Table 3 LACTT objectives and endpoints
Primary objectives | Primary endpoints |
 1. To evaluate the clinical efficacy of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir added on to standard therapy relative to standard therapy alone for treatment of individuals with laboratory-confirmed COVID-19  1.1 To evaluate the clinical efficacy of chloroquine phosphate added on to standard therapy relative to standard therapy alone for treatment of individuals with laboratory-confirmed COVID-19  1.2 To evaluate the clinical efficacy of hydroxychloroquine sulphate added on to standard therapy relative to standard therapy alone for treatment of individuals with laboratory-confirmed COVID-19  1.3 To evaluate the clinical efficacy of lopinavir/ritonavir added on to standard therapy relative to standard therapy alone for treatment of individuals with laboratory-confirmed COVID-19 | Seven-point ordinal scale assessed on day 15 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation 7. Death |
Secondary objectives | Secondary endpoints |
 1. To evaluate the effect of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir added on to standard therapy compared to standard therapy on the rate of progression/resolution of COVID-19  1.1 To evaluate the effect of chloroquine phosphate added on to standard therapy compared to standard therapy on the rate of progression/resolution of COVID-19  1.2 To evaluate the effect of hydroxychloroquine sulphate added on to standard therapy compared to standard therapy on the rate of progression/resolution of COVID-19  1.3 To evaluate the effect of lopinavir/ritonavir added on to standard therapy compared to standard therapy on the rate of progression/resolution of COVID-19 | 1. Clinical status on the 7-point ordinal scale on days 3, 5, 8, 11 and 29 2. National Early Warning Score assessed daily while hospitalized and on day 15 3. Duration of supplemental oxygen 4. Duration of mechanical ventilation 5. Duration of hospitalization or isolation 6. SARS-CoV-2 clearance time based on samples taken on days 3, 5, 8, 11, 15 and 29 |
 2. To evaluate the safety of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir added on to standard therapy compared to standard therapy in the treatment of individuals with laboratory-confirmed COVID-19  2.1 To evaluate the safety of chloroquine phosphate added on to standard therapy compared to standard therapy in the treatment of individuals with laboratory-confirmed COVID-19  2.2 To evaluate the safety of hydroxychloroquine sulphate added on to standard therapy compared to standard therapy in the treatment of individuals with laboratory-confirmed COVID-19  2.3 To evaluate the safety of lopinavir/ritonavir added on to standard therapy compared to standard therapy in the treatment of individuals with laboratory-confirmed COVID-19 | 1. Cumulative incidence of severe adverse events up to and including day 29 2. Changes in laboratory safety indices assessed on days 1, 8 and 15—haemoglobin concentration, platelet count, white blood cell count, glucose, creatinine, total bilirubin, ALT and AST |