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Trial to Evaluate the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons with COVID-19

Clinical Trial Title: 
A randomized, double-blind, placebo-controlled trial to evaluate the efficacy of hydroxychloroquine and azithromycin to prevent hospitalization or death in persons with COVID-19.
Clinical Trial Protocol ID: 
20041604
Clinical Trial Investigator Name: 
Beverly E. Sha, MD
Clinical Trial Protocol Description: 

Participants will be randomized 1:1 to receive active/placebo study treatment as follows: HCQ/Placebo 400 mg orally twice a day on Day 0, followed by 200 mg orally twice a day for 6 days, and Azithro/Placebo 500 mg once on Day 0, followed by 250 mg daily for 4 days.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Participant (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
  • Participant ≥18 years of age.
  • Documentation of confirmed active SARS-CoV-2 infection, as determined by a molecular test conducted at any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent from any respiratory specimen collected <96 hours from when the first dose of study treatment is expected to be taken.
  • Experiencing at least one of the following SARS-CoV-2 infection symptoms within 24 hours of screening: fever (can be subjective) OR cough OR shortness of breath.
  • Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period up until reaching hospitalization or 21 days, whichever is earliest.

This is a partial list of elgibility requirements.

Clinical Trial Area: 
COVID-19
Contact Email: 
Contact Phone: 
(312) 563-1345
Contact Name: 
Beverly E Sha, MD