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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring hydroxychloroquine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydroxychloroquine

Arm Description

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.

Outcomes

Primary Outcome Measures

Tolerability of high dose HCQ as measured by HCQ dose modification and ability to complete course
Number of subjects requiring HCQ dose modifications
Tolerability of high dose HCQ as measured by discontinuation of HCQ before end of course
Number of subjects that discontinue HCQ
Tolerability of High Dose HCQ as measured by Adverse Events
Number of Adverse Events observed in all subjects for the duration of the study

Secondary Outcome Measures

Rate of hospitalization due to COVID-19 as measured by number of patients hospitalized
Number of patients admitted to hospital during study period
Time to defervescence as measured in days while on treatment protocol
The number of days to reach first fever normalization (criteria for normalization: temperature < 100.4 F)
Resolution of other COVID-19 symptoms measured in days while on treatment protocol
Number of days to resolve other symptoms, as assessed by a standardized questionnaire for symptom assessment.

Full Information

First Posted
April 14, 2020
Last Updated
February 21, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04351620
Brief Title
High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19
Official Title
High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
June 10, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

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

5. Study Description

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.
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. The 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 investigator 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
hydroxychloroquine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Tolerability study of HCQ 1200 mg administered daily in divided doses for a duration of 5-10 days
Primary Outcome Measure Information:
Title
Tolerability of high dose HCQ as measured by HCQ dose modification and ability to complete course
Description
Number of subjects requiring HCQ dose modifications
Time Frame
14 days
Title
Tolerability of high dose HCQ as measured by discontinuation of HCQ before end of course
Description
Number of subjects that discontinue HCQ
Time Frame
14 days
Title
Tolerability of High Dose HCQ as measured by Adverse Events
Description
Number of Adverse Events observed in all subjects for the duration of the study
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Rate of hospitalization due to COVID-19 as measured by number of patients hospitalized
Description
Number of patients admitted to hospital during study period
Time Frame
14 days
Title
Time to defervescence as measured in days while on treatment protocol
Description
The number of days to reach first fever normalization (criteria for normalization: temperature < 100.4 F)
Time Frame
14 days
Title
Resolution of other COVID-19 symptoms measured in days while on treatment protocol
Description
Number of days to resolve other symptoms, as assessed by a standardized questionnaire for symptom assessment.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reem Jan
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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