Reis (Lopinavir-ritonavir) (TOGETHER), 2021 NCT04403100
lopinavir/ritonavir (n=244) vs. placebo (n=227)
randomized controlled trial
some concerns about risk of bias
Lopinavir-ritonavir
Lopinavir-ritonavir: loading dose of 800 mg and 200 mg, respectively, every 12 hours followed by 400 mg and 100 mg, respectively, every 12 hours for the next 9 days.
Placebo
Corresponding tablets of inert material (talc). Placebo bottles were matched for the same number of tablets as active lopinavir-ritonavir.
3 arms: Hydroxychloroquine, lopinavir-ritonavir or placebo (1:1:1).
COVID 19 outpatients
Patients 18 years or older; reported less than 8 days since onset of flulike symptoms or chest computerized tomography scan consistent with COVID-19 and at least one additional criterion for high risk: aged 50 years or older; presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, or emphysema; diabetes requiring oralmedication or insulin; hypertension requiring treatment; known cardiovascular diseases (congestive heart failure of any etiology, documented coronary artery disease, clinically manifest miscellaneous heart disease); symptomatic lung disease on chronic treatment; history of transplantation; obesity (body mass index 30 [calculated as weight in kilograms divided by height in meters squared]); immunocompromised status due to disease (eg, those living with HIV with a CD4 T-cell count of <200 cells/mm3, confirmed malignant neoplasm); immunocompromised status due to medication (eg, people taking 10 mg or more of prednisone equivalents a day); and patients with cancer.
Double-blind.
10 cities in Brazil.
The trial was stopped after the interim analysis for futility with a sample size of 685 patients.