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Clinical Reference Group SBAR: Therapies for COVID-19

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Clinical Reference Group SBAR: Therapies for COVID-19 UPDATED: September 8th, 2021 The British Columbia COVID-19 Therapeutics Committee (CTC) meets bi-weekly to discuss the most current research on the use of therapies in the management of COVID-19. Situation SARS-CoV-2 (previously named 2019-nCoV), the virus that causes the clinical illness COVID-19, is a novel RNA virus belonging to the coronavirus family. With over 221 million cases worldwide, various treatments are being used clinically or undergoing evaluation. In preparation for in-patient treatment of COVID-19 at BC’s health care facilities, the COVID Therapeutics Committee has reviewed the evidence for these therapies and made recommendations concerning their use in consultation with various groups such as Infectious Diseases, Medical Microbiology, Intensive Care, Internal Medicine, Emergency Medicine, Hospitalists, Long Term Care and Pharmacy. The COVID Therapeutics Committee has also provided general treatment guidelines for anti-infective use in the setting of viral pneumonia for in- patients. As this is an evolving situation, we are making the necessary amendments to this SBAR along with up-to-date recommendations weekly, and as emerging information becomes available. Background Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV-1). SARS-CoV-2, the virus responsible for the COVID-19 pandemic, is a non-segmented, positive sense RNA virus most closely related to SARS-CoV-1, with 82% nucleotide identity. There have been over 221 million cases of COVID-19 to date, with a global case fatality rate of ranging between 2% to 10% depending on the country and criteria for testing. Remdesivir is currently the only antiviral agent conditionally approved in Canada for treatment of COVID-19. Certain immunomodulatory treatments have been studied and shown positive results, for example corticosteroids and IL-6 inhibitors such as tocilizumab, while others continue to be investigated in clinical trials. Concomitantly, several well-designed studies have shown various therapies to have no effect or pose safety concerns. Agents of particular interest currently include monoclonal antibodies against the spike protein, as well as oral direct acting antivirals currently in the development pipeline. The most significant advancement in COVID-19 therapeutics is dexamethasone and tocilizumab, with survival benefit, followed by data surrounding anticoagulation for hospitalized patients. While less impactful, colchicine, inhaled budesonide and remdesivir have been shown to decrease time to recovery or improve symptoms in a variety of patient populations. As of January 16, 2021, the Cochrane COVID-19 Study Register lists over 4300 interventional trials. A large proportion of the discussion regarding potential treatment for COVID-19 within the medical community has been occurring through non-academic channels such as social media, blogs or the news. A scientific literature search of potential non-vaccine therapies for COVID-19 and other coronaviruses (search strategy below) resulted in over hundreds of publications. The following pharmaceutical agents are discussed in detail below (see “Assessment”): 1. corticosteroids 2. tocilizumab, sarilumab 3. therapeutic anticoagulation and venous thromboembolism (VTE) prophylaxis 4. colchicine 5. remdesivir# 6. lopinavir/ritonavir (Kaletra®) 7. chloroquine or hydroxychloroquine 8. oseltamivir 9. ribavirin and interferon 10. ivermectin# 11. ascorbic acid and vitamin D 12. biologics/small molecules (anakinra, baricitinib, ruxolitinib) # 13. convalescent plasma#, intravenous immunoglobulin (IVIG) and monoclonal antibodies/antibody cocktails 14. antibiotics 15. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 16. Angiotensin Converting Enzyme (ACE) inhibitors and Angiotensin Receptor Blockers (ARBs) 17. SSRIs # Denotes that a clinical trial of named therapy is currently planned or underway in British Columbia. Links below for registered trials in Canada and British Columbia. Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-clinical- trials/list-authorized-trials.html British Columbia: https://bcahsn.ca/covid-19-response/inventory/ Articles commenting on safety of other agents, for example Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Angiotensin Converting Enzyme (ACE) inhibitors and Angiotensin Receptor Blockers (ARBs), in the context of COVID-19 have also been published. These topics are also discussed in detail below (see “Assessment”). Other investigational therapies that have been suggested by various medical and non-medical literature sources include ASC09, azvudine, baloxavir marboxil/favipiravir, camostat mesylate, darunavir/cobicistat, camrelizumab,niacin, thymosin, natural health products and traditional Chinese medicines. Information on these therapies are limited due to lack of data, lack of availability, or both. Detailed assessment on these therapies will be provided when credible scientific literature becomes available. Page 2 of 112 It is recognized that there may be extenuating clinical circumstances where clinicians decide to use unproven therapies when clinical trials are unavailable. In those circumstances where unproven therapies are used, the WHO has provided a standardized case record form for data collection to ensure that there is contribution to scientific research and the clinical community. Locally, in British Columbia, there is consensus between expert groups regarding treatment of COVID-19 with both unproven therapies and therapies shown to be efficacious in clinical trials through the BCCDC’s Clinical Reference Group, Provincial Antimicrobial Committee of Experts (PACE), and the clinical community. The agreement is that investigational treatments will not be used outside of approved randomized controlled trials (RCTs). This also applies to specific patients like those with immunocompromising conditions (e.g. solid organ transplant). Many BC Health Authorities have committed to enrolling in RCTs such as the CATCO study which aims to investigate the use of remdesivir in the treatment of COVID-19 in hospitalized patients. This RCT is led by Dr. Srinivas Murthy (Infectious Diseases and Critical Care) from BC Children’s Hospital and funded through the Canadian Institutes of Health Research. Several other trials are in the process of recruiting sites across Canada and are in various stages of ethics and operational approval. The BC Health Authorities are currently reviewing the local feasibility of these clinical studies on a regular basis. For recommendations pertaining to Multisystem Inflammatory Syndrome in Children (MIS-C) and COVID-19 please visit BCCDC website at: http://www.bccdc.ca/Health-Professionals- Site/Documents/COVID19_MIS-C_ClinicianGuidance.pdf For recommendations pertaining to Multisystem Inflammatory Syndrome in Adults (MIS-A) and COVID- 19 please visit BCCDC website at: https://www.cmaj.ca/content/193/25/E956 Page 3 of 112 Assessment Corticosteroids Recommendation: i) Non hospitalized patients with no oxygen requirements: In adults with mildly ill COVID-19 aged 65 and over OR aged 50 and over with underlying health conditions and within 14 days of symptom onset, inhaled budesonide 800 μg twice daily for 14 days may be considered on a case by case basis in discussion with the patient by clearly highlighting the uncertainty in the benefit of treatment, and the risks and potential adverse effects. Informed consent should be obtained and treatment initiated as soon as possible. Underlying health conditions include weakened immune system due to illness or medication; heart disease and/or hypertension; chronic lung disease; diabetes; hepatic impairment; stroke or other neurological condition; obesity or BMI above 35. ii) Hospitalized patients requiring oxygen or higher levels of respiratory support Dexamethasone 6 mg IV/PO q24h for up to 10 days is strongly recommended (RECOVERY trial), unless higher doses are clinically indicated (e.g. asthma exacerbation, refractory septic shock, history of chronic steroid use, obstetric use for fetal lung maturation). Hydrocortisone 50 mg IV q6h is recommended as an alternative (REMAP-CAP trial). If dexamethasone and hydrocortisone are not available, methylprednisolone 32 mg IV q24h or prednisone 40 mg PO daily are recommended. Inhaled budesonide Use of inhaled budesonide was prompted by the noticeable decrease in COVID-19 symptoms in patients with chronic obstructive pulmonary disease. Two trials assessed whether inhaled steroids decreased hospitalization. While both trials are limited by their design and one was stopped early because of enrollment, both demonstrated improvement in self-reported symptom duration, albeit small and not seen with more objective measures. Furthermore, the decrease in hospitalization or medical related visits remains unclear. Study details: STOIC: inhaled budesonide in the treatment of early COVID-19 ● Design: Open-label, parallel-group, phase 2, RCT ● Inclusion: Adults aged older than 18 years with symptoms of COVID-19 (new onset cough and fever or anosmia, or both) within 7 days ● Exclusion: recent use (within 7 days) of inhaled or systemic glucocorticoids or if they had a known allergy or contraindication to inhaled budesonide ● Intervention: usual care or intervention with budesonide dry powder inhaler (Pulmicort Turbuhaler, AstraZeneca,
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