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Press Releases

Take a look at a selection of our recent media coverage:

Remdesivir use in COVID-19 patients requiring ventilator support confers no advantage over standard care

12th April 2022

A study found that remdesivir use among COVID-19 patients in need of ventilator support offers no advantage over standard care

Remdesivir use among patients hospitalised with COVID-19 requiring ventilator or oxygen support did not improve clinical outcomes after 15 days compared with standard care. This was the conclusion of a European, multi-centre, open label, randomised, controlled trial.

Remdesivir is a pro-drug that is converted into a nucleoside analog and incorporated by the RNA-dependent RNA polymerase of COVID-19 into the growing RNA product before RNA synthesis stalls. The drug was approved by the EMA in June 2020 for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Moreover, early data on remdesivir was encouraging and in a study of over 1000 patients, those randomised to remdesivir use had a median recovery time of 10 days compared with 15 days in those who received placebo. In contrast, however, the World Health Organization (WHO) Solidarity Trial, concluded that remdesivir, along with hydroxychloroquine, lopinavir and interferon regimens, had little or no effect on hospitalised patients with COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay. 

With such conflicting results, the European team undertook the DisCoVeRy trial and which was designed to evaluate the safety and efficacy of possible therapeutic agents in hospitalised adult patients diagnosed with COVID-19. Recruited patients were adults hospitalised with COVID-19 who presented with either evidence of rales/crackles on examination and a SpO2 < 94% on room air or had a requirement for supplemental oxygen, high flow oxygen devices, non-invasive ventilation and/or mechanical ventilation. Patients were randomised 1:1 to either remdesivir use (200 mg on day 1 followed by a 100 mg 1-hour infusion once daily for 10 days) or standard care, which included the use of corticosteroids and anticoagulants. The primary outcome was the patient’s clinical status at day 15 as recorded on the 7-point ordinal WHO scale. The scale, which represents increasingly severe disease, ranges from 1 represented those not hospitalised and with no limitation on activities, through 5 (hospitalised on non-invasive ventilation or high flow oxygen) and 6 (hospitalised on invasive mechanical ventilation or extracorporeal membrane oxygenation) and 7 (dead). Several secondary outcomes were also used including in-hospital mortality and 28-day mortality.

Remdesivir use and clinical outcomes

A total of 857 participants with a median age of 64 years (69.5% male) were randomised to remdesivir (420) or standard care and, at randomisation, 39.4% of individuals had severe COVID-19.

Overall, 73.6% of participants had at least one co-morbidity with the most frequent being obesity (34.1%), cardiac disease (28%) and diabetes (27%).

At day 15, a similar proportion of those assigned to remdesivir and standard care were categorised as 1 on the WHO scale (14.8% vs 17%, remdesivir vs standard care) and a similar proportion had died (5% vs 6%). Overall, there was no significant difference between those assigned to remdesivir use or standard care (odds ratio, OR = 1.02, 95% CI 0.62 – 1.70, p = 0.93). Additionally, there were no significant differences in the distribution of the 7-point scale at day 29 (OR = 1.11, 95% CI 0.87 – 1.43, p = 0.40).

Furthermore, there were no significant differences for each of the secondary outcomes or subgroup analyses according to age, sex, duration of symptoms prior to randomisation or in the level of detectable viral loads at each sampling time.

The authors therefore concluded that the remdesivir use had no impact on clinical outcomes compared with standard care at either day 15 or day 29.

Citation
Ader F et al. Remdesivir for the treatment of hospitalised patients with COVID-19: final results from the DisCoVeRy randomised, controlled, open-label trial MedRxiv 2022

FDA approves baricitinib remdesivir combination for COVID-19

30th November 2020

Adding baricitinib to remdesivir improves recovery time in patients with COVID-19.

On 19 November, 2020, the FDA gave emergency use authorisation for the baricitinib combination therapy to be used in patients hospitalised with either confirmed or suspected COVID-19, from 2 years of age and who require mechanical ventilation, supplemental oxygen or extracorporeal membrane oxygenation.

The approval is based on preliminary results from the ACCT-2 trial, which compared the recovery time in patients receiving either remdesivir alone or in combination with the JAK STAT inhibitor, baricitinib at a dose of 4mg. Remdesivir is already approved by the FDA as an antiviral drug for hospitalised COVID-19 patients, aged 12 years and over. Baricitinib is currently only licensed for use in rheumatoid arthritis but since the drug blocks the JAK-STAT intracellular messaging system, which is an important inflammatory pathway, there was a potential benefit from combining the two drugs. ACCT-2 was a Phase III trial that enrolled 1033 participants, who were randomised to either intravenous remdesivir alone plus matching placebo (518) or oral baricitinib (515). Remdesivir was given as a loading dose of 200mg, followed by 100 mg daily while in hospital, for up to 10 days. Baricitinib was given at a dose of 4mg per day and limited to a maximum of 14 days. All patients were assessed daily and if discharged, they were followed-up at home on days 15, 22 and at the study endpoint, day 29. Recovery from COVID-19 was defined as either being discharged from hospital, no longer requiring supplemental oxygen or needing ongoing medical care.

Preliminary data published from the trial showed that the median time to recovery with remdesivir and baricitinib was one day shorter (7 vs 8 days) than using remdesivir alone and this difference was statistically significant. In addition, the odds of a clinical improvement at day 15 using the combined therapy was also found to be significantly lower. Under the emergency use authorisation, the manufacturer of baricitinib, Eli Lilly, is required to provide both health professionals and patients, fact sheets which include information on dosing, side-effects and drug interactions. The full results of the ACCT-2 trial will be published in due course.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19

FDA approves remdesivir for COVID-19

30th October 2020

The US Food and Drug Administration (FDA) approved remdesivir (brand name Veklury) on 22 October 2020 for use in adults and paediatric patients aged 12 years and over and weighing at least 40kg for the treatment of COVID-19 in patients requiring hospitalisation.

The approval requires that remdesivir is only used in a hospital or healthcare setting capable or providing acute care which is comparable to hospital care. This new approval does not however, include the entire population that was originally included via the emergency use authorisation (EUA) issued on 1 May 2020. In order to allow continued use in paediatric patients the EUA was amended for use only in laboratory confirmed COVID-19 cases for patients weighing 3.5 to less than 40kg less or hospitalised children under 12 years of age weighing at least 3.5kg. However, the FDA makes clear that this is NOT an approved use of the drug and that this authorisation is only temporary and could be revoked.

The approval in adults was based on three randomised clinical trials which showed that treatment with remdesivir lead to clinically meaningful improvements across multiple outcomes compared to placebo. For instance, in the most recent ACTT-1 trial, published in the New England Journal of Medicine, remdesivir significantly improved time to recovery by 5 days and reduced disease progression among patients requiring oxygen. It also showed an improved time to recovery among patients not requiring oxygen in the SIMPLE-Moderate trial conducted in hospitalised patients. Moreover, adverse effects with remdesivir were similar to placebo.
Remdesivir was approved under the early access to medicines scheme in the UK in May 2020.

Reference
FDA News release. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19