drugset / Trial / NCT04358081

Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease

NCT04358081

Phase 3 Completed 20 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Two recent studies have suggested that in patients with Covid19, treatment with hydroxychloroquine may shorten the duration of symptoms and improve viral clearance, an effect that appears most pronounced when combined with azithromycin. Hydroxychloroquine treatment may inhibit viral nucleic acid-mediated activation of various innate immune pathways, as well as blockade of lysosomal functions in cell types relevant for viral entry and antigen presentation. The purpose of the study was to determine if oral hydroxychloroquine monotherapy, or in combination with azithromycin results in clinical benefit in patients hospitalized with COVID19 pneumonia.

Timeline

Start
2020-05-01
Primary completion
2020-07-27
Completion
2020-07-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 250 mg
Subject Hydroxychloroquine Small molecule 200 mg Oral

Indications