• SARS-CoV-2 (COVID-19) infection confirmed by PCR or suspected using clinical and/or radiological information

AND

• Hospitalised specifically for the acute management of symptoms of SARS-CoV-2 (COVID-19)

AND

• Requiring low-flow supplemental oxygen

AND

• Presented to hospital not more than 10 days since symptom onset (does not apply to significantly immunocompromised patients – see later section)

AND

• Estimated glomerular filtration rate (eGFR) at least 30 ml/minute (haemodialysis patients exempt)

AND

Alanine aminotransferase (ALT) below 5 times the upper limit of normal at baseline

• Children aged less than 12 years
• Adolescents (aged 12 to 17 years) weighing less than 40kg
• Known hypersensitivity reaction to remdesivir or excipients as detailed in SPC
• eGFR less than 30ml/min (except haemodialysis patients)
• Alanine transaminase (ALT) at or above 5 times the upper limit of normal

Risk assessment

A risk score can aid clinical judgement on treatment with remdesivir. Patients with a low 4C Mortality Score (0-3) are highly likely to recover without remdesivir treatment.

If clinical judgement determines the patient is unlikely to survive on presentation to hospital, do not initiate remdesivir.  The 4C Mortality Score may be helpful in such cases. (See appendix 2 and calculation in the common admission document on the MORSE system)

Initiation of treatment

The decision to initiate treatment with remdesivir should be made by the admitting consultant

Review and stopping criteria

• Consider stopping if there is clinical improvement and supplemental oxygen is no longer required 72 hours after starting treatment.
• Consider stopping if the patient deteriorates despite 48 hours of sustained mechanical ventilation.
• Stop if ALT rises to 5 times the upper limit of normal or more during therapy with remdesivir (can restart if ALT falls below this threshold).
• Stop if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatise or INR
• Stop if eGFR falls below 30ml/min (except in end stage renal disease on haemodialysis)

Immunocompromised patients

The time between symptom onset and treatment starting does not apply

The need for supplemental oxygen does not apply

Definition of patient group: patients with a significant impairment of humoral immune response (antibody production) and/or cellular immune competence. 

Pregnancy

Remdesivir should be avoided in pregnancy unless clinicians believe the benefits of treatment outweigh the risks to the individual.  There are no or limited data from the use of remdesivir in pregnant women.  Women of child-bearing potential have to use effective contraception during treatment.

No formal consent is required to receive remdesivir via the conditional marketing authorisation. However, the prescriber should be aware of the conditional licensed status of Remdesivir.  Patients must be informed that remdesivir is not a fully licensed medicine and give informed consent prior to commencing treatment. 

Patients should be provided with a copy of the patient information leaflet (hard copy in the drug packaging).

The full prescribing information is provided in the summary of product characteristics .  Reported adverse effects include transaminase elevations, infusion related reactions (hypotension, nausea, vomiting, diaphoresis) and drug hypersensitivity – see SPC for more information. 

Remdesivir can be prescribed for patients meeting the criteria by the admitting consultant.  Stock will be held in Raigmore Hospital and Lorn and Islands Hospital. 

Remdesivir: 200mg as a single loading dose on day 1 followed by 100mg once daily for four days.  The treatment course is for a maximum of 5 days.

Significantly immunocompromised patients can receive up to 10 days per course.

Patients readmitted with COVID-19 who meet the eligibility criteria (except on timing from symptom onset) can received a second course of up to 5 days.

Administration

Remdesivir is administered intravenously by infusion once each day.

Remdesivir Powder – reconstitute 100mg vial with 19mls of water for injection then add to 100mls or 250mls of sodium chloride 0.9% and infuse over 30 to 120 minutes.  Using the longer, slower administration time can be considered to potentially prevent signs and symptoms of infusion-related reactions such as hypotension, nausea, vomiting and diaphoresis (sweating).

There is no interaction expected between remdesivir and other treatments for COVID-19.  Interactions with concomitant medications should be checked using the University of Liverpool COVID-19 Drug Interaction checker accessed via https://www.covid19-druginteractions.org/   As not all drugs are included on this website, please seek advice from the ward pharmacist, Medicines Information (ext 4288) or the on-call pharmacist.

Any suspected adverse drug reactions (ADRs) for patients receiving remdesivir should be reported directly to the MHRA via the dedicated COVID-19 Yellow Card reporting site at https://coronavirus-yellowcard.mhra.gov.uk/

Hospitals managing COVID-19 patients are encouraged to submit data through the ISARIC 4C Clinical Characterisation Protocol (CCP) case report forms, as co-ordinated by the COVID-19 Clinical Information Network (CO-CIN) (https://isaric4c.net/protocols/)

Please note: this interim advice will be reviewed following submission and assessment by Scottish Medicines Consortium in due course.

Interim Clinical Commissioning Policy: Remdesivir for patients hospitalized due to COVID-10 (adults and adolescents 12 years and older) Version 4 published 24 February 2022.  Available from https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103197

Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020;383(19):1813-1826. doi:10.1056/NEJMoa2007764

WHO Solidarity Trial Consortium, Pan H, Peto R, et al. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results. N Engl J Med. 2021;384(6):497-511. doi:10.1056/NEJMoa2023184

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From: Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score.

Published 9 Sep 2020 BMJ2020;370:m3339 http://dx.doi.org/10.1136/bmj.m3339

See also common admissions document on MORSE

4C Mortality Score