Hydroxychloroquine

Generic Name: Hydroxychloroquine

Brand Names: Plaquenil, Sovuna

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₆ClN_₃O

CAS Number: 118-42-3

Unique Ingredient Identifier: 4QWG6N8QKH

Background: Hydroxychloroquine is a racemic mixture consisting of an R and S enantiomer. Hydroxychloroquine is an aminoquinoline like chloroquine. It is a commonly prescribed medication in the treatment of uncomplicated malaria, rheumatoid arthritis, chronic discoid lupus erythematosus, and systemic lupus erythematosus. Hydroxychloroquine is also used for the prophylaxis of malaria in regions where chloroquine resistance is unlikely. It was developed during World War II as a derivative of quinacrine with less severe side effects. Chloroquine and hydroxychloroquine are both being investigated for the treatment of SARS-CoV-2.

The FDA emergency use authorization for hydroxychloroquine and chloroquine in the treatment of COVID-19 was revoked on 15 June 2020.

Hydroxychloroquine was granted FDA approval on 18 April 1955.

A recent study reported a fatality in the group being treated with hydroxychloroquine for COVID-19.

Indication: Hydroxychloroquine is indicated for the prophylaxis of malaria where chloroquine resistance is not reported, treatment of uncomplicated malaria (caused by P. falciparum, P. malariae, P. ovale, or P. vivax), chronic discoid lupus erythematosus, systemic lupus erythematosus, acute rheumatoid arthritis, and chronic rheumatoid arthritis.

Associated Conditions: Acute Rheumatoid Arthritis, Malaria, Porphyria Cutanea Tarda, Q Fever, Sjogren's Syndrome (SS), Systemic Lupus Erythematosus, Uncomplicated Malaria caused by Plasmodium Vivax, Uncomplicated Malaria caused by Plasmodium malariae, Uncomplicated Malaria caused by Plasmodium ovale, Chronic Discoid Lupus Erythematosus (DLE), Chronic Rheumatoid Arthritis, Uncomplicated Malaria caused by Plasmodium falciparum

Associated Therapies: -

Clinical Trials

Efficacy and Safety of Hydroxychloroquine and Azithromycin for Patients With Moderate to Severe COVID-19

Early Phase 1

Suspended

Conditions: COVID-19

Interventions: Drug: Hydroxychloroquine Sulfate
Drug: Azithromycin Tablets

First Posted Date: 2020-04-01

Last Posted Date: 2022-11-07

Lead Sponsor: Azidus Brasil

Target Recruit Count: 400

Registration Number: NCT04329572

Locations: 🇧🇷
Prevent Senior Private Operadora de Saúde LTDA., São Paulo, Brazil

ALBERTA HOPE COVID-19 for the Prevention of Severe COVID19 Disease

Phase 3

Terminated

Conditions: COVID-19

Interventions: Drug: Hydroxychloroquine

First Posted Date: 2020-04-01

Last Posted Date: 2020-07-31

Lead Sponsor: Dr. Michael Hill

Target Recruit Count: 148

Registration Number: NCT04329611

Locations: 🇨🇦
University of Alberta, Edmonton, Alberta, Canada
🇨🇦
University of Calgary/Foothills Medical Centre, Calgary, Alberta, Canada

Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection

Phase 4

Withdrawn

Conditions: COVID 19
Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors

Interventions: Drug: Hidroxicloroquina
Drug: Control group

First Posted Date: 2020-04-01

Last Posted Date: 2021-09-16

Lead Sponsor: Instituto de Investigación Marqués de Valdecilla

Registration Number: NCT04330495

Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19

Phase 2

Completed

Conditions: COVID-19

Interventions: Drug: Hydroxychloroquine
Drug: Azithromycin

First Posted Date: 2020-04-01

Last Posted Date: 2022-04-20

Lead Sponsor: Intermountain Health Care, Inc.

Target Recruit Count: 85

Registration Number: NCT04329832

Locations: 🇺🇸
Intermountain Medical Center, Murray, Utah, United States
🇺🇸
University of Utah, Salt Lake City, Utah, United States

Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)

Phase 2

Completed

Conditions: SARS-CoV-2
SARS (Severe Acute Respiratory Syndrome)
COVID-19
Corona Virus Infection

Interventions: Drug: Ascorbic Acid
Drug: Hydroxychloroquine Sulfate

First Posted Date: 2020-04-01

Last Posted Date: 2021-12-16

Lead Sponsor: University of Washington

Target Recruit Count: 943

Registration Number: NCT04328961

Locations: 🇺🇸
University of Washington, Coordinating Center, Seattle, Washington, United States
🇺🇸
Tulane, New Orleans, Louisiana, United States
🇺🇸
University of California Los Angeles, Los Angeles, California, United States

and more 5 locations

Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers

Phase 3

Terminated

Conditions: COVID-19

Interventions: Drug: Hydroxychloroquine
Drug: Lopinavir and ritonavir
Drug: Placebo of Hydroxychloroquine
Drug: Placebo of LPV/r Tablets

First Posted Date: 2020-03-31

Last Posted Date: 2023-03-01

Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Target Recruit Count: 118

Registration Number: NCT04328285

Locations: 🇫🇷
CHU de Rouen, Rouen, France
🇫🇷
CHU de Bordeaux, Bordeaux, France
🇫🇷
CHU de Rennes, Rennes, France

and more 6 locations

Pre-exposure Prophylaxis for SARS-Coronavirus-2

Phase 3

Completed

Conditions: Corona Virus Infection
Acute Respiratory Distress Syndrome
COVID-19
ARDS

Interventions: Other: Placebo
Drug: Hydroxychloroquine

First Posted Date: 2020-03-31

Last Posted Date: 2021-07-02

Lead Sponsor: University of Minnesota

Target Recruit Count: 1483

Registration Number: NCT04328467

Locations: 🇺🇸
Nationwide Enrollment via Internet, please email: covid19@umn.edu, Minneapolis, Minnesota, United States
🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States