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. 2021 Jan-Mar;33(1):31–37. doi: 10.5935/0103-507X.20210003

Table 1.

Coalition COVID-19 Brazil randomized clinical trials

Study name
(registry)
Population Interventions Actual or estimat-ed number
of participants
Coalition I
(NCT04322123)
Adult hospitalized patients with proven or suspected SARS-CoV-2 infection
Needing either no oxygen or a maximum of 4L/minute of supplemental oxygen
14 or fewer days since symptom onset
Arm 1: HCQ
Arm 2: HCQ + AZM
Arm 3: SOC
667 (actual)
Coalition II
(NCT04321278)
Adult hospitalized patients with proven or suspected SARS-CoV-2 infection
At least one of the following severity criteria: use of oxygen supplementation of more than 4L/minute flow, use of high-flow nasal cannula, use of noninvasive positive-pressure ventilation, or use of mechanical ventilation
14 or fewer days since symptom onset
Arm 1: AZM + SOC
Arm 2: SOC
447 (actual)
Coalition III
(NCT04327401)
Adult hospitalized patients with proven or suspected SARS-CoV-2 infection
Receiving mechanical ventilation within 48 hours of meeting criteria for moderate to severe ARDS according to the Berlin definition*
Arm 1: dexamethasone
Arm 2: SOC
299 (actual)
Coalition IV
(NCT04394377)
Adult hospitalized patients with confirmed diagnosis of COVID-19
Onset of symptoms leading to hospitalization < 14 days
and D-dimer ≥ 3 x the upper limit of normal
Arm 1: full anticoagulation
Arm 2: SOC
600 (estimated)
Coalition VI
(NCT04403685)
Adult hospitalized patients with confirmed SARS-CoV-2 infection
More than 3 days of symptoms related to COVID-19
Computed tomography (or chest X-ray) with COVID-19 alterations
Need for oxygen supplementation to keep SpO2 > 93%, or need for mechanical ventilation for less than 24 hours before the randomization
At least two of the following inflammatory tests above the cutoff: D-dimer > 1,000ng/mL, C-reactive protein > 5mg/dL, Ferritin > 300mg/dL, Lactate dehydrogenase > upper-level limit
Arm 1: tocilizumabe
Arm 2: SOC
150 (estimated)

SARS-CoV-2 - severe acute respiratory syndrome coronavirus 2; HCQ - hydroxychloroquine; AZM - azithromycin; SOC - standard of care; ARDS - acute respiratory distress syndrome; SpO2 - oxygen saturation.

*

Acute respiratory failure within 1 week of a clinical insult or new worsening respiratory symptoms AND chest image with bilateral opacities - not fully explained by effusions, lobar/lung collapse, or nodules AND respiratory failure not fully explained by cardiac failure or fluid overload AND positive end-expiratory pressure of 5cmH2O or more AND a partial pressure of arterial blood oxygen to fraction of inspired oxygen ratio of 200 or less.