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TD-0903 10mg (n=6) vs. placebo (n=6)
randomized controlled trial
TD-0903 10mg
Once-daily inhalation of TD-0903 10 mg (no loading dose) for up to 7 days.
Placebo
Matched placebo via inhalation for up to 7 days.
Phase IIa 4 arms: 3 different doses of TD-0903 (1mg, 3mg, 10mg) and placebo.
COVID-19 severe or critically
Patients 18 to 80 years of age with PCR confirmed, symptomatic COVID-19 (symptoms for 3–14 days) who were hospitalized and required supplemental oxygen to maintain saturation >90%.
Double-blind.
Multicenter: UK, Moldova, Ukraine.
Key safety outcomes were change from baseline in vital signs and clinical laboratory results, and incidence and severity of treatment-emergent AEs; key pharmacokinetic (PK) endpoints were plasma PK parameters on Days 1 and 7, and the key pharmacodynamic outcome was change from baseline SaO2/FiO2 ratio. Other clinical outcomes were considered exploratory.
Phase IIa (ascending-dose study).
TD-0903 1mg (n=6) vs. placebo (n=6)
randomized controlled trial
TD-0903 1mg
Once-daily inhalation of TD-0903 1 mg (Day 1 loading dose 2mg) for up to 7 days
Placebo
Matched placebo via inhalation for up to 7 days.
Phase IIa 4 arms: 3 different doses of TD-0903 (1mg, 3mg, 10mg) and placebo.
COVID-19 severe or critically
Patients 18 to 80 years of age with PCR confirmed, symptomatic COVID-19 (symptoms for 3–14 days) who were hospitalized and required supplemental oxygen to maintain saturation >90%.
Double-blind.
Multicenter: UK, Moldova, Ukraine.
Key safety outcomes were change frombaseline in vital signs and clinical laboratory results, and incidence and severity of treatment-emergent AEs; key pharmacokinetic (PK) endpoints were plasma PK parameters on Days 1 and 7, and the key pharmacodynamic outcome was change from baseline SaO2/FiO2 ratio. Other clinical outcomes were considered exploratory.
Phase IIa (ascending-dose study).
TD-0903 3mg (n=7) vs. placebo (n=6)
randomized controlled trial
TD-0903 3mg
Once-daily inhalation of TD-0903 3mg (Day 1 loading dose 6mg) for up to 7 days.
Placebo
Matched placebo via inhalation for up to 7 days.
Phase IIa 4 arms: 3 different doses of TD-0903 (1mg, 3mg, 10mg) and placebo.
COVID-19 severe or critically
Patients 18 to 80 years of age with PCR confirmed, symptomatic COVID-19 (symptoms for 3–14 days) who were hospitalized and required supplemental oxygen to maintain saturation >90%.
Double-blind.
Multicenter: UK, Moldova, Ukraine.
Key safety outcomes were change from baseline in vital signs and clinical laboratory results, and incidence and severity of treatment-emergent AEs; key pharmacokinetic (PK) endpoints were plasma PK parameters on Days 1 and 7, and the key pharmacodynamic outcome was change from baseline SaO2/FiO2 ratio. Other clinical outcomes were considered exploratory.
Phase IIa (ascending-dose study).
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