PIII COVINTOC study in India (n=180) found tocilizumab did not reduce the risk of progression of COVID-19 up to day 14 when compared to standard of care (9% versus 13% respectively; p=0.42) in adults admitted to hospital with moderate to severe COVID-19 .
PIII COVACTA study (n=452, NCT04320615) published in NEJM .
Results of REMAP-CAP trial published in NEJM .
RECOVERY trial demonstrates that tocilizumab reduces the risk of death in hospitalised pts with severe COVID-19 and shortens length of hospital stay and need for ventilation. Pts (n=2022) received i.v tocilizumab + usual care or usual care alone (n=2094) and 82% of pts accross gps were taking a steroid, usually dexamethasone. In the tocilizumab group, 29% of pts died vs. 33% in the usual care only group (RR: 0·86; [95% CI: 0·77 to 0·96; p=0·007), an absolute difference of 4% or NNT of 25 pts treated to save 1 life. Tocilizumab increased probability of discharge within 28 days from 47% to 54% (RR: 1·23, [95% CI 1·12 to 1·34], p<0·0001). These benefits were seen in all subgroups, including those requiring oxygen through to pts ventilated in ITU. In those not ventilated, tocilizumab reduced the chance of progressing to invasive mechanical ventilation or death from 38% to 33% (risk ratio 0·85, [95% CI 0·78 to 0·93], p=0·0005). There was no evidence that tocilizumab had any effect on the chance of successful cessation of invasive mechanical ventilation .
A Brazilian study (n=129; NCT04403685) was stopped early, as tocilizumab was associated with higher mortality at 15 days versus standard care (component of the primary outcome; 17% v 3%; OR 6.42, 95% CI 1.59 to 43.2), with no clinical benefit noted .
PIII EMPACTA trial is published; in hospitalised patients with Covid-19 (n=389), the addition of tocilizumab to standard care reduced the likelihood of progression to mechanical ventilation or death by 28 days (12.0% v 19.3%; HR 0.56; 95% CI 0.33-0.97; p=0.04) but did not improve overall survival .
Cohort study (n=3,924) found those treated with tocilizumab had a lower risk of death vs those not given tocilizumab (HR 0.71, 95%CI 0.56-0.92 after median follow up of 27 days). 30 day mortality was 27.5% for tocilizumab vs 37.1% for no tocilizumab (p<0.05) .
PII RCT (NCT04346355; n=126) found tocilizumab did not reduce the rate of disease progression (entry to ICU, requirement for mechanical ventilation, death or significant worsening of Pao2/Fio2 ratio) vs placebo in patients with COVID-19 pneumonia and Pao2/Fio2 ratio between 200 and 300 mm Hg .
PII CORIMUNO-19 RCT (n=131) found that tocilizumab did not improve the rate of reduction of the WHO Clinical Progression Scale score to <5 vs placebo, however fewer patients needed noninvasive or mechanical ventilation or died (24% vs 36%, HR 0.58, 90%CI 0.33-1.00) .
PIII EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received tocilizumab plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the tocilizumab arm versus 19.3% in the placebo arm .
In the CHIC study, patients treated with a course of high-dose methylprednisolone plus tocilizumab escalation (days 2-5) if required were more likely to achieve improvement in respiratory status (HR 1.79; 95% CI 1.20-2.67) and on average 7 days earlier than historical controls .
PII MARIPOSA study (NCT04363736) is recruiting 100 patients and comparing two doses of tocilizumab (8mg/kg and 4mg/kg) plus standard of care. First patient and last patient was enrolled in Q2 20 .
PIII COVACTA trial (n=330) of tocilizumab in patients hospitalised with severe COVID-19-related pneumonia fails to meet primary end-point of improved clinical status, or key secondary end-point of reduced patient mortality .
In a study conducted by the Italian drug regulator (n=126) has concluded that tocilizumab did not improve severe respiratory symptoms, reduce ICU visits or reduce mortality rates any more than standard care in patients with early-stage COVID-19 pneumonia .
PIII EMPACTA study (Evaluating Minority Patients with Actemra, NCT04372186) initiated. It will evaluate the safety and efficacy of tocilizumab vs. placebo (both with std care) in ~379 pts hospitalised with COVID-19 pneumonia in ~40 facilities accross the US that largely treat minority patient populations. The primary outcome measure is the cumulative proportion of pts requiring mechanical ventilation by day 28 and data are expected in Aug 20. [8,9]
Positive results reported from a small French, randomised controlled trial of tocilzumab in 129 pts with moderate to severe COVID-19 penumonia. The trial was conducted by the academic research collaboration COVID-19 Assistance Publique-Hôpitaux de Paris / Universités / INSERM-REACTing. Pts were randomised to receive std treatment + tocilizumab or std treatment only. The primary efficacy endpoint(combination of the need for mechanical or non-invasive ventilation or death on day 14) was achieved in a significantly lower proportion of pts in the tocilizumab arm. The results of this trial are being prepared for submision for publication in a peer-reviewed journal. 
COVACTA trial (NCT04320615; n=330) has begun recruitment in the US and Europe (UK sites listed but not yet recruiting) .
Several clinical trials of tocilizumab in treatment of COVID-19 are already underway in China. USTC researchers are running a study comparing tocilizumab with conventional therapy in 188 patients. Another team at Peking University First Hospital is investigating a combination of favipiravir and tocilizumab (NCT04310228; n=150) .
PIII trial is randomized, double-blind and placebo-controlled (COVACTA) to evaluate the safety and efficacy of intravenous tocilizumab added to standard of care in adult patients hospitalized with severe COVID-19 pneumonia compared to placebo plus standard of care. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will be followed for 60 days post-randomization, and an interim analysis will be conducted to look for early evidence of efficacy .
Roche announce initiation of PIII clinical trial in hospitalised patients with severe COVID-19 pneumonia. Enrolment is expected to begin early April with a target of approximately 330 patients globally, including the US .