Sotrovimab 500 mg by injection has at times been considered appropriate for the treatment of COVID-19 patients with mild to moderate symptoms when administered by intravenous infusion within 5 days of symptom onset. With evidence of little impact for Omicron and related variants, its use is not currently supported. Sotrovimab use is restricted and must comply with current guidelines. There is a dependency on laboratory capacity for the determination of variants which is itself subject to change. Please use the resource links below for access to current guidelines.
Clinical Requirements
Outpatients or inpatients admitted for non-COVID-19 reasons or inpatients with hospital-acquired COVID-19 if meeting ALL of the following 4 criteria:
Mild to moderate COVID-19 symptoms
Positive COVID-19 PCR test result
Able to receive treatment within 5 days of symptom onset
Confirmed not infected with BA.2 variant of SARS-CoV-2
AND
Meet 1 of the following 2 criteria:
Unvaccinated (no COVID-19 immunization) AND one or more of:
Age 55 and over
Age 18 and over with at least 1 of the following comorbidities:
Diabetes requiring medication
Obesity with BMI > 30 kg/m2
Chronic Kidney Disease (eGFR 60 ml/min/1.73 m2)
Congestive Heart Failure (NYHA class II, III or IV)
COPD
Moderate to severe asthma
Pregnancy
Immunocompromised regardless of immunization status
Transplant (solid organ or stem cell) recipients
Oncology patients receiving any chemotherapy or immunosuppressive therapy since December 2020
Inflammatory conditions (e.g., RA, Lupus, IBD, etc.) receiving any systemic immunosuppression since December 2020
Resources
Casirivimab-Imdevimab ("REGEN-COV", single 4000/4000 mg dose) may be used to treat hospitalized patients aged 12 years or older weighing at least 40 kg with acute laboratory-confirmed COVID-19, if specific conditions are met. However, this agent fails to neutralize the Omicron variant of SARS-CoV-2 and should not be used for confirmed or suspected Omicron variants or sub-variants.
Clinical Requirements
COVID-19 naive (no prior COVID-19 disease), meeting all of the following criteria:
No documented history of prior COVID-19 infection
No prior treatment with a COVID-19 neutralizing antibody (except bamlanivimab monotherapy)
No prior COVID-19 vaccination unless within 14 days of a first dose
Seronegative, based on results from a laboratory-based or rapid serology test
Immunocompromised, as defined by any of the following:
Congenital and acquired immunodeficiency, including severe combined immunodeficiency (SCID) and profound hypogammaglobulinemia
HIV infection with CD4 T lymphocyte count <200 (or less than 15%) and unsuppressed viral load
Pediatrics: 5 years or older – use CD4 count <200
Any haemotological malignancy
Within 24 months of stem cell transplant
Solid organ transplant
Current receipt of prednisone >20 mg/day (or equivalent) for more than 14 days
Pediatrics: >2 mg/kg body weight for more than 14 days
Chimeric antigen receptor (CAR) T-cell therapy
Anti-B cell therapy (current or within last 6 months), e.g., ocrelizumab, rituximab
Research Requirements
Inpatients admitted for non-COVID reasons with nosocomial COVID-19 infection and enrolled in the CATCO-NOS clinical trial (1200/1200 mg dose).
Resources
Tixagevimab and cilgavimab (Evusheld) is a combination of two long-acting antibodies that bind to the SARS-CoV-2 virus to prevent its entry into cells. In limited circumstances, it may be used for prevention of COVID-19 in Albertans who are highly immunocompromised and not able to generate their own antibodies against COVID-19 following vaccination or infection. Evusheld is not a replacement for vaccination.
Evusheld is administered through a third-party provider for outpatients, but can also be ordered for inpatients who meet eligibility criteria.
Clinical Requirements
Severely immunocompromised, unlikely to mount an adequate response to vaccination and at risk for severe outcomes from COVID-19 illness
Solid organ transplant patients meeting one of the following criteria:
Lung transplant
Received B cell depleting therapy (Rituximab), T cell depletion (ATG, Alemtuzumab), or Belatecept within the prior 6 months
In first 6 months post-transplant
Age > 60 years
Stem cell transplant or CAR-T therapy within the prior 12 months
Hematologic malignancy on a B cell depleting agent within the prior 12 months
Primary immune defects known to be associated with impaired antibody production and function (e.g., CVID, SADs, XLA, Job's Syndrome, DiGeorge Syndrome)
Secondary immunodeficiency due to treatment with a B-cell depleting therapy
Secondary hypogammaglobulinemia (IgG less than 5g/L) with a history of recurrent infections
Unable to take vaccination due to a documented allergy or anaphylactic reaction to the COVID-19 vaccination
Patient Requirements
Weigh at least 40 kg and be 12 years of age or older
No current COVID-19 infection
No known COVID-19 exposure within 8 days
More than 14 days since last COVID-19 vaccination and/or recovery from a COVID-19 infection
Ordering
Availability and administration is managed through processes external to Connect Care.
Resources
Patient assessment for eligibility: 1-844-343-0971
Prescriber information: call RAAPID (0800-2000)
