Name (Synonyms) | Correlation | |
---|---|---|
drug891 | Vazegepant (BHV-3500) Wiki | 0.71 |
drug616 | Placebo Wiki | 0.07 |
Name (Synonyms) | Correlation | |
---|---|---|
D007239 | Infection NIH | 0.06 |
D018352 | Coronavirus Infections NIH | 0.04 |
Name (Synonyms) | Correlation |
---|
There are 2 clinical trials
Covid-19 has spread rapidly throughout the world causing widespread panic, death, and injury. While this virus is the provocateur, it is often the patient's own disproportionate immune response which deals the most devastating (and often fatal) damage. A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses. In the SOLID-C19 study, Soliris (Eculizumab) will be used to modulate the activity of the distal complement preventing the formation of the membrane attack complex. By modulating this portion of the immune response, mortality can be halted while the patient has time to recover from the virus with supportive medical care.
The overall objective of the study is to determine the therapeutic effect and tolerance of Eculizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Eculizumab is a terminal complement inhibitor that has been investigated for more than 10 years in numerous complement-mediated diseases. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Eculizumab administration to patients enrolled in the CORIMUNO-19 cohort. Eculizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Eculizumab will receive standard of care. Outcomes of Eculizumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.
Description: Survival without needs of intubation, events considered are intubation or death
Measure: Survival without needs of intubation at day 14 Time: 14 daysDescription: Change in organ failure at day 3, defined by the relative variation in Sequential Organ Failure Assessment score
Measure: Change in organ failure at day 3 Time: 3 daysDescription: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: Intubation free survival at day 14 Time: Day 14Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale at days 4, 7 and 14 Time: 4, 7 and 14 daysDescription: Overall survival
Measure: Survival at 14, 28 and 90 days Time: 14, 28 and 90 daysDescription: Time between inclusion and hospital discharge
Measure: Time to discharge Time: 90 daysDescription: Time between inclusion and oxygen supply independency
Measure: Time to oxygen supply independency Time: 90 daysDescription: Time between inclusion and negative viral excretion
Measure: Time to negative viral excretion Time: 90 daysDescription: Incidence of secondary infections (acquired pneumonia)
Measure: Incidence of secondary infections Time: 90 daysDescription: Vasopressor-free survival
Measure: Vasopressor-free survival Time: 90 daysDescription: Ventilator-free survival
Measure: Ventilator-free survival Time: 90 daysDescription: Number of ventilator-free days alive up to day 28
Measure: 28-day ventilator-free days Time: 28 daysDescription: Incidence of dialysis (renal replacement therapy)
Measure: Incidence of dialysis Time: 90 daysDescription: PaO2/FiO2 ratio
Measure: PaO2/FiO2 ratio Time: days 4, 7, 14Description: Number of patients with arterial blood pH of <7.25, with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours
Measure: Rate of respiratory acidosis at day 4 Time: 4 daysDescription: Time to ICU discharge
Measure: Time to ICU discharge Time: 90 days