A Phase II Study of Hydroxycholoroquine versus Placebo to Treat People with COVID-19 Infection

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Full Title

Single-Center, Phase II, Randomized Double-Blind, Placebo-Controlled Study of Hydroxychloroquine Compared to Placebo as Treatment for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2) Infection (COVID)

Purpose

The purpose of this study is to see if the drug hydroxychloroquine is effective for reducing the severity of symptoms in people with COVID-19 infection. Researchers think hydroxychloroquine may make the infection less severe by affecting both the virus and the immune system’s response to the virus.

Patients in this study will be randomly assigned to receive hydroxychloroquine or a placebo (inactive pill). Hydroxychloroquine is given orally (by mouth). The U.S. Food and Drug Administration has approved hydroxychloroquine for the prevention and treatment of malaria, lupus, and rheumatoid arthritis; its use in this study is considered investigational.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be hospitalized for COVID-19 infection but not be on a ventilator.
  • Patients taking medication for an irregular heart rhythm (“anti-arrhythmic drug”) may not participate.
  • This study is for patients age 18 and older.

For more information about this study, please contact Dr. Genovefa Papanicolaou at 212-639-8361.

Protocol

20-187

Phase

II

Investigator

Co-Investigators