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Tocilizumab plus standard care versus standard care in patients in India with moderate to severe COVID-19-associated cytokine release syndrome (COVINTOC): an open-label, multicentre, randomised, controlled, phase 3 trial

Soin et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(21)00081-3, COVINTOC, CTRI/2020/05/025369, May 2021
https://c19early.org/soin.html
Mortality 29% Improvement Relative Risk Ventilation -4% Progression 30% ICU admission -7% Tocilizumab  COVINTOC  LATE TREATMENT  RCT Is late treatment with tocilizumab beneficial for COVID-19? RCT 179 patients in India (May - August 2020) Lower mortality (p=0.4) and progression (p=0.47), not sig. c19early.org Soin et al., The Lancet Respiratory Me.., May 2021 Favorstocilizumab Favorscontrol 0 0.5 1 1.5 2+
RCT 180 hospitalized patients with moderate to severe COVID-19 in India showing no significant difference in disease progression with tocilizumab.
risk of death, 29.1% lower, RR 0.71, p = 0.40, treatment 11 of 91 (12.1%), control 15 of 88 (17.0%), NNT 20.
risk of mechanical ventilation, 4.1% higher, RR 1.04, p = 1.00, treatment 14 of 91 (15.4%), control 13 of 88 (14.8%).
risk of progression, 29.7% lower, RR 0.70, p = 0.47, treatment 8 of 91 (8.8%), control 11 of 88 (12.5%), NNT 27.
risk of ICU admission, 7.3% higher, RR 1.07, p = 0.49, treatment 71 of 91 (78.0%), control 64 of 88 (72.7%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Soin et al., 31 May 2021, Randomized Controlled Trial, India, peer-reviewed, median age 56.0, 20 authors, study period 30 May, 2020 - 31 August, 2020, trial CTRI/2020/05/025369 (COVINTOC). Contact: avisoin1@gmail.com.
Tocilizumab plus standard care versus standard care in patients in India with moderate to severe COVID-19-associated cytokine release syndrome (COVINTOC): an open-label, multicentre, randomised, controlled, phase 3 trial
Arvinder S Soin, MSc Kuldeep Kumar, Narendra S Choudhary, MD Pooja Sharma, MD Yatin Mehta, Sushila Kataria, MD Deepak Govil, MD Vikas Deswal, Pawan Dhruva Chaudhry, Pawan Kumar Singh, Ashish Gupta, Vikas Agarwal, Suresh Kumar, Shashikala A Sangle, Rajesh Chawla, Suneetha Narreddy, MD Rahul Pandit, Vipul Mishra, Manoj Goel, Athimalaipet V Ramanan
The Lancet Respiratory Medicine, doi:10.1016/s2213-2600(21)00081-3
Background Global randomised controlled trials of the anti-IL-6 receptor antibody tocilizumab in patients admitted to hospital with COVID-19 have shown conflicting results but potential decreases in time to discharge and burden on intensive care. Tocilizumab reduced progression to mechanical ventilation and death in a trial population enriched for racial and ethnic minorities. We aimed to investigate whether tocilizumab treatment could prevent COVID-19 progression in the first multicentre randomised controlled trial of tocilizumab done entirely in a lower-middle-income country. Methods COVINTOC is an open-label, multicentre, randomised, controlled, phase 3 trial done at 12 public and private hospitals across India. Adults (aged ≥18 years) admitted to hospital with moderate to severe COVID-19 (Indian Ministry of Health grading) confirmed by positive SARS-CoV-2 PCR result were randomly assigned (1:1 block randomisation) to receive tocilizumab 6 mg/kg plus standard care (the tocilizumab group) or standard care alone (the standard care group). The primary endpoint was progression of COVID-19 (from moderate to severe or from severe to death) up to day 14 in the modified intention-to-treat population of all participants who had at least one postbaseline assessment for the primary endpoint. Safety was assessed in all randomly assigned patients. The trial is completed and registered with the Clinical Trials Registry India (CTRI/2020/05/025369). Findings 180 patients were recruited between May 30, 2020, and Aug 31, 2020, and randomly assigned to the tocilizumab group (n=90) or the standard care group (n=90). One patient randomly assigned to the standard care group inadvertently received tocilizumab at baseline and was included in the tocilizumab group for all analyses. One patient randomly assigned to the standard care group withdrew consent after the baseline visit and did not receive any study medication and was not included in the modified intention-to-treat population but was still included in safety analyses. 75 (82%) of 91 in the tocilizumab group and 68 (76%) of 89 in the standard care group completed 28 days of follow-up. Progression of COVID-19 up to day 14 occurred in eight (9%) of 91 patients in the tocilizumab group and 11 (13%) of 88 in the standard care group (difference -3•71 [95% CI -18•23 to 11•19]; p=0•42). 33 (36%) of 91 patients in the tocilizumab group and 22 (25%) of 89 patients in the standard care group had adverse events; 18 (20%) and 15 (17%) had serious adverse events. The most common adverse event was acute respiratory distress syndrome, reported in seven (8%) patients in each group. Grade 3 adverse events were reported in two (2%) patients in the tocilizumab group and five (6%) patients in the standard care group. There were no grade 4 adverse events. Serious adverse events were reported in 18 (20%) patients in the tocilizumab group and 15 (17%) in the standard care group; 13 (14%) and 15 (17%) patients died during the..
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Late treatment
is less effective
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