’Grey literature’ concerning randomised controlled trials
| Drug | Study name | Author, year | Study groups | Efficacy | Safety | Risk of bias |
| Tocilizumab | REMAP-CAP | Gordon et al 2020 | SOC* SOC* +TCZ SOC* +SARI | Compared with control, median adjusted ORs for hospital survival were 1.64 (95% CrI 1.14, 2.35) for TCZ and 2.01 (95% CrI 1.18 to 4.71) for SARI. TCZ and SARI were effective across all secondary outcomes, including 90-day survival, time to ICU and hospital discharge and improvement in the WHO ordinal scale at day 14. | Nine serious adverse events reported in the TCZ group including one secondary bacterial infection, five bleeds, two cardiac events and one deterioration in vision. Eleven serious adverse events in the control group, four bleeds and seven thromboses. No serious adverse events in the SARI group. | Unclear |
| TCZ | COVACTA | Rosas et al 2020 | SOC† +PBO SOC† +TCZ | No difference between groups in mortality at day 28 between TCZ (19.7%) and PBO (19.4%) (difference, 0.3% (95% CI −7.6 to 8.2); nominal p=0.94). Post hoc analysis on patients not on IMV: Among patients not receiving MV at randomisation, less patients in the TCZ group experienced any clinical failure at day 28 compared with PBO (29% vs 42.2%) HR 0.614; 95% CI 0.40 to 0.94; nominal p=0.03). | Serious adverse events occurred in 34.9% of 295 patients in the TCZ arm and 38.5% of 143 in the PBO arm. | Unclear |
*Standard care of each recruiting site. Since participants could be randomised to other interventions within other domains, depending on domains active at the site, patient eligibility and consent (see www.remapcap.org). Randomisation to the corticosteroid domain for COVID-19 closed on 17 June 2020.12 Thereafter, corticosteroids were allowed as per recommended standard of care.
†Standard care per local practice (antiviral treatment, low-dose steroids, convalescent plasma and supportive care) was permitted; however, concomitant treatment with another investigational agent (except antivirals) or any immunomodulatory agent was prohibited.
AE, adverse event; AZT, azithromycin; COL, colchicine; CrI, credibility interval; DEX, dexamethasone; HCQ, hydroxychloroquine; HCT, hydrocortisone; ICU, intensive care unit; MTP, methylprednisolone; PBO, placebo; RUXO, ruxolitinib; SAE, severe adverse event; SARI, sarilumab; SE, standard error; SOC, standard of care; TCZ, tocilizumab.