The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
Exclusion Criteria:
Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay
Non-invasive ventilation continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) or high-flow nasal oxygen therapy (WHO OSCI score of 5)
Endotracheal intubation and invasive mechanical ventilation (WHO OSCI score of =6) or admission to intensive care
Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay
Any condition, including findings in the patients' medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation
Participation in previous clinical trials of SNG001
Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study
Inability to use a nebuliser with a mouthpiece
Inability to comply with the requirements for storage conditions of study medication in the home setting
History of hypersensitivity to natural or recombinant IFN-ß or to any of the excipients in the drug preparation
Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
Inclusion Criteria:
Admitted to hospital due to the severity of their COVID-19
Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had a positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test is performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had their first positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection
Require oxygen therapy via nasal prongs or mask (WHO OSCI score of 4)
Provided informed consent
Female patients must be =1 year post-menopausal, surgically sterile, or using a protocol defined highly effective method of contraception
Women of child bearing potential should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled interferon-ß (IFN-ß1a)/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in United Kingdom with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-ß1a/matching placebo to prevent pregnancy
Women not of childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply: women <50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range; women =50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment. If, in the setting of the pandemic, the use of an acceptable birth control method is not possible, the decision to enrol a woman of childbearing potential should be based on the benefit-risk for the patient, which should be discussed with the patient at the time of the informed consent.
Yes, being vaccinated was not an exclusion criteria. You can see it here: https://clinicaltrials.gov/ct2/show/NCT04732949
Well that's a dangerous game to play! Not much to gain in the interim as the 50 day moving average seems to be holding well as a support line. They are just taking a big bet on a p3 fail.
Think that's now shown to be lab contamination: https://www.independent.co.uk/news/science/deltacron-variant-cases-cyprus-covid-b1989961.html
More on this:
"There is a possibility that Omicron is so transmissible that it has hit a ceiling whereby future variants will struggle to outcompete it. But just a few months ago, people were saying the same thing about Delta. Also, Omicron is likely to keep evolving. “What might play out is that as Omicron infects so many people, it’s harder for that first Omicron [variant] to continue to be as successful, and so that creates a space for a virus that’s better at evading the immune response,” Robertson said."
https://www.theguardian.com/world/2022/jan/11/will-covid-19-become-less-dangerous-as-it-evolves
No probs Morg.
A couple of interesting comments on the twitter thread which would seem to make sense, and highlight the need for treatments:
"Would that also imply that partial protection by infection during a previous wave is on average much worse than for influenza, since the "distance" is larger?"
"Yeah, that's what I get. Just as long as you've had Omicron you might fair well against it's children for a while, but suddenly it's cousin could reappear and take over and you wouldn't be so well protected."
So far prior infection (or vaccination) against a previous variant is still good (as basically it's the same virus). However, whilst offering partial protection it doesn't go the whole way so you can still catch it and get sick / pass it on and this could be worse with a new varient that is sufficiently different. All of which supports the stockpile argument for generic anti-virals like SNG001 in case a variant emerges that has a high level of immune escape.
https://t.co/MKe6QccGWw
Interesting to see that SARS-CoV-2 isn't evolving like other seasonal viruses yet, and that omicron didn't mutate from delta (and so on). So for those who say that the virus is evolving to get milder aren't quite telling the whole truth. Quite frankly it's a bit of luck which evolutionary path is chosen. All we do know is that omicron is dominant as it's more contagious, but it's luck that it is less severe and the next mutation could be the worst of both worlds contagious and severe outcomes.
Thanks for bumping this. A nice read whilst we wait. Tick followed tock followed tick followed tock followed tick https://youtu.be/Y9znA_dwjHw
Discussions relevant to therapeutics is fine, but we can do without anti-vax threads. Always brings the loonies out! And we need to keep sensible discussion publicly accessible rather than being closed to Reddit. After all this is how I found out about Synairgen