Clinical Consequences for Individuals Treated with Tocilizumab for Serious COVID-19 Infection

Abstract

There seem to currently be no therapeutic medications found for the severe coronavirus infection in 2019 (COVID-19). In light of this, it has been hypothesized that the immunomodulatory treatment known as tocilizumab can lessen the inflammatory response that occurs in the respiratory system, speed up the process of clinical benefit, lower the risk of death, and avert the need for ventilators. This randomized controlled trial (RCT) studied patients with a proven infection of SARS-CoV-2 and hyperinflammatory reactions. The inclusion criteria included fever (body temperature > 38 °C), pulmonary infiltrates, or supplemental oxygen. The patients received either conventional treatment with one dose of either tocilizumab (8 mg per kilogram of body weight) or conventional treatment only. The subjects were randomized to receive either treatment with a 1:1 ratio. A time-to-event test was conducted to determine the time to intubation or death. There was an insignificant difference between the investigated groups regarding the time to death, time to mechanical ventilation, and percentage of deaths. The conventional group’s median (IQR) hospital length of stay was 4 (3–6) days, whereas the tocilizumab therapy group was 7 (4.75–10) days. There was a substantial difference in the mechanical ventilation rates in both groups, which were 17 (34%) and 28 (56%), respectively. In hospitalized patients with severe illness and COVID-19, tocilizumab was ineffective in preventing intubation or death. Trials must be larger, however, in order to exclude the potential benefits or harms.

Evaluation of Global Post-Outbreak COVID-19 Treatment Interventions: A Systematic Review and Bibliometric Analysis of Randomized Controlled Trials

“…In the end, twenty-two studies were found to meet our inclusion criteria. 30–52 A complete representation of this study selection process is shown in Figure 1 .

Figure 1 PRISMA diagram of the study selection process of the randomized controlled trials (RCTs) included in the analysis for the treatment of COVID-19.

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“… 31 , 33 , 34 , 36 , 38 , 44 , 46 , 47 Additionally, 3 (3/22, 14%) studies were funded by both private and non-private organizations, 49 , 51 , 52 and 6 studies (6/22, 27%) reported no funding. 30 , 37 , 39 , 40 , 43 , 48 The demographic and clinical characteristics of the included studies are summarized in Table 1 .…”

“… 42 Additionally, two studies employed the anthelmintic Ivermectin in combination with antibiotics, 40 , 44 two studies utilized the corticosteroid Methylprednisolone, 41 , 43 and two studies employed the immunomodulatory agent Tocilizumab. 30 , 38 Only one study focused on immunotherapy involving convalescent plasma. 31 Furthermore, three studies incorporated supplementation strategies, including the use of vitamin C, vitamin D, and amino acid L-Arginine, 32 , 39 , 49 while one study utilized the acid-oxidizing solution Sentinox.…”

“… 33 In terms of control groups, the most frequently employed control was standard care therapy, which exhibited variations across studies, accounting for 50% (11/22). 30 , 31 , 33 , 35 , 37–39 , 44 , 46 , 48 , 51 The interventional control was used in 23% (5/22) of the studies, 40 , 41 , 43 , 47 , 49 which was the same proportion as those employing a placebo control (23%, 5/22). 32 , 34 , 42 , 50 , 52 Approximately 82% (18/22) of the studies reported both primary and secondary outcomes, with additional details available in Table S2 , more information about the most commonly outcome measures used are summarized in Table 2 .…”

“…Nonetheless, certain studies raised some concern due to limited available information regarding the concealment of the allocation sequence. 30 , 39 , 40 , 46 , 51 Furthermore, three studies were deemed to have a high risk of bias because the concealment of the allocation sequence was not implemented. 35 , 38 , 41 Regarding deviations from intended interventions, the majority of studies (20/22, 91%) showed low risk of bias, suggesting that the interventions were carried out as planned.…”