CHKD Treatment Guidance for COVID-19 in Children

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CHKD Treatment Guidance for COVID-19 in Children
CHKD Treatment Guidance for COVID-19 in Children

               ***This guideline will be frequently updated. Ensure you are utilizing the most recent version.***

Patient population: Patients with suspected or confirmed COVID-19 infection who are admitted to an inpatient floor or the intensive
care unit.

Key Points: Numerous studies suggest that COVID-19 disease manifestations are significantly less severe in children. However,
several reports exist that describe children with COVID-19 who required an intensive level of care.23

Clinical symptoms: Symptoms range from uncomplicated upper respiratory tract viral infection to pneumonia, acute respiratory
distress syndrome (ARDS), sepsis, and septic shock (Table 1). No specific data is available establishing risk factors for severe
COVID-19 disease in children.23

COVID-19 Treatment:
       Supportive Therapy: Supportive treatment including sufficient fluid and calorie intake, and additional oxygen
        supplementation should be used in the treatment of children infected with COVID-19. The aim is to prevent ARDS, organ
        failure, and secondary nosocomial infections. If bacterial infection is suspected, broad-spectrum antibiotics may be used.22
        NSAID use is not contraindicated and has not been proven to have any added benefit or adverse outcomes in patients with
        COVID-19.
       Antiviral Therapy: Currently no drug has been proven to be safe and effective for treating COVID-19. There is insufficient
        data to recommend either for or against the use of any antiviral or immunomodulatory therapy in patients with COVID-19
        who have mild, moderate, severe, or critical illness. Treatment should be considered as outline in (Figure 1). All agents
        described in Table 4 are considered investigational or expanded access/EUA, and the decision to use should be made only
        after weighing the risks and benefits in addition to clinical status, comorbidities, and interacting medications.22-23
       Pre/Post-exposure prophylaxis: No drugs have been found to be effective and are not recommend by the COVID-19
        Treatment Guidelines.23
Anticoagulation: COVID-19 is associated with an increased risk of venous thromboembolism (VTE) in adults. Due to this risk,
routine use of pharmacologic prophylaxis or therapeutic anticoagulation is utilized unless contraindicated. Currently there are no
specific recommendations for pediatric patients with COVID-19.15-21 Pediatric confirmed COVID-19 hospitalized patients should be
assessed based on risk factors as outlined below:
     1) Consider Hem/Onc consult for risk assessment and recommendations.
     2) Individual VTE risk factors should be evaluated on admission and reassessed every 48-72 hours for the duration of the
          hospitalization.
     3) Enoxaparin prophylaxis is recommended in adult patients with confirmed COVID-19 unless contraindicated.
     4) Enoxaparin prophylaxis should be strongly considered in pediatric patients with confirmed COVID-19 unless
          contraindicated.
     5) An assessment of bleeding risks verses benefit should be completed on each patient (Table 3).
     6) Alternative methods of prophylaxis such as early ambulation or mechanical prophylaxis should be considered in
          contraindicated patients and all COVID-19 pediatric patients, if applicable. 15-21

Due to increased demand and drug shortages, hydroxychloroquine now requires ID approval prior to administration to
ensure our supply is utilized to the most at-risk patients.
     If an order for hydroxychloroquine is entered it will NOT be verified by a pharmacist until ID approval is confirmed and
        documented.
     ID should be paged to obtain approval by the ordering provider once a patient is identified and meets the requirements for
        treatment, see (Figure 1).
     Documentation of approval may occur via:
             o Verbal confirmation of ID attending approval, date, and time, from the ordering provider.
             o Direct confirmation of approval from the ID attending to the pharmacist.
     If ID approval is not obtained or is rejected, hydroxychloroquine cannot be verified or dispensed.
     The pharmacists will document the approving ID attending, date, and time on the active order.

Version 1.5-May 4, 2020
Table 1. Clinical symptoms associated with COVID-19 infection
   Symptoms                       Description
                                  Uncomplicated upper respiratory tract viral infection with nonspecific symptoms including:
     Uncomplicated Illness                 Fever, cough, sore throat, nasal congestion, malaise, headache, muscle pain
                                  Without signs of dehydration, sepsis, or shortness of breath
                                  Non-severe pneumonia presenting with cough or difficulty breathing +tachypnea
        Mild Pneumonia
                                  Without signs of severe pneumonia
                                  Adolescent: fever or suspected respiratory infection + one of the below:
                                           RR > 30 breaths/min
                                           Severe respiratory distress
                                           SpO2 < 90% on room air
       Severe Pneumonia
                                  Child: cough of difficulty breathing + one of the below:
       Diagnosis is clinical
                                           Central cyanosis
                                           SpO2 < 90%
                                           Severe respiratory distress
                                           Clinical signs of pneumonia + inability to breast feed or drink, lethargy, convulsions
                                  New or worsening respiratory symptoms within one week of known clinical insult
             ARDS                 Chest imaging consistent with ARDS
                                  Respiratory failure not explained by cardiac failure or fluid overload
             Sepsis               Diagnosis made clinically
          Septic Shock            Diagnosis made clinically
  Source: World Health Organization

Table 2. Criteria for risk high-risk of cytokine storm10
    1 or more of the below     Description
    Serum IL-6                 ≥3x upper normal limit
    Ferritin                   >300 ug/L with doubling in 24 hrs
    Ferritin +                 >600 ug/L at presentation
    LDH                        >250
    D-dimer                    Elevated

Table 3. Bleeding Risk Factors: 15-21
     Bleeding Risk Factors       Description
                                 Intracranial hemorrhage
     Not Recommended
                                 Active bleed
                                 Intracranial mass
                                 Lumbar puncture w/in 24 hours
     Consider with caution
                                 Coagulopathy
                                 Neurosurgical procedure w/in 24 hours

Version 1.5-May 4, 2020
Figure 1. Treatment Algorithm in Children: Dosing per Table 4

             Outpatient
             Otherwise healthy child with                                   Awaiting COVID19 results                Supportive Care
             suspected COVID19                                                                                          ONLY
                Including high risk*
                                                                                                                     Supportive Care
                                                                       Confirmed (+) COVID19 test
                                                                                                                         ONLY

     Inpatient: Non-ICU
     Otherwise healthy child with suspected
     COVID19 + clinical symptoms including:                                Awaiting COVID19 results               Supportive Care
        Uncomplicated illness                                                                                        ONLY
        Mild pneumonia

                                                                         Confirmed (+) COVID19 test                 Supportive Care
                                                                                                                        ONLY

      Inpatient Non-ICU: High Risk*
      COVID19 + clinical symptoms including:                                                                               Supportive Care +
                                                                            Awaiting COVID19 results
         Mild pneumonia                                                                                              Consider Hydroxychloroquine

      Consider baseline and daily interleukin levels

                                                                                                                          Supportive Care +
                                                                          Confirmed (+) COVID19 test
                                                                                                                     Consider Hydroxychloroquine

     Inpatient (PICU/NICU)
     COVID19 + clinical symptoms including:
        Severe pneumonia                                                                                                      Supportive Care +
                                                                            Awaiting COVID19 results
        ARDS                                                                                                             Consider Hydroxychloroquine
        Sepsis/septic shock

     Consider baseline and daily interleukin levels
                                                                           Confirmed (+) COVID19 test

                          Mechanically Ventilated                                                         NOT Mechanically Ventilated

             Evaluate Remdesivir Eligibility:
                 Refer to CHKD Remdesivir policy                                        High risk of severe disease                 Supportive Care +
                 Policy located on COVID-19 kdnet                                                     +                            Hydroxychloroquine
                                                                                                                    ∆
                 If eligible, Consult ID ASAP to initiate process                      High risk of cytokine storm                  (+/-) Azithromycin
                                                                                                      OR
                                                                                      Rapidly worsening gas exchange
                                                                                                       +
                                                                                           Pulmonary infiltrates
       Remdesivir Approved                     Remdesivir Exclusion                                    +
                                                                                       SpO2 ≤ 93% on RA or > 6L/min

         Supportive Care +
            Redesivir Ψ                                                              Supportive Care +
       Hydroxychloroquine +                                                        Hydroxychloroquine +
                            ∆
       Consider Tocilizumab                                                        Consider Tocilizumab ∆
                                                                                     (+/-) Azithromycin
* High Risk- Immunocompromised, cardiovascular, pulmonary, hepatic, renal, hematologic, neurologic conditions
∆
   See Table 2
 Ψ
   Shipment requires 1-3 days
     Version
   Consider QTc1.5-May     4, 2020
                 prolongation risk with combo therapy (Figure 2)
Table 4. Agents under investigation for treatment of COVID-19:
     1st Line Antiviral therapy                           Dosing & Duration                                         Comments
Hydroxychloroquine                    Adult dosing (≥18 years):                                  Adverse events:
(PO only)                                400mg BID x 2 doses (load) day 1, then 200 mg BID         Retinopathy rash, nausea, glucose
                                          days 2-5                                                   fluctuations, and diarrhea. GI symptoms
   Empiric therapy for high risk &                                                                 May be mitigated by taking with food
    critical patients                 Pediatric dosing9 ( 50Adult       400mg BID                200 mg BID        May start while awaiting G6PD results
                                      LD-Loading Dose
   Follow QT evaluation (Figure      MD-Maintenance Dose                                        Additional Comments:
    2) if combination therapy                                                                        Suspension may be given via NG tube
                                      Duration:                                                      Separate from antacids by at least 4 hours
Infectious Disease Restricted            5 days                                                     May be crushed
                                         Extended ventilation or profound immunosuppression         Fetal ocular toxicity in animal studies
                                          duration may be extended                                   Excreted into breast milk
Tocilizumab                           Adult Dosing (≥18 years):                                  Tocilizumab adjunctive therapy may improve
                                         50-59 kg: 400 mg IV                                    oxygenation & time to symptom resolution in
   Consider adding to antiviral         60-85 kg: 600 mg IV                                    high risk patients with cytokine storm
    therapy for patients meeting         >85 kg: 800 mg IV
    criteria (Figure 1)                                                                          Contraindications:
                                      Pediatric Dosing (
Azithromycin                                Pediatric dosing (
8.    Gautret et al. (2020) Hydroxychloroquine and azithromycin as a treatment of COVID‐19: results of an open‐label non‐
          randomized clinical trial. International Journal of Antimicrobial Agents – In Press 17 March 2020
          DOI: 10.1016/j.ijantimicag.2020.105949
    9.    Michael Cohen-Wolkowiez, MD PhD; Anil Maharaj, PhD; Huali Wu, PhD, et al. Pediatric Trials Network (PTN)
          Hydroxychloroquine Pediatric Dosing Guidelines to Target Treatment of SARS-CoV-2 Virus. 20 March, 2020
    10.   Giwa AL, Desai A, Duca A. Novel 2019 coronavirus SARS-CoV-2 (COVID-19): An updated overview for emergency
          clinicians. Emerg Med Pract. 2020 May 1;22(5):1-28. Epub 2020 Mar 24
    11.   Chen C, Zhang XR, Ju ZY, et al. Advances in the research of cytokine storm mechanism induced by corona virus disease
          2019 and the corresponding Go to www.ebmedicine.net/COVID-19 for updates to this article, podcasts and videos, and more
          immunotherapies. Zhonghua Shao Shang Za Zhi 2020;36:E005-E005 (Basic science review)
    12.   Yonggang Zhou BF, Xiaohu Zheng et al. Pathogenic T cells and inflammatory monocytes incite inflammatory storm in
          severe COVID-19 patients. 2020
    13.   Mehta P, McAuley DF, Brown M, et al. COVID-19: consider cytokine storm syndromes and immunosuppression. The
          Lancet
    14.   Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China:
          a retrospective cohort study. Lancet (London, England) 2020:S0140-6736(0120)30566-30563 (Retrospective cohort study;
          191 patients)
    15.   Meier KA, Clark E, Tarango C, Chima RS, Shaughnessy E. Venous thromboembolism in hospitalized adolescents: an
          approach to risk assessment and prophylaxis. Hospital pediatrics. 2015;5(1):44-51
    16.    Newall F, Branchford B, Male C. Anticoagulant prophylaxis and therapy in children: current challenges and emerging
          issues. Journal of thrombosis and haemostasis : JTH. 2018;16(2):196-208
    17.   Mahajerin A, Webber EC, Morris J, Taylor K, Saysana M. Development and Implementation Results of a Venous
          Thromboembolism Prophylaxis Guideline in a Tertiary Care Pediatric Hospital. Hospital pediatrics. 2015;5(12):630-636
    18.   Hanson SJ, Punzalan RC, Arca MJ, et al. Effectiveness of clinical guidelines for deep vein thrombosis prophylaxis in
          reducing the incidence of venous thromboembolism in critically ill children after trauma. The journal of trauma and acute
          care surgery. 2012;72(5):1292-1297
    19.   Faustino EV, Raffini LJ. Prevention of Hospital-Acquired Venous Thromboembolism in Children: A Review of Published
          Guidelines. Frontiers in pediatrics. 2017;5:9
    20.   Kim SJ, Sabharwal S. Risk factors for venous thromboembolism in hospitalized children and adolescents: a systemic review
          and pooled analysis. Journal of pediatric orthopedics Part B. 2014;23(4):389-393
    21.   Parasuraman S., Goldhaber S. Venous Thromboembolism in Children. Circulation. 2006;113:e12-e16
    22.   Zimmerman P., Curtis N. Coronavirus Infections in Children Including COVID-19: An Overview of the Epidemiology,
          Clinical Features, Diagnosis, Treatment and Prevention Options in Children. Pediatr Infect Dis J. 2020;XX:00–00
    23.   Panel on COVID-19 Treatment. COVID-19 Treatment Guidelines. Available at
          https://www.covid19treatmentguidelines.nih.gov/overview/ Accessed (5/2020)

  Infectious Disease Approval: 3/20/2020                 Created by: Sarah Parsons Pharm.D., BCPPS & Laura Sass M.D.
  Originated: 03/20/2020                                 Last Revised: 05/04/2020
  Revision History:03/23/20 14:45
  03/30/20: updated Lopinavir/ritonavir dosing and duration, remove azithromycin from combination early initiation, added QT
  monitoring recommendations and risks, NSAID statement
  4/3/20: Remdesivir reference to guideline, included reference for cytokine storm
  4/9/20: NG administration for hydroxychloroquine, Remdesivir added to figure 1, azithromycin changed to (+/-) in figure 1. Tables
  renumbered for organization, VTE prophylaxis guidance-Reviewed by Eric Lowe MD & Jessica Price PharmD
  5/4/20: Updated information on disease process in children, added EUA to remdesivir, changed to consider hydroxychloroquine to
  the treatment algorithm. Added new references. Removed Lopinavir-Ritonavir
The recommendations in this guide are meant to serve as treatment guidelines for use at The Children’s Hospital of The King’s
Daughters. As a result of ongoing research, practice guidelines may change from time to time. The authors of these guidelines have
made all attempts to ensure the accuracy based on current information; however, due to ongoing research, users of these guidelines are
strongly encouraged to confirm the information through an independent source.

Version 1.5-May 4, 2020
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