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Summary of COVID-19 tocilizumab studies

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4,116 patient tocilizumab late treatment RCT: 12% lower mortality (p=0.005), 21% lower ventilation (p=0.002), and 14% higher hospital discharge (p<0.0001).
RCT 4,116 hospitalized COVID-19 patients showing significantly lower mortality with tocilizumab.

May 2021, The Lancet, https://www.sciencedirect.com/science/article/pii/S0140673621006760, https://c19p.org/horby6

130 patient tocilizumab late treatment RCT: 7% lower mortality (p=1), 62% lower ventilation (p=0.05), and 34% lower progression (p=0.18).
RCT 130 hospitalized COVID-19 patients with moderate or severe pneumonia showing tocilizumab did not reduce WHO-CPS scores below 5 at day 4 (primary outcome), but reduced the proportion of patients needing noninvasive ventilation, high-flow oxygen, mechanical ventilation, or death by day 14. There was no significant difference in 28-day mortality.

Dec 2020, JAMA Internal Medicine, https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2772187, https://c19p.org/hermine2

705 patient tocilizumab late treatment RCT: 22% lower mortality (p=0.03).
RCT 803 critically ill COVID-19 patients showing improved outcomes with tocilizumab and sarilumab. There was only 48 sarilumab patients and the model used shrinks the posterior distribution for each intervention effect toward the overall estimate for the combined drugs. The concurrent event counts for sarilumab may be more accurate.

Apr 2021, New England J. Medicine, http://www.nejm.org/doi/10.1056/NEJMoa2100433, https://c19p.org/gordon4tz

168 patient tocilizumab late treatment PSM study: 64% lower mortality (p=0.003) and 60% lower combined mortality/intubation (p=0.001).
Retrospective 246 hospitalized patients with severe COVID-19 pneumonia showing significantly lower mortality with tocilizumab treatment.

Oct 2020, Pharmaceuticals, https://www.mdpi.com/1424-8247/13/10/317, https://c19p.org/rossi

264 patient tocilizumab late treatment PSM study: 78% lower mortality (p=0.04) and 58% lower combined mortality/intubation (p=0.03).
Retrospective 778 hospitalized COVID-19 patients with hyperinflammatory state showing tocilizumab associated with lower mortality. The 1:2 PSM analysis may be the most accurate because it provides documented, tight covariate balance across >30 baseline characteristics while automatically discarding patients whose propensity scores fall outside the zone of common support. The trimming eliminates the destabilising extreme weights that can silently bias inverse-probability–weighted estimates - yet the matched cohort still contains nearly two-thirds of the original sample, preserving adequate power. Importantly, hazard ratios for both tocilizumab and high-dose corticosteroids converge across the matched and time-dependent models, whereas IPTW produces the most extreme point estimates without providing any weight-distribution or post-weight balance diagnostics to justify that extra optimism. Given the absence of those diagnostics and the strong, transparent balance achievable through..

Feb 2021, Clinical Microbiology and Infection, https://www.sciencedirect.com/science/article/pii/S1198743X20304924, https://c19p.org/rodriguezbano

304 patient tocilizumab late treatment study: 62% lower mortality (p=0.02) and 39% lower combined mortality/intubation (p=0.02).
Retrospective 544 patients with severe COVID-19 pneumonia showing lower mechanical ventilation or death with tocilizumab.

Aug 2020, The Lancet Rheumatology, https://www.sciencedirect.com/science/article/pii/S2665991320301739, https://c19p.org/guaraldi

768 patient tocilizumab late treatment study: 60% lower combined mortality/intubation (p=0.008).
Retrospective 1,225 hospitalized patients showing lower mortality/intubation with tocilizumab.

Oct 2020, J. Clinical Pharmacy and Therapeutics, https://onlinelibrary.wiley.com/doi/10.1111/jcpt.13303, https://c19p.org/chilimuri

96 patient tocilizumab late treatment study: 32% lower mortality (p=0.34), 42% lower ventilation (p=0.03), and 45% higher hospital discharge (p=0.03).
Prospective analysis of 96 hospitalized patients with severe worsening COVID-19 pneumonia showing that tocilizumab treatment was associated with reduced need for ventilatory support and shorter time to oxygen withdrawal, however there was no significant difference in mortality.

Nov 2020, J. Clinical Immunology, http://link.springer.com/10.1007/s10875-020-00911-6, https://c19p.org/roumier

138 patient tocilizumab late treatment study: 80% lower mortality (p=0.04), 8% lower ICU admission (p=1), 44% longer hospitalization (p=0.0004), and 68% worse viral clearance (p=0.51).
Prospective cohort study of 138 hospitalized COVID-19 patients showing lower mortality with tocilizumab.

Oct 2020, EBioMedicine, https://www.sciencedirect.com/science/article/pii/S2352396420303753, https://c19p.org/masia

154 patient tocilizumab late treatment study: 45% lower mortality (p=0.02).
Retrospective 154 mechanically ventilated COVID-19 patients showing improved survival with tocilizumab. However, tocilizumab was associated with significantly higher rates of superinfection, particularly ventilator-associated pneumonia.

Jul 2020, Clinical Infectious Diseases, https://academic.oup.com/cid/article/73/2/e445/5870306, https://c19p.org/somers

65 patient tocilizumab late treatment RCT: 27% lower progression (p=0.53), 8% longer hospitalization (p=0.35), and 6% slower viral clearance (p=0.54).
RCT 65 COVID-19 patients in China showing improvement in hypoxia recovery with tocilizumab treatment, especially in moderate patients with bilateral pulmonary lesions.

Dec 2020, SSRN Electronic J., https://www.ssrn.com/abstract=3667681, https://c19p.org/wang47

79 patient tocilizumab late treatment study: 45% lower mortality (p=0.19) and 56% lower combined mortality/intubation (p=0.02).
Retrospective 79 COVID-19 patients with ARDS undergoing noninvasive ventilation showing lower risk of intubation or death with tocilizumab treatment.

Sep 2020, Critical Care, https://ccforum.biomedcentral.com/articles/10.1186/s13054-020-03306-6, https://c19p.org/menzella

438 patient tocilizumab late treatment RCT: 1% higher mortality (p=1), 24% lower ventilation (p=0.16), 41% lower ICU admission (p=0.04), and 22% faster recovery (p=0.18).
RCT 452 hospitalized patients with severe COVID-19 pneumonia showing no significant difference in clinical status or mortality at day 28 with tocilizumab. There was significantly lower ICU admission for patients not in the ICU at baseline.

Apr 2021, New England J. Medicine, http://www.nejm.org/doi/10.1056/NEJMoa2028700, https://c19p.org/rosas

92 patient tocilizumab late treatment RCT: 33% lower mortality (p=0.33).
Two open-label RCTs of 97 and 91 critically ill COVID-19 patients in France showing no significant differences with tocilizumab or sarilumab.

Feb 2022, European Respiratory J., http://erj.ersjournals.com/lookup/doi/10.1183/13993003.02523-2021, https://c19p.org/herminetz

377 patient tocilizumab late treatment RCT: 22% higher mortality (p=0.72) and 44% lower combined mortality/intubation (p=0.03).
RCT 377 hospitalized COVID-19 patients with pneumonia showing that tocilizumab significantly reduced mechanical ventilation or death by day 28, however there was no difference in mortality alone.

Jan 2021, New England J. Medicine, http://www.nejm.org/doi/10.1056/NEJMoa2030340, https://c19p.org/salama2

3,924 patient tocilizumab late treatment study: 29% lower mortality (p=0.007).
Retrospective 3,924 critically ill COVID-19 patients showing lower mortality with tocilizumab.

Dec 2020, JAMA Internal Medicine, https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2772185, https://c19p.org/gupta9

506 patient tocilizumab late treatment study: 26% lower mortality (p=0.001).
Retrospective 506 hospitalized COVID-19 patients in Spain showing lower mortality with tocilizumab.

Dec 2020, Infectious Diseases and Therapy, http://link.springer.com/10.1007/s40121-020-00373-8, https://c19p.org/ruizantoran

161 patient tocilizumab late treatment study: 38% lower mortality (p=0.05).
Retrospective cohort study of 161 hospitalized patients with severe COVID-19 pneumonia and persistent hypoxia showing survival benefit with tocilizumab.

Jul 2020, eClinicalMedicine, https://www.sciencedirect.com/science/article/pii/S258953702030211X, https://c19p.org/gokhale

2,512 patient tocilizumab late treatment study: 24% lower mortality (p=0.06).
Retrospective 2,512 hospitalized patients showing lower mortality with tocilizumab treatment within a subset of ICU patients, 143 treated with tocilizumab with adequate data, and 413 control patients.

May 2020, PLoS ONE, https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0237693, https://c19p.org/ip2tz

179 patient tocilizumab late treatment RCT: 29% lower mortality (p=0.4), 4% higher ventilation (p=1), 30% lower progression (p=0.47), and 7% higher ICU admission (p=0.49).
RCT 180 hospitalized patients with moderate to severe COVID-19 in India showing no significant difference in disease progression with tocilizumab.

May 2021, The Lancet Respiratory Medicine, https://www.sciencedirect.com/science/article/pii/S2213260021000813, https://c19p.org/soin

88 patient tocilizumab late treatment study: 43% lower mortality (p=0.27) and 8% greater improvement (p=0.86).
Retrospective 88 hospitalized COVID-19 patients showing no significant difference in clinical improvement or mortality with tocilizumab treatment.

Nov 2020, J. Medical Virology, https://onlinelibrary.wiley.com/doi/10.1002/jmv.26674, https://c19p.org/hill3

112 patient tocilizumab late treatment PSM study: 18% lower mortality (p=0.85) and 88% lower ICU admission (p=0.43).
PSM retrospective 112 hospitalized COVID-19 patients showing no significant difference in ICU admission or mortality with tocilizumab.

May 2020, Microorganisms, https://www.mdpi.com/2076-2607/8/5/695, https://c19p.org/colaneri2

621 patient tocilizumab late treatment PSM study: 29% lower mortality (p=0.004).
Retrospective 764 COVID-19 patients requiring ICU support showing lower mortality with tocilizumab. There was significantly higher use of HCQ+AZ in the treatment group, which was not adjusted for in the propensity score matching or Cox regression. 5% of tocilizumab patients did not receive HCQ compared to 17% of untreated patients (15% after PSM), suggesting substantial differences between the groups in treatment propensity (which may include other unreported treatments such as vitamin D). Authors state that "An increase in use of hydroxychloroquine was noted in patients who received tocilizumab compared with those who did not receive tocilizumab, which we do not believe had a relevant effect on our findings because most observational studies have not reported a benefit for hydroxychloroquine among hospitalised patients". However authors would know the actual effect of HCQ and AZ in their dataset. Lack of reporting and lack of adjustment suggests that HCQ+AZ may have been..

Oct 2020, The Lancet Rheumatology, https://www.sciencedirect.com/science/article/pii/S2665991320302770, https://c19p.org/biran

65 patient tocilizumab late treatment study: 53% lower mortality (p=0.15), 27% higher hospital discharge (p=0.32), and 21% greater improvement (p=0.61).
\Retrospective 65 severe COVID-19 patients showing no statistically significant differences with tocilizumab.

Jun 2020, European J. Internal Medicine, https://www.sciencedirect.com/science/article/pii/S0953620520301990, https://c19p.org/campochiaro

tocilizumab late treatment study: 35% lower mortality (p=0.51).
Retrospective 1,229 hospitalized COVID-19 patients in Spain showing that tocilizumab was associated with decreased mortality in patients with high C-reactive protein (CRP) levels (>150 mg/L) but not in those with lower CRP levels.

Feb 2021, Clinical Microbiology and Infection, https://www.sciencedirect.com/science/article/pii/S1198743X20305735, https://c19p.org/martinezsanz

193 patient tocilizumab late treatment study: 21% lower mortality (p=0.11).
Retrospective case-control study of 193 hospitalized COVID-19 patients showing a non-statistically significant trend toward lower mortality with tocilizumab treatment. When excluding intubated patients, tocilizumab was associated with significantly lower mortality.

Jun 2020, QJM: An Int. J. Medicine, https://academic.oup.com/qjmed/article/113/8/546/5860840, https://c19p.org/rojasmarte

128 patient tocilizumab late treatment study: 18% lower mortality (p=0.57).
Retrospective case-control study of 128 hospitalized COVID-19 patients with severe respiratory impairment showing no significant difference in 30-day mortality with intravenous tocilizumab treatment.

Nov 2020, J. Autoimmunity, https://www.sciencedirect.com/science/article/pii/S0896841120301335, https://c19p.org/canziani

132 patient tocilizumab late treatment PSM study: no change in mortality (p=1).
PSM retrospective 274 hospitalized COVID-19 patients showing no difference in mortality with tocilizumab.

Nov 2020, Scientific Reports, https://www.nature.com/articles/s41598-020-76187-y, https://c19p.org/tsai2

42 patient tocilizumab late treatment study: 9% lower mortality (p=0.8).
Retrospective 42 hospitalized COVID-19 patients treated with tocilizumab showing no significant differences in mortality compared to matched controls.

Oct 2020, J. Internal Medicine, https://onlinelibrary.wiley.com/doi/10.1111/joim.13163, https://c19p.org/patel11

224 patient tocilizumab late treatment study: no change in mortality (p=1).
Retrospective 224 hospitalized COVID-19 patients in the USA, showing no significant difference in mortality with tocilizumab.

Jul 2020, J. Medical Virology, https://onlinelibrary.wiley.com/doi/10.1002/jmv.26365, https://c19p.org/maeda

36 patient tocilizumab late treatment RCT: 40% higher mortality (p=0.71), 47% higher hospital discharge (p=0.26), and 40% worse recovery (p=0.71).
RCT 40 hospitalized COVID-19 patients in Iran showing no significant improvement in mortality, clinical outcomes, or oxygen therapy requirements with tocilizumab treatment. The study found no significant differences between the tocilizumab and standard of care groups in the number of patients who recovered (70.6% vs. 78.9%), hospitalization duration, or time to clinical improvement.

Feb 2024, Iranian J. Allergy, Asthma and Immunology, https://publish.kne-publishing.com/index.php/IJAAI/article/view/14956, https://c19p.org/talaschian

51 patient tocilizumab late treatment study: 40% lower hospital discharge (p=0.27), 30% shorter ventilation (p=0.16), and 57% longer hospitalization (p=0.16).
Retrospective 51 hospitalized COVID-19 patients showing significant reduction in vasopressor support duration with tocilizumab treatment, but no significant difference in other outcomes.

Jul 2020, eClinicalMedicine, https://www.sciencedirect.com/science/article/pii/S2589537020301620, https://c19p.org/kewan

1,336 patient tocilizumab late treatment study: 41% higher mortality (p=0.38).
Retrospective 1,538 hospitalized patients in Italy, showing only HCQ associated with reduced mortality. Authors analyze mortality amongst those that were alive at day 7 to avoid survival time bias due to drug recording requiring a minimum of 5 days treatment. Results were similar when analyzing the entire population.

Apr 2021, J. Clinical Medicine, https://www.mdpi.com/2077-0383/10/9/1951, https://c19p.org/derosatz

115 patient tocilizumab late treatment study: 4% higher mortality (p=0.96).
Retrospective 115 mechanically ventilated COVID-19 patients showing no mortality benefit with tocilizumab treatment.

Feb 2021, Int. J. Infectious Diseases, https://www.sciencedirect.com/science/article/pii/S1201971220325443, https://c19p.org/fisher

93 patient tocilizumab late treatment study: 117% higher mortality (p=0.53).
Retrospective 93 hospitalized COVID-19 patients with cytokine storm showing no significant difference between anakinra and tocilizumab treatment after adjusting for baseline characteristics.

Oct 2020, Int. J. Infectious Diseases, https://www.sciencedirect.com/science/article/pii/S1201971220306093, https://c19p.org/langergould

53 patient tocilizumab late treatment study: 166% higher mortality (p=0.3).
Retrospective 53 critically ill COVID-19 patients showing no difference in mortality, need for renal replacement therapy, use of antibiotics, or positive cultures with tocilizumab treatment.

Jul 2020, medRxiv, https://www.medrxiv.org/content/10.1101/2020.07.13.20149328, https://c19p.org/carvalho3

2,196 patient tocilizumab late treatment study: 58% higher mortality (p=0.06).
Retrospective 2,196 COVID-19 patients in Taiwan (49% mild cases, 44% moderate, 7% severe) showing higher mortality with tocilizumab, without statistical significance.

Aug 2024, BMC Infectious Diseases, https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-024-09654-w, https://c19p.org/yen3tz

26,445 patient tocilizumab late treatment study: 290% higher mortality (p<0.0001).
Retrospective 26,445 hospitalized COVID-19 patients in the USA, showing higher mortality with tocilizumab.

Oct 2023, HCA Healthcare J. Medicine, https://scholarlycommons.hcahealthcare.com/hcahealthcarejournal/vol4/iss5/5, https://c19p.org/ho3tz

111 patient tocilizumab late treatment study: 82% higher mortality (p=0.09).
Retrospective 111 critically ill COVID-19 patients showing that tocilizumab treatment was associated with increased secondary bacterial infections, higher mortality (35.2% vs 19.3%, p=0.020), and a trend toward more fungal infections (5.6% vs 0%, p=0.112).

Oct 2020, Frontiers in Medicine, https://www.frontiersin.org/articles/10.3389/fmed.2020.583897/full, https://c19p.org/kimmig

148 patient tocilizumab late treatment study: 71% higher mortality (p=0.05).
Retrospective 74 hospitalized COVID-19 patients treated with tocilizumab and 74 matched controls, showing higher mortality with tocilizumab.

Aug 2020, J. Medical Virology, https://onlinelibrary.wiley.com/doi/10.1002/jmv.26429, https://c19p.org/pettit

70 patient tocilizumab late treatment study: 167% higher mortality (p=0.21) and 344% higher ICU admission (p=0.01).
PSM retrospective 77 hospitalized patients receiving tocilizumab treatment and matched controls, showing no significant difference in outcomes.

Oct 2020, J. Medical Virology, https://onlinelibrary.wiley.com/doi/10.1002/jmv.26471, https://c19p.org/okoh

243 patient tocilizumab late treatment RCT: 52% higher mortality (p=0.54), 35% lower ventilation (p=0.36), 17% lower combined mortality/intubation (p=0.65), and 11% higher progression (p=0.76).
RCT 243 hospitalized patients with COVID-19 showing no significant difference in intubation or death with tocilizumab compared to placebo. Authors hypothesize that elevated interleukin-6 levels may represent host responses to infection rather than components of a self-amplifying inflammatory loop that would benefit from suppression.

Dec 2020, New England J. Medicine, http://www.nejm.org/doi/10.1056/NEJMoa2028836, https://c19p.org/stone2

85 patient tocilizumab late treatment RCT: 2% slower recovery (p=0.94).
RCT 85 patients in the USA showing no significant differences with tocilizumab treatment.

Feb 2025, NCT04479358, https://clinicaltrials.gov/study/NCT04479358, https://c19p.org/reid

129 patient tocilizumab late treatment RCT: 130% higher mortality (p=0.09) and 1% improved recovery (p=0.96).
RCT 129 hospitalized patients with severe or critical COVID-19 in Brazil showing no benefit and potential harm with tocilizumab treatment.

Jan 2021, BMJ, https://www.bmj.com/lookup/doi/10.1136/bmj.n84, https://c19p.org/veiga

123 patient tocilizumab late treatment RCT: 110% higher mortality (p=0.61), 26% higher ICU admission (p=0.76), and 26% lower hospital discharge (p=0.76).
RCT 126 hospitalized COVID-19 patients with pneumonia showing no significant benefit of tocilizumab treatment.

Dec 2020, JAMA Internal Medicine, https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2772186, https://c19p.org/salvarani2
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