Name (Synonyms) | Correlation | |
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drug1733 | Mesenchymal cells Wiki | 1.00 |
drug2707 | Standard of care Wiki | 0.23 |
drug2122 | Placebo Wiki | 0.05 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase III trial to compare two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe COVID 19. Arm A: CD24Fc/Best Available Treatment; Arm B: placebo/ Best Available Treatment. CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 230 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. All subjects will be treated with the best available treatment. The follow up period is 28 days.
Description: Time to improve in clinical status: the time (days) required from the start of treatment to the improvement of clinical status "severe" to "moderate/mild"; or improvement from "scale 3 or 4" to "scale 5 or higher" based on NIAID ordinal scales.
Measure: Improvement of COVID-19 disease status Time: 29 daysDescription: Proportion of patients who died or had respiratory failure, defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high flow oxygen devices, at Day 29
Measure: Proportion of patients who died or had respiratory failure. Time: 29 daysDescription: Time for disease progression from NIAID scale 3 or 4 to need to be on invasive mechanical ventilation, or ESMO, or death.
Measure: Disease progression of COVID-19 Time: 29 daysDescription: All cause of death
Measure: All cause of death Time: 29 daysDescription: Proportion of clinical relapse, as defined by rate of return to oxygen support for more than 1 day within 29 days from randomization after initial recovery
Measure: Proportion of clinical relapse Time: 29 daysDescription: Conversion rate of clinical status on days 8 (proportion of subjects who changed from NIAID ordinal "scale 3 or 4" to "scale 5 or higher")
Measure: Conversion rate of clinical status at Day 8 Time: 8 daysDescription: Conversion rate of clinical status on days 15 (proportion of subjects who changed from NIAID ordinal "scale 3 or 4" to "scale 5 or higher")
Measure: Conversion rate of clinical status at Day 15 Time: 15 daysDescription: The discharge time, calculated after the randomization.
Measure: Hospital discharge time Time: 29 daysDescription: Duration of mechanical ventilation (IMV, NIV) (days)
Measure: Duration of mechanical ventilation Time: 29 daysDescription: Duration of pressors (days)
Measure: Duration of pressors Time: 29 daysDescription: Duration of extracorporeal membrane oxygenation (days)
Measure: Duration of ECMO Time: 29 daysDescription: Duration of oxygen therapy (oxygen inhalation by high flow nasal cannula or mask) (days)
Measure: Duration of high flow oxygen therapy Time: 29 daysDescription: Changes of absolute lymphocyte count in peripheral blood
Measure: Absolute lymphocyte count Time: 29 daysDescription: The changes of plasma concentration of D-dimers
Measure: Change of D-dimers Time: 15 and 29 days