Table 6.
Overview of approved immunomodulator treatments discussed in this paper.
Immune-based therapy | Drug | Benefits | Negative indication | Clinical trial identifier | Participants |
---|---|---|---|---|---|
Corticosteroids | Hydrocortisone | improvement in organ support–free days within 21 days | / | NCT02735707 (REMAP-CAP) | patient admission to an ICU (n = 384) |
Methylprednisolone | / | no significant effect on the primary outcome (composite of death, admission to the intensive care unit, or requirement for noninvasive ventilation) | GLUCOCOVID | hospitalized patients receiving oxygen without mechanical ventilation (n = 64) | |
Dexamethasone | reduction in mortality at day 28 in patients on mechanical ventilation and those receiving supplementary oxygen | the mortality benefit was not found among those not receiving any respiratory support at randomization | NCT04381936 (RECOVERY) | hospitalized patient (n = 6425) | |
Dexamethasone | improve the number of ventilator-free at day 28 | no significant difference in all-cause mortality, ICU-free days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days | NCT04327401 (CoDEX) | patients with moderate to severe ARDS in ICUs (n = 299) | |
Hydrocortisone | / | no significantly in reducing treatment failure (death or persistent respiratory support) at day 21 | NCT02517489 (CAPE-COVID) | patients admitted to the ICU for COVID-19-related acute respiratory failure (n = 149) | |
JAK inhibitor | Baricitinib (mainly) | reduction in mortality at day 28 | / | NCT04381936 (RECOVERY) | hospitalized patient (n = 8156) |
Baricitinib | reduction in mortality at day 28 and day 60 | no significant reduction in the frequency of disease progression | NCT04421027 (COV-BARRIER) | hospitalized adults with COVID-19 (n = 1525) | |
Baricitinib + remdesivir | reducing recovery time and accelerating improvement in clinical status (notably among those receiving high-flow oxygen or noninvasive ventilation) |
no significant difference in mortality at day 28 compared with remdesivir alone | NCT04401579 (ACTT2) | hospitalized adults with COVID-19 (n = 1033) | |
Tofacitinib | lower risk of death or respiratory failure through day 28. | no significant difference in death from any cause | NCT04469114 (STOP-COVID) | hospitalized patients (n = 289) | |
IL-6 antagonist | Tocilizumab | reduction in mortality with 28-days, reduce duration of hospitalization | no benefit was found among those not receiving invasive mechanical ventilation | NCT04381936 (RECOVERY) | severe ARDS hyperinflammatory states (N = 4116) |
Tocilizumab and Sarilumab | Improving organ support–free days, 90-day survival, time to ICU, hospital discharge, and WHO ordinal scale at day 14 | / | NCT02735707 (REMAP-CAP) | patients need organ support in the ICU (n = 895) | |
Tocilizumab | / | not effective for preventing intubation or death in moderately ill hospitalized patients with COVID-19 | NCT04356937 | SARS-CoV-2 infection, hyperinflammatory states (n = 243) |
ICU = intensive care unit; ARDS = acute respiratory distress syndrome; COVID-19 = coronavirus disease 2019; WHO = world health organization; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.