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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Tolerability study of HCQ 1200 mg administered daily in divided doses for a duration of 5-10 days
University of Chicago
Chicago, Illinois, United States
Tolerability of high dose HCQ as measured by HCQ dose modification and ability to complete course
Number of subjects requiring HCQ dose modifications
Time frame: 14 days
Tolerability of high dose HCQ as measured by discontinuation of HCQ before end of course
Number of subjects that discontinue HCQ
Time frame: 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
Time frame: 14 days
Rate of hospitalization due to COVID-19 as measured by number of patients hospitalized
Number of patients admitted to hospital during study period
Time frame: 14 days
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)
Time frame: 14 days
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.
Time frame: 14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.