High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19
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|ClinicalTrials.gov Identifier: NCT04351620|
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Hydroxychloroquine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Tolerability study of HCQ 1200 mg administered daily in divided doses for a duration of 5-10 days
- Tolerability of high dose HCQ as measured by HCQ dose modification [ Time Frame: 14 days ]Number of subjects requiring HCQ dose modifications
- Tolerability of high dose HCQ as measured by discontinuation of HCQ [ Time Frame: 14 days ]Number of subjects that discontinue HCQ
- 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
- 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
- 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)
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04351620
|Contact: Reem Jan, MBBS BScfirstname.lastname@example.org|
|Contact: Iazsmin Ventura, MDemail@example.com|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Reem Jan 734-972-7953 firstname.lastname@example.org|
|Principal Investigator:||Reem Jan||University of Chicago|