Trials / Completed
CompletedNCT04351620
High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hydroxychloroquine | Tolerability study of HCQ 1200 mg administered daily in divided doses for a duration of 5-10 days |
Timeline
- Start date
- 2020-04-20
- Primary completion
- 2020-06-10
- Completion
- 2020-06-10
- First posted
- 2020-04-17
- Last updated
- 2023-02-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04351620. Inclusion in this directory is not an endorsement.