About the Study

  • The purpose of this study was to understand if taking lopinavir/ritonavir, hydroxychloroquine, or hydroxychloroquine/azithromycin may be used to help treat people infected with early COVID-19 infection.
  • We studied these medications in people who are well enough to be treated in their homes.
  • We studied the medication in people who are at increased risk for developing complications of SARS-CoV-2 infection, and also people who do not have identified risk factors for more severe infection.

Why these drugs?

LPV/r is an antiviral medication that is FDA approved to treat HIV infection. In the lab and in animal models, LPV/r has activity against coronaviruses. LPV/r is also known as Kaletra. The use of Kaletra in this study is investigational. This drug can be associated with diarrhea, nausea, and abdominal pain.

HCQ is currently FDA approved to treat malaria and autoimmune diseases. In small studies conducted in a lab, scientists observed that cells that were treated with HCQ blocked coronaviruses (including SARS-CoV-2) from entering the cells and infecting them.

Azithromycin is an antibiotic FDA approved to treat pneumonia and sinus infections. Azithromycin has shown antiviral activity in the lab against Zika, Ebola, and rhinoviruses.

This study was led by International Clinical Research Center/Department of Global Health, University of Washington, along with the UW Virology Research Clinic, Cook County Health/RMR CORE Center – Chicago, Boston Medical Center, SUNY Upstate, and Tulane University. This study was part of a $125 million initiative launched by the Bill & Melinda Gates Foundation, Welcome Trust, and Mastercard to speed development and access to therapies against the respiratory virus that has spread throughout the world. The three organizations are partners in the COVID-19 Therapeutics Accelerator.