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High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04351620
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
This study aims to examine the tolerability of high dose hydroxychloroquine in patients with COVID-19 who are not yet hospitalized, but have risk factors for disease progression and complications.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Phase 1

Detailed Description:

This is a single arm and single-center tolerability study of high dose HCQ therapy in outpatient adult participants with mild COVID-19. In vitro studies have shown antiviral effects of HCQ against SARS Cov-2, but the clinical outcomes in the disease have been variable. Our hypothesis is that targeting high risk patients earlier in the disease course and with a higher dose regimen are both required to see improvement in disease outcome measures in COVID-19. This study aims to prove the tolerability of high dose HCQ in this setting.

Patients are selected based on the identification of risk factors associated with more severe disease outcomes. Investigators will enroll twenty patients and perform a detailed Tele-health interview to ensure they meet eligibility criteria and provide informed consent. 1200 mg hydroxychloroquine daily will be prescribed, in divided doses.The subjects will be required to monitor their temperatures twice daily and a daily telephone call with an investigatory will review symptoms of disease and potential side effects of the drug. Subjects can discontinue the medication after five days if they no longer have fever, or take the medication for up to ten days if required for fever resolution.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Hydroxychloroquine

Hydroxychloroquine 1200 mg daily administered as 600 mg BID for five days or until fevers abate (maximum ten days of treatment allowed).

If patients report gastrointestinal discomfort, the dose will be administered as 400 mg TID.

Drug: Hydroxychloroquine
Tolerability study of HCQ 1200 mg administered daily in divided doses for a duration of 5-10 days

Primary Outcome Measures :
  1. Tolerability of high dose HCQ as measured by HCQ dose modification [ Time Frame: 14 days ]
    Number of subjects requiring HCQ dose modifications

  2. Tolerability of high dose HCQ as measured by discontinuation of HCQ [ Time Frame: 14 days ]
    Number of subjects that discontinue HCQ

  3. Tolerability of High Dose HCQ as measured by Adverse Events [ Time Frame: 14 days ]
    Number of Adverse Events observed in all subjects for the duration of the study

Secondary Outcome Measures :
  1. Rate of hospitalization due to COVID-19 as measured by number of patients hospitalized [ Time Frame: 14 days ]
    Number of patients admitted to hospital during study period

  2. Time to defervescence as measured in days while on treatment protocol [ Time Frame: 14 days ]
    The number of days to reach first fever normalization (criteria for normalization: temperature < 100.4 F)

  3. Resolution of other COVID-19 symptoms measured in days while on treatment protocol [ Time Frame: 14 days ]
    Number of days to resolve other symptoms, as assessed by a standardized questionnaire for symptom assessment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Being tested positive for SARS-Cov-2 in outpatient setting in drive-thru, ED, or ambulatory clinics at the University of Chicago within 72 hours of enrollment.
  • Age >18
  • Fever >100.4 F by any conventional clinical method (forehead, tympanic, oral, axillary, rectal) within 48h prior to enrollment
  • Mild COVID-19, defined as the presence of any symptom consistent with an upper respiratory tract infection, including dry cough, sore throat, nasal congestion, fatigue, myalgia, headaches.

Subjects must meet all the above-mentioned criteria, in addition to at least one of the following criteria:

  • Age > 55
  • Pre-existing pulmonary disease: airway diseases (asthma, chronic obstructive pulmonary disease, bronchiectasis, cystic fibrosis), history of active or treated lung cancer, history of pneumectomy, interstitial lung diseases, pulmonary hypertension, sleep apnea.
  • Diabetes: uncontrolled or controlled diabetes
  • Hypertension
  • Chronic kidney disease stage 1-3
  • History of cardiovascular disease with an electrocardiogram available to the physician-investigator through the subject's electronical medical record within the past thirty days showing a normal QT interval (QT < 500 ms).
  • History of immunosuppression
  • Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
  • At least one fever every 24 hours for > 72h

Exclusion Criteria:

  • Participation in any other clinical trial of an experimental agent treatment for COVID-19
  • Current hospitalization
  • Known hypersensitivity to hydroxyxhloroquine or chloroquine
  • Known chronic kidney disease, stage 4-5, or receiving dialysis
  • History of retinal disease
  • History of uncontrolled hypertension, defined as systolic blood pressure > 180 mmHg and or diastolic blood pressure > 100 mmHg at the most recent physical medical encounter or by patient report.
  • History of QT prolongation (QT > 500 ms) or history of Torsades de Pointes
  • History of arrhythmias
  • Current use of loop diuretics and potassium supplementation or documented history of hypokalemia.
  • Pregnancy and lactation
  • Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Current use of any of the following medications: flecainide (Tambocor), amiodarone (Cordarone, Pacerone), digoxin (Digox, Digitek), procainamide (Procan, Procanbid), propafenone (Rythmal), antiepileptic agents (phenytoin, phenobarbital, valproic acid, lamotrigine, topiramate), tamoxifen, tricyclic antidepressants (nortriptyline, amitriptyline, imipramine, clomipramine)
  • Inability to monitor body temperature (oral, axillary, tympanic or frontal) at least twice a day from study enrollment day (Day 1) to the end of the study (Day 14).
  • Inability to provide informed consent to the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04351620

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Contact: Reem Jan, MBBS BSc 734-972-7953
Contact: Iazsmin Ventura, MD

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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Reem Jan    734-972-7953   
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Reem Jan University of Chicago
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Responsible Party: University of Chicago Identifier: NCT04351620    
Other Study ID Numbers: IRB20-0572
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Chicago:
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents