Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Clara Health

Combination Azithromycin and Hydroxychloroquine for the Treatment of COVID-19

Sponsored by Rutgers, The State University of New Jersey

This is a three-arm randomized trial comparing the efficacy of single agent hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a delayed hydroxychloroquine regimen, which will serve as a contemporaneous Day 1-6 supportive care control, in eliminating detectable SARS-CoV-2 on day 6 following the initiation of treatment in order to determine which regimen is more effective.


Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.

How is this study designed?

Study Type: Interventional (Clinical Trial) Estimated Enrollment: 160 participants Primary Purpose: Treatment Actual Study Start Date: April 1, 2020 Estimated Study Completion Date: April 30, 2021

Who is this study for?

Inclusion Criteria*:

  • Patients with proven SARS-CoV-2 infection by an accepted assay with symptoms consistent with COVID-19
  • Temperature >100.6°F
  • Age 18 to 89
  • Ability to swallow oral medications

Exclusion Criteria*:

  • Pregnancy or women who are breast feeding
  • Patients that lack decision-making capacity will not be approached to participate in this study

* Additional criteria apply. Please speak with the study team for further information.

What should I expect?

Experimental: Arm 1: Hydroxychloroquine Sulfate + Azithromycin

  • Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
  • Azithromycin 500 mg taken by mouth on Day 1, followed by
  • Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.

Experimental: Arm 2: Hydroxychloroquine Sulfate alone

  • Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days

No Intervention: Arm 3: Supportive Care

  • Supportive care Days 1-6.
  • If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days

Connect with the study team

Thank you for your interest in advancing COVID-19 research.

To learn more about this study, please fill out the interest form to be connected to a member of the study team. The following contact information that you enter into this form will only be shared with the research team conducting this specific study.

If you have any difficulties or questions, please contact our support specialists at [email protected]

Have questions or need help?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.