Preliminary Clinical Trial Findings: Remdesivir
Preliminary results of the Adaptive COVID -19 Treatment Trial (ACTT-1) trial suggest that a 10-day course of remdesivir was superior to placebo in the treatment of hospitalised patients with COVID-19 (subsequent data has shown that 5 days is equivalent to 10-days for patients who do not require mechanical ventilation). This benefit was seen in the number of days to recovery and in recovery. Even though the trial was ongoing, the data and safety monitoring board made the recommendation to unblind the results to the trial team members from the NIAID, who subsequently decided to make the results public. Given the strength of the results about remdesivir, these findings were deemed to be of immediate importance for the care of patients still participating in the trial as well as for those outside the trial who might benefit from treatment with remdesivir.
Interim Clinical Commissioning Policy: Remdesivir for patients hospitalised with COVID-19 (adults and children 12 years and older). Patients will be eligible for treatment with remdesivir in accordance with the product licence (www.ema.europa.eu). Eligibility criteria within the Remdesivir Summary of Product Characteristics (SmPC) include::
- Hospitalised with coronavirus disease 2019 (COVID-19)
- With pneumonia requiring supplemental oxygen
- Adults, and adolescents ≥ 12 years of age and ≥ 40 kg
- eGFR ≥ 30ml/min
- Alanine Aminotransferase (ALT) below 5 times the upper limit of normal at baseline
Benefit associated with Remdesivir has been demonstrated in trials which require a recently positive PCR result for enrolment.
Remdesivir is unlikely to improve clinical outcome in people who appear clinically to be in the recovery phase of illness.
Preliminary Clinical Trial Findings: Remdesivir
Preliminary results of the Adaptive COVID -19 Treatment Trial (ACTT-1) trial suggest that a 10-day course of remdesivir was superior to placebo in the treatment of hospitalised patients with COVID-19 (subsequent data has shown that 5 days is equivalent to 10-days for patients who do not require mechanical ventilation). This benefit was seen in the number of days to recovery and in recovery. Even though the trial was ongoing, the data and safety monitoring board made the recommendation to unblind the results to the trial team members from the NIAID, who subsequently decided to make the results public. Given the strength of the results about remdesivir, these findings were deemed to be of immediate importance for the care of patients still participating in the trial as well as for those outside the trial who might benefit from treatment with remdesivir.
Interim Clinical Commissioning Policy: Remdesivir for patients hospitalised with COVID-19 (adults and children 12 years and older). Patients will be eligible for treatment with remdesivir in accordance with the product licence (www.ema.europa.eu). Eligibility criteria within the Remdesivir Summary of Product Characteristics (SmPC) include::
- Hospitalised with coronavirus disease 2019 (COVID-19)
- With pneumonia requiring supplemental oxygen
- Adults, and adolescents ≥ 12 years of age and ≥ 40 kg
- eGFR ≥ 30ml/min
- Alanine Aminotransferase (ALT) below 5 times the upper limit of normal at baseline
Benefit associated with Remdesivir has been demonstrated in trials which require a recently positive PCR result for enrolment.
Remdesivir is unlikely to improve clinical outcome in people who appear clinically to be in the recovery phase of illness.
Resources
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Remdesivir for the Treatment of Covid-19 — Preliminary Report
The preliminary results of the first stage of the Adaptive Covid-19 Treatment Trial (ACTT-1), in which we evaluated treatment with remdesivir as compared with placebo.
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Interim Clinical Commissioning Policy: Remdesivir for patients hospitalised with COVID-19 (V2)
In response to the public health emergency posed by coronavirus disease 2019 (COVID-19), NHS England, working with the Devolved Administrations (DAs), has established a rapid policy development process to aid clinicians in offering best care and advice to patients with or at risk of COVID-19 across the UK. This document sets out the interim clinical commissioning position for the use of remdesivir for patients with COVID-19.
