Table 1 Overview of industry sponsored clinical trials of IL-6 signal inhibitors for COVID-19 pneumonia
From: Outlook of IL-6 signaling blockade for COVID-19 pneumonia
Drug | Trial name | Location | Design | Patient population and number | Primary endpoint |
|---|---|---|---|---|---|
Tocilizumab | COVACTA NCT04320615 [41] | Global | DB/PBO TCZ + SOC vs PBO + SOC | Hospitalized with COVID-19 pneumonia confirmed per a positive PCR of any specimen and evidenced by chest x-ray or CT scanand SpO2 ≤ 93% or PaO2/FiO2 < 300 mmHg 450 | Clinical status as per the 7-category ordinal scale at day 28 |
Tocilizumab | MARIPOSA NCT04363736 [42] | US | OL TCZ 4 mg/kg TCZ 8 mg/kg | Hospitalization with COVID-19 pneumonia confirmed by a positive PCR of any specimen and evidenced by chest x-ray or CT For severe patients, SpO2 ≤ 93% or PaO2/FiO2 < 300 mmHg For moderate patients, CRP > 2 × ULN 100 | PK/PD responses to tocilizumab |
Tocilizumab | REMDACTA NCT04409262 [43] | Global | DB/PBO TCZ + RDV vs PBO + RDV | Hospitalized with COVID-19 pneumonia confirmed per a positive PCR of any specimen and evidenced by chest x-ray or CT scan and SpO2 ≤ 93% or PaO2/FiO2 < 300 mmHg or requiring supplemental oxygen to maintain SpO2 > 93% 450 | Clinical status as per the 7-category ordinal scale at day 28 |
Tocilizumab | EMPACTA NCT04372186 [44] | US | DB/PBO TCZ + SOC vs PBO + SOC | Hospitalized with COVID-19 pneumonia confirmed per a positive PCR of any specimen and evidenced by chest X-ray or CT scan Requiring more than 6 L/min supplemental oxygen to maintain SpO2 > 93% 379379 | Cumulative proportion of participants requiring mechanical ventilation by day 28 |
Tocilizumab | JapicCTI-205270 [45] | Japan | OL | Hospitalized with COVID-19 pneumonia confirmed per a positive PCR of any specimen and evidenced by chest x-ray or CT scan and SpO2 ≤ 93% or PaO2/FiO2 < 300 mmHg 10+ | Clinical status as per the 7-category ordinal scale at Day 28 |
Sarilumab | NCT04315298 [46] | US | DB/PBO SARI dose1 + SOC vs SARI dose2 + SOC vs PBO + SOC dose3 + SOC vs PBO + SOC | P2: adult patients hospitalized with COVID-19 regardless of disease severity strata P3 cohort 1: adult patients hospitalized with critical COVID-19 on mechanical ventilation at baseline P3 cohort 2: adult patients hospitalized with COVID-19 receiving mechanical ventilation at baseline P3 cohort 3: adult patients hospitalized with COVID-19 receiving high-intensity oxygen therapy without mechanical ventilation at baseline. 2500 | Phase 2: Percent change in CRP levels by day 4 Phase 3: Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale up to day 22 |
Sarilumab | NCT04327388 [47] | Global | DB/PBO SARI dose1 + SOC vs SARI dose2 + SOC vs PBO + SOC | Hospitalized for less than or equal to 7 days with evidence of pneumonia and has one of the following disease categories: severe disease or critical disease laboratory-confirmed SARS-CoV-2 infection 400 | Time to improvement of 2 points in clinical status assessment from baseline using the 7-point ordinal scale up to day 29 |