Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04402866 | TD-0903 for ALI Associated With COVID-19 | PHASE2 | COMPLETED | 235 | — | — | Jun 24, 2020 | Apr 21, 2021 | Mar 17, 2022 | 24 | United States, Brazil +5 |
| NCT04350736 | First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19 | PHASE1 | COMPLETED | 54 | — | — | Apr 23, 2020 | Jul 1, 2020 | Jul 1, 2021 | 1 | United Kingdom |
An RFD was defined as a day that a participant was alive and did not require the use of any respiratory support (invasive mechanical ventilation, non-invasive positive pressure ventilation, high-flow oxygen devices, or oxygen supplementation) from randomization through Day 28. The number of RFDs was 0 for participants who used respiratory support for 28 days or longer or for participants who died on or before Day 28. A clinical status score of ≤ 4 on a given day was equivalent to an RFD. The clinical status categories and associated scores ranged from 1-8 where a higher score represented a worse outcome. A clinical status score of 4 was defined as a participant who was hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (whether or not related to COVID-19).
Number and severity of treatment emergent adverse events
Number and severity of treatment emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Part 1: TD-0903 - MAD Dose A | EXPERIMENTAL | 6 out of 8 subjects per cohort will be randomized to receive TD-0903 MAD Dose A |
| Part 1: TD-0903 - MAD Dose B | EXPERIMENTAL | 6 out of 8 subjects per cohort will be randomized to receive TD-0903 MAD Dose B |
| Part 1: TD-0903 - MAD Dose C | EXPERIMENTAL | 6 out of 8 subjects per cohort will be randomized to receive TD-0903 MAD Dose C |
| Part 1: Placebo for MAD | EXPERIMENTAL | 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo |
| Part 2: TD-0903 | EXPERIMENTAL | 99 subjects will be randomized to receive TD-0903 |
| Part 2: Placebo | EXPERIMENTAL | 99 subjects will be randomized to receive Placebo |
| TD-0903 for SAD (Part A) | EXPERIMENTAL | 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903 |
| Placebo for SAD (Part A) | EXPERIMENTAL | 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo |
| TD-0903 for MAD (Part B) | EXPERIMENTAL | 8 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903 |
| Placebo for MAD (Part B) | EXPERIMENTAL | 2 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo |
| Name | Type | Description |
|---|---|---|
| TD-0903 | DRUG | Study Drug to be administered by inhalation |
| Placebo | DRUG | Placebo to be administered by inhalation |
Inclusion Criteria: * Willing and able to provide written informed consent on their own prior to performing study procedures. In the U.K., subject assent or proxy consent as per local site procedures, may also be acceptable if both a clinician and second health professional attest that the subject ...