Name (Synonyms) | Correlation | |
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drug273 | Assigned Strategies: Enhanced Active Choice Wiki | 1.00 |
drug272 | Assigned Strategies: Active Choice Wiki | 1.00 |
drug665 | Choice of Assignment: Enhanced Active Choice Wiki | 1.00 |
drug84 | AMY-101 Wiki | 1.00 |
drug664 | Choice of Assignment: Active Choice Wiki | 1.00 |
drug666 | Choice of Assignment: Opt-in Wiki | 1.00 |
drug274 | Assigned Strategies: Opt-in Wiki | 1.00 |
Name (Synonyms) | Correlation | |
---|---|---|
D013577 | Syndrome NIH | 0.10 |
D055371 | Acute Lung Injury NIH | 0.10 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.09 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.08 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of AMY-101, a potent C3 inhibitor, for the management of patients with ARDS caused by SARS-CoV-2 infection. We will assess the efficacy and safety, as well as pharmacokinetics (PK), and pharmacodynamics (PD). The study will assess the impact of AMY-101 in patients with severe COVID19; specifically, it will assess the impact of AMY-101 1) on survival without ARDS and without oxygen requirement at day 21 and 2) on the clinical status of the patients at day 21.
Description: The clinical status is based on the following six-category ordinal scale: 1: not hospitalised; 2: hospitalised, not requiring supplemental oxygen; 3: hospitalised, requiring supplemental oxygen; 4: hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; 5: hospitalised, requiring ECMO, invasive mechanical ventilation, or both; and 6: death.
Measure: The proportion of patients assigned to each category, of a six-category ordinal scale. Time: 21 daysDescription: The clinical status is based on the following six-category ordinal scale: 1: not hospitalised; 2: hospitalised, not requiring supplemental oxygen; 3: hospitalised, requiring supplemental oxygen; 4: hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; 5: hospitalised, requiring ECMO, invasive mechanical ventilation, or both; and 6: death.
Measure: The proportion of patients assigned to each category, of a six-category ordinal scale. Time: On days 7, 14, and 44Description: With respiratory failure defined as any of the following: Worsening of severe gas transfer deficit, accounting for a shift in ARDS disease category (PaO2/FiO2 ≤200 for patients with PaO2/FiO2 >200 at baseline; PaO2/FiO2 ≤100 for patients with PaO2/FiO2 >100 at baseline), Persistent respiratory distress while receiving oxygen (persistent marked dyspnea,use of accessory respiratory muscles, paradoxical respiratory movements), Transfer to the intensive care unit for intubation, Death.
Measure: Proportion of respiratory failure-free survival Time: Day 44