Guidance for Treatment of Covid-19 in Adults and Children

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Guidance for Treatment of Covid-19 in Adults and Children GUIDANCE FOR TREATMENT OF COVID-19 IN ADULTS AND CHILDREN Patient population: Adults and pediatric patients with COVID-19 infection, who are admitted on an inpatient floor or to the intensive care unit. Key points: Details regarding isolation/precautions, personal protective equipment, patient movement, family/visitor policy, and cleaning/disinfection can be found here. Clinical symptoms: Range from asymptomatic, uncomplicated upper respiratory tract viral infection to pneumonia, acute respiratory distress syndrome (ARDS), sepsis, and septic shock (Table 1) Diagnosis: See current COVID-19 testing recommendations. Treatment: Based on data from several randomized control trials, Remdesivir may provide a modest benefit in a subgroup of patients hospitalized with COVID-19. See further details regarding patient populations (see below) and Table 2. Table 1. Potential Treatment Recommendations by Severity of Disease for Patients 18 Years or Older Most COVID-19 therapeutics have not been studied in children under 18. The below treatment recommendations may apply to some children, however should be addressed on a case-by-case basis and discussed with Pediatric Infectious Diseases. See specific sections for further details Disease severity Potential Treatment Recommendations (per ID consult discretion based on details in Table 2) Post-exposure prophylaxis • See Post-Exposure Prophylaxis Guidelines No supplemental oxygen • Supportive care • Monoclonal Antibodies may be an option in certain high-risk patients (see eligibility criteria in Table 2) admitted for reasons other than COVID-19 who have mild to moderate symptoms of COVID-19 Low flow supplemental oxygen • Supportive care • Dexamethasone (Exception: Minimal supplemental oxygen (1-2 L) in adults with <7 days of symptoms—uncertain benefit) • Remdesivir High flow supplemental oxygen or non- • Supportive Care invasive mechanical ventilation • Dexamethasone • Tocilizumab (NOTE: currently on shortage and not available for treatment of COVID-19 in patients 18 years an older. Baricitinib is the preferred replacement) • Remdesivir (uncertain benefit) Mechanical ventilation or ECMO • Supportive care • Dexamethasone • Tocilizumab (NOTE: currently on shortage and not available for treatment of COVID-19 in patients 18 years an older. Baricitinib is the preferred replacement) Table 2: Therapeutic agents dosing, duration, and details for treatment of COVID-19 Therapeutic Agents Dosing & Duration Comments Remdesivir Adult dosing: • Please page 30780 for approval prior to 200 mg IV load, then 100 first dose of remdesivir between 7 AM Patients not hypoxic and those mg IV q24h and 11 PM (7 days a week). requiring mechanical ventilation or ECMO will not meet the below criteria Pediatric dosing*: • ID consult is recommended for the because existing data does not 3.5 kg to <40 kg: following reasons: demonstrate that remdesivir confers a 5 mg/kg IV load, then o Pediatric patient clinical benefit in these patients (clinical 2.5 mg/kg q24h o Question about Remdesivir should recovery or mortality). Exceptions to the ≥40 kg: be initiated/ continued below criteria may be considered on an 200 mg IV load, then o Patient does not meet criteria for individualized basis. 100 mg IV q24h remdesivir but unique clinical circumstances warrant ID Guidelines for Use: Patients should Duration: evaluation for treatment meet criteria a & b. 5 days or until hospital o Patient/family request a. Laboratory confirmed SARS-CoV-2 discharge whichever infection by PCR from comes first. Patients • CrCl <30 mL/min is not a nasopharyngeal or respiratory started on remdesivir and contraindication to remdesivir. The risk sample and ≤14 days of symptoms progress to requiring of cyclodextrin accumulation to a toxic b. Severe COVID-19 on admission or higher level of oxygen level with 5 days of therapy is small & during hospitalization: Requires support (i.e. mechanical benefit likely outweighs risk supplemental oxygen, high-flow ventilation) should still • Increased LFTs: daily monitoring of nasal cannula*, or non-invasive complete a course of hepatic function is recommended. The mechanical ventilation* remdesivir risk of hepatotoxicity with a baseline AST/ALT >5x ULN is not known due to *HFNC and NIMV are included as patient exclusion from clinical trials; possible indications for remdesivir, but *pediatric dosing of remdesivir weigh benefit versus risk it is uncertain if remdesivir confers a is taken from the WHO recommendations for clinical benefit among patients treatment of Ebola virus, as no • Patients <12 years or ≥3.5 kg to <40 kg requiring this level of O2 support specific dosing can qualify under EUA: recommendations exist for o Healthcare Providers must review Patients < 18 years COVID-19. Remdesivir is not Fact Sheet for Healthcare Providers Remdesivir is generally indicated for authorized for patients <3.5 kg. o Patient/caregiver should be patients 12-17 years and ≥40 kg who informed of potential risks/benefits meet the above criteria. For patients and extent to which such <12 years or <40 kg, remdesivir is risks/benefits are unknown available through EUA; discuss with o Patient/caregiver should be Pediatric Infectious Diseases. informed of alternative treatments Remdesivir use is not authorized for o Provide the patient/caregiver a patients <3.5 kg. copy of the Fact Sheet for Parents and Caregivers o Document in the medical chart the information discussed/provided to the patient/caregiver Page 2 of 9 Therapeutic Agents Dosing & Duration Comments Dexamethasone Adult dosing: Weigh risks/benefits of use on a case-by- 6 mg PO or IV q24h case basis in patients with: Patients 18 years and older: • Active bacterial or fungal infection 1. Recommended in patients with Pediatric dosing*: • Diabetic ketoacidosis COVID-19 who require mechanical 0.15 mg/kg/dose IV q24h • Baseline immunosuppression ventilation or ECMO (max: 6 mg/dose) Not recommended in the following 2. Recommended for patients on Duration: patients: supplemental oxygen. The benefit Maximum 10 days, or until • Not requiring supplemental oxygen. (In of dexamethasone is uncertain in discharge RECOVERY, those had a trend towards adults on minimal levels of worse outcomes). supplemental oxygen (1-2L) with Shorter duration is • No longer COVID-19 PCR positive, but <7 days of symptoms. Decisions reasonable to consider in remain intubated. (In RECOVERY, should be individualized in such patients who have patients were randomized after patients with consideration of improved rapidly or are admission; the risk/benefit of disease severity in conjunction experiencing adverse alternative approaches later in the with risks and benefits of events from steroids. The disease course is unknown). glucocorticoid therapy. median duration of therapy in the RECOVERY Pregnancy, breastfeeding: This recommendation is based on the trial was 6 days. • Consult OB for gestational age of RECOVERY RCT, NIH and IDSA viability. Alternatives may be treatment guidelines for patients with *Pediatric dosing is based prednisone 40 mg PO daily or COVID-19 (see references) on extrapolation from the hydrocortisone 80 mg IV BID. adult dose and the Patients <18 years: RECOVERY protocol but Dexamethasone is a CYP3A4 substrate, as Patients <18 years were not has not been established such drug interactions should be assessed represented in the RECOVERY RCT and for COVID-19 prior to use. Alternatives less prone to the mean participant age was 66 interactions are prednisone 40 mg PO daily, years. It is not known if the benefit of methylprednisolone 32 mg IV daily, or dexamethasone will extend to children hydrocortisone 80 mg IV BID. with COVID-19 who require oxygen, or if there is even the potential for harm, Potential adverse events: as seen in adults who did not require • Increased risk for infection oxygen. However, it is reasonable to • Hyperglycemia consider dexamethasone for children • Peripheral edema who require mechanical ventilation, or • Increased appetite high levels of oxygen support (e.g., • Insomnia, irritability, delirium high-flow oxygen or noninvasive ventilation), particularly if they are In the setting of a dexamethasone rapidly progressing toward mechanical shortage, an equivalent total daily dose of ventilation. Recommend consultation an alternative glucocorticoid to with Pediatric Infectious Diseases. dexamethasone 6 mg daily can be used (e.g., methylprednisolone 32 mg (<40 kg: 0.8 mg/kg) daily or prednisone 40 mg (<40 kg: 1 mg/kg) daily) Page 3 of 9 Therapeutic Agents Dosing & Duration Comments SARS-COV-2 Neutralizing Antibodies Adult and Pediatric Dosing ID approval is required. ID consultation is Available via FDA issued Emergency Use recommended and can only be ordered by Authorization Casirivimab 600 mg IV x1 ID consultants + Imdevimab 600 mg IV x1 Casirivimab + Imdevimab See Post-exposure prophylaxis guidelines Note: Monoclonal if patient has been exposed, but is not Eligibility Criteria antibodies are not symptomatic Patients with mild or moderate COVID-19 authorized for patients <12 who meet criteria #1-4 AND #5 or #6 years or <40 kg, regardless At the discretion of the ID consultant, 1) Admitted for a reason not related to of other indications monoclonal antibody therapy may be given COVID for patients not meeting the eligibility 2) No requirement for supplemental criteria listed but who are still deemed high oxygen (or no increase from baseline risk for progression to severe disease. supplemental oxygen) 3) Symptoms ≤10 days Healthcare Providers must review: 4) Not received convalescent
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