as of 1/5/22. Only sotrovimab will be offered at CHOP, as it is the only monoclonal antibody with activity against the omicron variant.
- Sotrovimab can be considered on a case by case basis for immunocompromised individuals and select high risk, unvaccinated patients. See sotrovimab page for further information.
- The combination of nirmatrelvir-ritonavir (Paxlovid) is an oral antiviral medication that received Emergency Use Authorization (EUA) status from the FDA for adolescents and adults age > 12 years and > 40 kg for the treatment of mild to moderate SARS-CoV-2 infection who are at high risk of progression to severe SARS-CoV-2 infection or death. Providers are not currently able to prescribe Paxlovid as it is not available in pharmacies, including the CHOP pharmacy. Guidance will be updated frequently as more information becomes available regarding availability, and CHOP experts will issue recommendations for use of this drug. See Paxlovid talking points.
- Molnupiravir is an oral antiviral agent that received EUA status from the FDA for adults > 18 years of age for the treatment of mild to moderate SARS-CoV-2 who are at high risk of progression to severe SARS-CoV-2 infection or death. This drug appears to be less effective than nirmatrelvir-ritonavir (Paxlovid). Providers are not currently able to prescribe molnupiravir as it is not available in pharmacies, including the CHOP pharmacy. Guidance will be updated frequently as more information becomes available regarding availability, and CHOP experts will issue recommendations for use of this drug.
- The monoclonal antibodies bamlanivimab-etesevimab and casirivimab-imdevimab are not active against the omicron variant. Use of these agents at CHOP for the treatment or post-exposure prophylaxis of SARS-CoV-2 will be halted per public health recommendations as of 12/24/2021 given that the majority of SARS-CoV-2 is the omicron variant. See Monoclonal Antibody section for additional information.
- Sotrovimab is a monoclonal antibody with activity against the omicron variant used for treatment of COVID-19. As of 12/23/2021, no sotrovimab is available at CHOP. The status of sotrovimab supply will be determined weekly and sotrovimab will be made available to as many eligible patients as possible. However, the supply of sotrovimab is extremely limited. See Monoclonal Antibody section for additional information.
- Evusheld is a monoclonal antibody used for pre-exposure prophylaxis in select high risk patients and in patients who cannot receive a COVID-19 vaccine. It is not for individuals who refuse vaccination. As of 12/23/2021, no Evusheld is available at CHOP. Once supply is received, Evusheld will be made available to as many eligible patients as possible. However, the supply of Evusheld is extremely limited and not all eligible individuals will be able to receive Evusheld right away. See Talking Points/FAQ Regarding PReP for additional information.
- Remdesivir is an antiviral medication that is administered by IV infusion. Although there are adult data demonstrating reductions in the frequency of hospitalization or 28-day mortality in patients with mild-moderate COVID-19 treated with 3 days of remdesivir, there are no pediatric data supporting a benefit of this therapy in ambulatory patients. Given the lack of pediatric data and the overall mild course of illness experienced in children with COVID-19, remdesivir is not recommended in outpatients. There are no changes to the recommendations surrounding use of remdesivir for hospitalized children. See remdesivir section for additional information.