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

NCT04351620 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB20-0572
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

hydroxychloroquine

Outcome Measures

Primary Outcomes (3)

• Tolerability of high dose HCQ as measured by HCQ dose modification and ability to complete course

  Number of subjects requiring HCQ dose modifications

  14 days

• Tolerability of high dose HCQ as measured by discontinuation of HCQ before end of course

  Number of subjects that discontinue HCQ

  14 days

• Tolerability of High Dose HCQ as measured by Adverse Events

  Number of Adverse Events observed in all subjects for the duration of the study

  14 days

Secondary Outcomes (3)

• Rate of hospitalization due to COVID-19 as measured by number of patients hospitalized

  14 days

• Time to defervescence as measured in days while on treatment protocol

  14 days

• Resolution of other COVID-19 symptoms measured in days while on treatment protocol

  14 days

Study Arms (1)

Hydroxychloroquine

EXPERIMENTAL

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

Interventions

Hydroxychloroquine DRUG

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

Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Reem Jan

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: April 20, 2020
• Primary Completion: June 10, 2020
• Study Completion: June 10, 2020
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

US (1)