Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19

https://doi.org/10.1016/j.eclinm.2020.100645

NCT04349592 study enrolled 456 participants (152 in each of three groups: HC+AZ, HC, placebo) between 13 April and 1 August 2020. HC+AZ, HC, and placebo groups had 6 (3.9%), 7 (4.6%), and 9 (5.9%) participants go off study medications before completing the medication course (p = 0.716). Day six PCR results were available for all 152 HC+AZ participants, 149/152 (98.0%) HC participants, and 147/152 (96.7%) placebo participants. Day six ITT analysis found no difference (p = 0.821) in groups’ proportions achieving virologic cure: HC+AZ 16/152 (10.5%), HC 19/149 (12.8%), placebo 18/147 (12.2%). Day 14 assessment also showed no association (p = 0.072) between study group and viral cure: HC+AZ 30/149 (20.1%,), HC 42/146 (28.8%), placebo 45/143 (31.5%). There were no serious adverse events. HC+/-AZ does not facilitate virologic cure in patients with mild or asymptomatic Covid-19.

Tags: ,