Two newsworthy news in the fight against Covid-19 from the UK yesterday.
First, there was a small double blind placebo-controlled RCT using a novel inhaled formulation of interferon beta SNG001 in hospitalised COVID-19 patients.
The trial recruited 101 patients from 9 specialist hospital sites in the UK. Patient groups were evenly matched in terms of average age, comorbidities and average duration of COVID-19 symptoms.
The odds of developing severe disease (e.g. requiring ventilation or resulting in death) during the treatment period (day 1 to 16) were significantly reduced by 79% for patients receiving SNG001 compared to patients who received placebo (OR 0.21 [95% CI 0.04-0.97]; p=0.046).
Patients who received SNG001 were more than twice as likely to recover (defined as ‘no limitation of activities’ or ‘no clinical or virological evidence of infection’) compared to those receiving placebo (HR 2.19 [95% CI 1.03-4.69]; p=0.043).
Three subjects (6%) died after being randomised to placebo. There were no deaths among subjects treated with SNG001.
The targeted approach of this drug is very attractive. These positive results are more emphatic than anything we’ve seen with other drugs. Certainly more than remdesivir! Note the p values are just significant! Let us see if further trials confirm the efficacy of beta interferon. Statement and presentation pdf from Synairgen.
Virus Vector Vaccine
The race to a COVID-19 vaccine has over over 130 contenders and is heating up with the first positive phase 2 results coming out.
Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Folegatti, Pedro MAboagye, Jeremy et al.The Lancet, Volume 0, Issue 0
The Oxford COVID Vaccine Trial Group assessed the safety, reactogenicity, and immunogenicity of a viral vectored coronavirus vaccine that expresses the spike protein of SARS-CoV-2 in a phase 1/2, single-blind RCT in the UK of a chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCoV-19) expressing the SARS-CoV-2 spike protein compared with a meningococcal conjugate vaccine (MenACWY) as control. Healthy adults aged 18–55 years with no laboratory confirmed COVID-19 infection or of COVID-19-like symptoms were randomly assigned (1:1) to receive ChAdOx1 nCoV-19 or MenACWY as a single intramuscular injection.
1077 participants were enrolled and assigned to receive either ChAdOx1 nCoV-19 (n=543) or MenACWY (n=534). Local and systemic reactions were more common in the ChAdOx1 nCoV-19 group anf included pain, feeling feverish, chills, muscle ache, headache, and malaise (all p<0·05). No serious adverse events were related to ChAdOx1 nCoV-19. In the ChAdOx1 nCoV-19 group, spike-specific T-cell responses peaked on day 14. Anti-spike IgG responses rose by day 28 and were boosted following a second dose. Neutralising antibody responses against SARS-CoV-2 were detected in 91% of 35 participants after a single dose. After a booster dose, all participants had neutralising activity.
ChAdOx1 nCoV-19 showed an acceptable safety profile, and homologous boosting increased antibody responses. These results, together with the induction of both humoral and cellular immune responses, support large-scale evaluation of this candidate vaccine in an ongoing phase 3 programme.