Table 2.
Study design and criteria
| Reference | Site | Design | Dates | Follow-up | Inclusion criteria | Primary outcome |
|---|---|---|---|---|---|---|
| BACC Bay Tocilizumab | USA | Randomized, double-blind, placebo-controlled trial | April 20 to June 15, 2020 | 28 days | SARS-CoV2 + fever + pulmonary infiltrates or need for supplemental oxygen. At least one of the following laboratory criteria also had to be fulfilled: a CRP 50 mg/L, ferritin > 500 ng/ml, d-dimer level > 1000 ng/ml, or LDH level > 250 U/L | Intubation (or death, for patients who died before intubation) |
| RCT-TCZ-COVID | Italy | Cohort-embedded, investigator-initiated, multicenter, open-label, randomized clinical trial | March 31 to June 11, 2020 | 28 days | SARS-CoV2 + fever + (PaO2/FiO2) ratio between 200 and 300 mg Hg, and/or CRP levels of > 10 mg/dL and/or CRP level increased to at least twice the admission measurement | Entry into ICU with invasive mechanical ventilation, death from all causes, or Pao2/Fio2 ratio less than 150 mm Hg |
| CORIMUNO-TOCI-1 | France | Prospective, open-label randomized clinical trial | March 31 to April 18, 2020 | 60 days | SARS-CoV2 + or CT chest findings + moderate, severe, or critical pneumonia O2 > 3 L/min, WHO-CPS score ≥ 5 | Scores higher than 5 on the WHO-CPS scale on day 4 and survival without need of ventilation (including non-invasive ventilation) at day 14 |
| COVACTA | Global | Multicenter, randomized, double-blind, placebo-controlled phase III trial | Apri 3 to May 28, 2020 | 28 days | SARS-CoV2 + chest Xray or CT findings + SpO2 < 93% or PaO2/FiO2 ratio < 300 | Clinical status at day 28, as assessed on the seven-category ordinal scale |
| REMAP-CAP | Global | International, adaptive platform, open-label randomized controlled trial | April 19 to November 19, 2020 | 90 days | Confirmed COVID-19 who were admitted to the ICU and were receiving respiratory or cardiovascular organ support | Number of respiratory and cardiovascular organ support–free days up to day 21 |
| EMPACTA | Global | Double-blinded, placebo-controlled, multicenter trial | N/A | 60 days | Confirmed COVID-19 along with radiologic features who were saturating below 94% while breathing ambient air | Mechanical ventilation (invasive mechanical ventilation or extracorporeal membrane oxygenation) or death by day 28 |
| RECOVERY | UK | Randomized, controlled, open-label, platform trial | N/A | 28 days | Clinical evidence of progressive COVID-19 (defined as oxygen saturation < 92% on room air or receiving oxygen therapy, and CRP ≥ 75 mg/L) | All-cause mortality |
| TOCIBRAS | Brazil | Multicenter, randomized, open-label, parallel group, superiority trial | May 8 to July 17, 2020 | 15 days | Confirmed severe or critical COVID-19 + receiving supplemental or receiving mechanical ventilation for < 24 h before analysis + At least two of the following criteria had to be met: D-dimer > 1000 ng/mL, CRP > 50 mg/L, ferritin > 300 μg/L, or LDH greater than the upper limit of normal | Clinical status at 15 days evaluated with the use of a seven-level ordinal scale |
| COVINTOC | India | Open-label, randomized, multicenter, controlled phase III trial | May 30 to August 31, 2020 | 28 days | Confirmed COVID-19 + moderate to severe disease (moderate defined as respiratory rate 24/ min and SpO2 90–94%; and severe defined as respiratory rate ≥ 30/min or SpO2 < 90% in ambient air or ARDS or septic shock) | Proportion of patients with progression of COVID-19 from moderate to severe or from severe to death up to day 14 |