Table 2.
Characteristic of retrospective case-control and prospective cohort studies included in the analysis of anti-IL-6R treatment in severe COVID-19.
| Author | Location | No. of TCZ/STD treated patients | TCZ eligibility criteria | Therapy | Outcome at days | Survival rate (HR, 95% CI) | Mortality |
Required IMV |
ICU admission |
Discharge |
Adverse effect* |
|||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TCZ | STD | TCZ | STD | TCZ | STD | TCZ | STD | TCZ | STD | |||||||
| Campochiaro et al. | Italy | 32/33 | 2x Positive RT-PCR of SARS-CoV-2 on nasopharyngeal swab; hyper-inflammation (CRP, ≥100 mg/L or r ferritin ≥ 900 ng/mL); severe respiratory involvement (chest X-ray/CT, SaO2 ≤ 92%, PaO2:FiO2 ≤ 300 mmHg) | STD: HCQ, lopinavir/ritonavir, ceftriaxone, azithromycin, anti-coagulation prophylaxis TCZ: STD + TCZ 400 mg IV (1 time, 24 h interval for the second dose) |
28 | HR for death 0.44, 95% CI 0.167–1.184, p = 0.122 | 5/32 | 11/33 | 0/32 | 1/33 | – | – | 20/32 | 16/33 | 4/32a 5/32b |
4/33 6/33 |
| Capra et al. | Italy | 62/23 | Confirmed SARS-CoV-2, and one of the following criteria: RR ≥ 30 breaths/min, SpO2 ≤ 93%, PaO2/FiO2 ≤ 300 mmHg, severe respiratory involvement by chest X-ray | STD: HCQ, lopinavir, ritonavir TCZ: STD + TCZ 400 mg IV or 324 mg SC (1 time) |
35 | HR for death 0.035, 95% CI 0.004–0.347, p = 0.004 | 2/62 | 11/23 | – | – | – | – | 23/62 | 8/23 | – | – |
| Colaneri et al. | Italy | 21/91 | Confirmed SARS-CoV-2, CRP > 5 mg/dl, PCT < 0.5 ng/mL, PaO2:FiO2 < 300; ALT < 500 U/L | STD: HCQ, azithromycin, prophylactic dose of low weight heparin, and methylprednisolone TCZ: STD + TCZ 400 mg IV |
7 | – | 5/21 | 19/91 | – | – | 3/21 | 12/91 | – | – | 0/21b | 0/91 |
| Klopfensteina et al. | France | 20/25 | Confirmed SARS-CoV-2; failure of standard treatment, oxygen therapy ≥ 5 l/min, >25% of lung damages on chest computed tomography (CT) scan, and ≥ 2 parameters of inflammation (high level of ferritin, CRP, D-dimers, lymphopenia, and LDH) | STD: HCQ, lopinavir-ritonavir, antibiotics, corticosteroids TCZ: STD + TCZ (1 or 2 doses) |
11 | – | 5/20 | 12/25 | 0/20 | 8/25 | 0/20 | 11/25 | 11/20 | 11/25 | – | – |
| Quartuccio et al. | Italy | 42/69 | Confirmed SARS-CoV-2; level of CRP and IL-6 | STD: antivirals, antimalarials, glucocorticoids, antibiotics, LMWH TCZ: STD + TCZ 8 mg/kg IV single infusion |
12 | – | 4/42 | 0/69** | – | – | – | – | – | – | – | – |
| Author | Location | No. of patients | TCZ eligibility criteria | Therapy | Outcome (HR, 95% CI) |
||
|---|---|---|---|---|---|---|---|
| Adverse effect | Clinical improvement | Survival rate | |||||
| Morena et al. | Italy | 51 | Confirmed SARS-CoV-2, age ≥ 18 years, RR ≥ 30 min–1, SpO2 < 93%, PaO2/FiO2 < 250 mmHg, IL-6 plasma level > 40 pg/mL. | TCZ 400 mg IV or 8 mg/kg (1 time, 12 h interval for the second dose) | Increased AST/ALT (29%), Bacteremia (27%) | HR 67% (95% CI 56–68) Clinical improvement based on severity or discharge, 30 days follow up |
Mortality rate 27%, 30 days follow up |
| Sciascia et al. | Italy | 56 | Confirmed SARS-CoV-2, SpO2 < 93%, PaO2/FiO2 < 300 mmHg, CRP or D-dimer > 10× normal values, LDH > 2× the upper limits, ferritin > 1000 ng/mL | TCZ 8 mg/kg IV or 324 mg SC (1 or 2 doses) | No adverse effect was reported | – | TCZ increased survival rate, HR 2.2 (95% CI 1.3–6.7), p < 0.05, Survival rate according to D-dimer levels, 14 days follow up |
TCZ, Tocilizumab; STD, Standard treatment; *adverse effects including secondary infectiona or severe hepatic injury/increase ALT/ASTb; **milder clinical presentation; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CRP, C-reactive protein; CT, computerized tomography; FiO2, fraction of inspired oxygen (FiO2); HCQ, hydroxychloroquine; ICU, intensive care unit; IV, intravenous; IMV, invasive mechanical ventilation; LDH lactate dehydrogenase; PaO2, partial pressure of oxygen; PCT, procalcitonin; RT-PCR, reverse transcription polymerase chain reaction; SC, subcutaneous, SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.