3- Wednesday Research News – 10th November

1 – Inhaled budesonide for COVID-19 in people at higher risk of adverse outcomes in the community: interim analyses from the PRINCIPLE trial

• Inhaled budesonide has shown efficacy for treating COVID-19 in the community but has not yet been tested in effectiveness trials.
• They performed a multicenter, open-label, multi-arm, adaptive platform randomized controlled trial involving people aged ≥65 years, or ≥50 years with comorbidities, and unwell ≤14 days with suspected COVID-19 in the community (PRINCIPLE).
• Participants were randomized to usual care, usual care plus inhaled budesonide (800µg twice daily for 14 days), or usual care plus other interventions.
• In this updated interim analysis, inhaled budesonide reduced time to recovery by a median of 3 days in people with COVID-19 with risk factors for adverse outcomes. Once 28 day follow up is complete for all participants randomized to budesonide, final analyses of time to recovery and hospitalization/death will be published.

Source: MedRxiv

2- Symptoms and risk factors for hospitalization of COVID-19 presented in primary care

• This study they aimed to extend knowledge of early symptoms as a precondition of early identification, and to gain understanding of associations between early symptoms and the development of a severe course of the disease.
• Data collection comprised basic demographic data, risk factors and the recording of symptoms at several points in time in the course of the illness.
• Underrating unspecific symptoms as possible indicators for SARS-CoV-2 infection harbours the danger of overlooking early disease.
• Monitoring patients during their illness using the indicators for severe disease we identified may help to identify patients who are likely to profit from early intervention.

Source: MedRxiv

3- Impact of the COVID-19 pandemic on routine immunization coverage in children under 2 years old in Ontario, Canada: A retrospective cohort study

• The COVID-19 pandemic has caused a disruption in childhood immunization coverage around the world.
• This study aimed to determine the change in immunization coverage for children under 2 years old in Ontario, Canada, comparing time periods pre-pandemic to during the pandemic.
• Childhood immunization coverage rates for children under 2 years in Ontario decreased significantly during the early period of the COVID-19 pandemic and only partially recovered during the rest of 2020.
• Public health and educational interventions for providers and parents are needed to ensure adequate catch-up of delayed/missed immunizations to prevent potential outbreaks of vaccine-preventable diseases.

Source: MedRxiv

4- Dampening of the respiratory cytokine storm is promoted by inhaled budesonide in patients with early COVID-19

• Vaccinations against SARS-CoV-2 are effective in COVID-19.
• However, with limited vaccine access, vaccine hesitancy and variant breakthroughs, there is still a need for effective and safe early treatments.
• Two community-based clinical trials of the inhaled corticosteroid, budesonide, have recently been published showing and improvement in patients with COVID-19 treated early with budesonide
• To understand mechanistically how budesonide was beneficial, inflammatory mediators were assessed in the nasal mucosa of patients recruited to the Steroids in COVID (STOIC1) trial and a cohort of SARS-CoV-2 negative individuals.
• Here they show that in early COVID-19, elevation in viral response proteins and Th1 and Th2 inflammation occurs.
• Budesonide treatment decreased IL-33 and IFN-γ, implying a reduction in epithelial damage and dampening of the interferon response.
• Budesonide treatment also increased CCL17 concentrations, suggesting an improved T-cell response; and significantly alters inflammatory pathways giving further insight into how this treatment can accelerate patient recovery.

Source: MedRxiv

5- A Randomized Placebo-Controlled Trial of Sarilumab in Hospitalized Patients with Covid-19

• Sarilumab (anti-interleukin-6 receptor-α monoclonal antibody) may attenuate the inflammatory response in Covid-19.
• They performed an adaptive, phase 2/3, randomized, double-blind, placebo-controlled trial of intravenous sarilumab 200 mg or 400 mg in adults hospitalized with Covid-19.
• In hospitalized patients with Covid-19 receiving MV, numerical benefits with sarilumab did not achieve statistical significance, but benefit may be greater in patients receiving corticosteroids. A larger study is required to confirm this observed numerical benefit.

Source: MedRxiv

6- Time of day of vaccination affects SARS-CoV-2 antibody responses in an observational study of healthcare workers

• The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a global crisis with unprecedented challenges for public health.
• Vaccinations against SARS-CoV-2 have slowed the incidence of new infections and reduced disease severity.
• As the time-of-day of vaccination has been reported to influence host immune responses to multiple pathogens, they quantified the influence of SARS-CoV-2 vaccination time, vaccine type, age, sex, and days post-vaccination on anti-Spike antibody responses in healthcare workers.
• The magnitude of the anti-Spike antibody response associated with the time-of-day of vaccination, vaccine type, participant age, sex, and days post vaccination.
• These results may be relevant for optimizing SARS-CoV-2 vaccine efficacy.

Source: MedRxiv

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