Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease (ORCHID)
Clara Health

Outcomes Related to COVID-19 Treated With Hydroxychloroquine (ORCHID)

Sponsored by Massachusetts General Hospital


Effective therapies for COVID-19 are urgently needed. Hydroxychloroquine is an antimicrobial agent with immunomodulatory and antiviral properties that has demonstrated in vitro activity against SARS-CoV-2, the virus that causes COVID-19.

Preliminary reports suggest potential efficacy in small human studies. Clinical trial data are needed to determine whether hydroxychloroquine is effective in treating COVID-19.

About 
COVID-19

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: 510 participants Primary Purpose: Treatment Official Title: Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease (ORCHID) Actual Study Start Date: April 2, 2020 Estimated Study Completion Date: July 2021

Who is this study for?

Inclusion Criteria*:

  • Age ≥18 years
  • Currently hospitalized or in an emergency department with anticipated hospitalization.
  • Symptoms of acute respiratory infection, defined as one or more of the following:
    • cough
    • fever (> 37.5° C / 99.5° F)
    • shortness of breath
    • sore throat
  • Laboratory-confirmed SARS-CoV-2 infection within the past 10 days or SARS-CoV-2 laboratory test result pending plus a high clinical suspicion for COVID-19 as indicated by fulfilling all of the following:
    • Cough with duration ≤10 days
    • No alternative explanation for symptoms of acute respiratory infection

Exclusion Criteria*:

  • Pregnancy.
  • Symptoms of acute respiratory infection for >10 days before randomization

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

What should I expect?

Arm 1: Hydroxychlorquine Participants assigned to the hydroxychloroquine arm will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.

Hydroxychloroquine is available in 200 mg oral tablets of hydroxychloroquine sulfate.

For this COVID-19 trial, we will use an oral or enteral dose of hydroxychloroquine 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.

Arm 2: Placebo Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding.

Inpatient trial

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.