Table 1.
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.