Name (Synonyms) | Correlation | |
---|---|---|
drug1887 | No intervention Wiki | 0.24 |
drug2122 | Placebo Wiki | 0.05 |
Name (Synonyms) | Correlation | |
---|---|---|
D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.04 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
Patients with documented moderate COVID-19 infection will be randomized 1:1 to receive piclidenoson 2 mg Q12H orally with standard supportive care (SSC - intervention arm) or placebo orally with SSC (control arm) for up to 28 days.
Description: Proportion of subjects alive and free of respiratory failure (defined as need for non-invasive or invasive mechanical ventilation, high-flow oxygen, or extracorporeal membrane oxygenation) at Day 29
Measure: Proportion of subjects alive and free of respiratory failure Time: 29 daysDescription: Proportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29
Measure: Proportion of subjects discharged home alive Time: 29 daysDescription: Proportion of patients experiencing AEs
Measure: Treatment-emergent adverse events (AEs) Time: 29 daysDescription: Clinical status at Day 29 on a 7-point ordinal scale, where 1 = not hospitalized with resumption of normal activities; 2 = not hospitalized but unable to resume normal activities; 3 = hospitalized but not requiring supplemental oxygen; 4 = hospitalized and requiring supplemental oxygen; 5 = hospitalized and requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6 = hospitalized and requiring invasive mechanical ventilation and/or extra-corporeal membrane oxygenation; and 7 = death
Measure: Clinical status Time: 29 daysDescription: Time (days) to improvement of 2 points on 7-point ordinal clinical scale
Measure: Time to improvement Time: 29 daysDescription: Proportion of patients who require mechanical ventilation
Measure: Incidence of mechanical ventilation Time: 29 daysDescription: Ventilator-free days to Day 29
Measure: Ventilator-free days Time: 29 daysDescription: Proportion of patients who require ICU admission
Measure: Incidence of Intensive Care Unit (ICU) admission Time: 29 daysDescription: Duration (days) of ICU stay
Measure: Duration of ICU stay Time: 29 daysDescription: Time (days) to hospital discharge
Measure: Time to hospital discharge Time: 29 daysDescription: Duration (days) of need for supplemental oxygen
Measure: Duration of need for supplemental oxygen Time: 29 daysDescription: Time (days) to virus negativity by RT-PCR, defined as absence of SARS CoV 2 on 2 consecutive days of sampling
Measure: Time to virus negativity Time: 29 daysDescription: SARS-CoV-2 viral load (number of copies) by quantitative RT-PCR
Measure: SARS-CoV-2 viral load Time: 29 daysDescription: Proportion of patients experiencing AEs leading to early discontinuation of trial treatment
Measure: AEs leading to withdrawal Time: 29 daysDescription: Proportion of patients experiencing SAEs
Measure: Treatment-emergent serious AEs (SAEs) Time: 29 daysDescription: Proportion of patients experiencing treatment-emergent changes in clinical laboratory parameters or ECGs
Measure: Treatment-emergent abnormalities in clinical laboratory parameters or electrocardiograms (ECGs) Time: 29 daysDescription: Proportion of patients who meet study safety-related stopping rules
Measure: Incidence of meeting safety-related stopping rules Time: 29 daysDescription: Plasma concentrations over time of piclidenoson
Measure: Pharmacokinetics of piclidenoson in this patient population Time: 5 days