Health Canada signs regulatory approval for S-1226 COVID Phase II clinical trial
On the eve of 2021 SolAeroMed received regulatory notification from Health Canada that our proposed clinical trial of S-1226 in COVID patients received official approval.
This is approval was a long time coming and SolAeroMed management had been in discussions with Health Canada for 6 months working to address issues around the design of the S-1226 delivery device and design of the clinical trial itself. The trial seeks to show S-1226 will be a useful addition to treat COVID patients with S-1226 in addition to Standard of Care.
Summary features of the trial include:
- Recruit n=30 COVID patients (18-80 yr old) in local Alberta hospitals
- Randomize recruited patients into S-1226 + Standard of Care or Standard of Care alone
- In addition to standard of care, the S-1226 treatment group each receive treatment with inhaled S-1226 twice a day over 5 days.
- Outcome measures include changes in blood oxygenation (SpO2), vital signs, lung function parameters, COVID disease progress using the WHO ordinal scoring system, amongst others.
This open label (ie not blinded) Phase II trial is expected to progress in Q1 2021 results will be monitored on an ongoing basis. The trial is expected to provide First in Man Proof of Concept that inhaled S-1226 is safe for COVID patients, has evidence of efficacy in treating COVID disease, and will inform the design of a pivotal Phase III clinical trial.