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Press Releases

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

Paxlovid reduces hospitalisation and death in COVID-19

9th November 2021

Paxlovid, a novel COVID-19 oral anti-viral treatment, significantly reduced the risk of hospitalisation and death in patients with the virus.

Paxlovid given within three days of symptom onset to patients with COVID-19 significantly reduced the risk of hospitalisation and death. These were the results of an interim analysis posted by the manufacturer, Pfizer.

Paxlovid is a combination of Pfizer’s experimental drug (PF-00835231) and ritonavir. Both are protease inhibitors, a class of anti-viral drugs that have been used in the treatment of viral infections such as HIV and hepatitis C. COVID-19 produces a protease termed Mpro, which is vital to viral replication, and PF-00835231 been been found to be a potent inhibitor of Mpro. According to the manufacturer, co-administration of PF-00835231 and a low dose of ritonavir helps slow the metabolism of PF-07321332 so that it remains active for a longer period of time and at higher concentrations to help combat the virus.

Clinical study

In a clinical study, Paxlovid was used for the treatment of adults infected with COVID-19 but who, at the time of their illness, were not deemed sufficiently unwell to require hospitalisation but who were, however, considered to be at a higher risk of developing more severe illness. The study, Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR), is a randomised, 1:1, double-blind study, in which individuals received paxlovid or placebo orally every 12 hours for 5 days. The primary outcome of the study was the proportion of participants with COVID-19 related hospitalisation or death from any cause between days 1 and 28 after randomisation.

According to a pre-specified interim analysis based on 1219 participants, there was an 89% reduction in risk of COVID-19-related hospitalisation or death from any cause compared to placebo, in patients treated within three days of symptom onset. Overall, 3/389 (0.8%) who received paxlovid were hospitalised through to day 28 and there were no deaths but among 385 participants assigned to placebo, 27/395 (7.0%) were hospitalised and there were 7 deaths and this difference compared with Paxlovid was statistically significant (p < 0.0001).

Among patients treated within 5 days of symptom onset, 1.0% of those given Paxlovid were hospitalised through to day 28 (6/607) compared with 6.7% (41/612) of those given placebo (p < 0.0001). Moreover, to date, there have been no deaths were reported in patients receiving Paxlovid and 10 deaths in the placebo group.

According to the press release, based on a recommendation of the independent data monitoring committee and after consultation with the FDA, Pfizer will cease further enrolment and submit the data for the FDA’s emergency use authorisation (EUA) as soon as possible.

Further trials with Paxlovid are on-going and the company will release these results in due course.

Source. Pfizer press release, 5/11/2021

Fluvoxamine in high-risk COVID-19 patients reduces time spent at hospital

2nd November 2021

Fluvoxamine given to patients with risk factors for COVID-19 hospitalisation reduced their overall time spent in emergency care.

Giving fluvoxamine to patients with one or more risk factors for severe illness in COVID-19, reduced the proportion of patients requiring more than 6 hours of emergency care when administered within 7 days of symptom onset. This was the conclusion of a study from researchers based at the Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Brazil. Although vaccination against COVID-19 has become a priority across the globe, some work is continuing on the repurposing of existing medicines to treat the virus. One such drug is the antidepressant fluvoxamine which is an agonist for the sigma-1 receptor which is a chaperone protein at the endoplasmic reticulum with anti-inflammatory properties. In addition, a previous small trial in 152 patients with COVID-19, found that those given fluvoxamine had a lower likelihood of clinical deterioration over 15 days.

For the present study, researchers wanted to provide more robust evidence for the value of fluvoxamine in COVID-19. They performed a randomised, placebo-controlled trial among individuals who presented at an outpatient care setting with acute symptoms consistent with COVID-19 infection. All included patients had at least one additional risk factor for more severe illness e.g., diabetes, hypertension, symptomatic asthma etc., and a positive rapid antigen test for COVID-19. Individuals were then randomised 1:1 to receive fluvoxamine 100 mg twice daily for 10 days or matching placebo within 7 days of the onset of COVID-19 symptoms. The primary outcome was a composite endpoint of medical admission to a hospital setting due to COVID-19-related illness but who remained longer than 6 hours or who were hospitalisation due to progression of their illness within 28 days of randomisation. Several secondary outcomes were measured including hospitalisation for COVID-19, time to hospitalisation, number of days in hospital.

Findings

A total of 1497 patients with a mean age of 50 years (58% female) were randomised to either fluvoxamine or placebo. Overall, 180 patients assigned to fluvoxamine and 251 given placebo had any form of interaction with a COVID-19 emergency setting (relative risk, RR = 0.73, 95% CI 0.62 – 0.88). In the treatment group, 11% of participants compared with 16% in the placebo arm had the primary outcome event, of which 87% were hospitalisations, (RR = 0.69, 95% CI 0.53 – 0.90), giving a number needed to treat of 20 (i.e., 1/0.05).

There were no significant differences for any of the secondary outcomes, e.g., for hospitalisations ,the rates were 10% vs 13% (fluvoxamine vs placebo, p = 0.10). In addition, there 17 deaths in the treatment arm and 25 in the placebo group which was also non-significant.

The authors commented on how use of fluvoxamine for 10 days, was associated with a clinically important absolute risk reduction of the primary outcome. Furthermore, a limitation was the the study was undertaken before the more widespread availability of COVID-19 vaccines hence it remains unclear as to the effectiveness of fluvoxamine in those who have been vaccinated.

Citation

Reis G et al. Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial. Lancet Glob Health 2021