NCT04370782

Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting

A Randomized Study Evaluating the Safety and Efficacy of Hydroxychloroquine and Zinc in Combination With Either Azithromycin or Doxycycline for the Treatment of COVID-19 in the Outpatient Setting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: St. Francis Hospital, New York · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label trial to assess the safety and efficacy of hydroxychloroquine, and zinc in combination with either azithromycin or doxycycline in a higher risk COVID-19 positive outpatient population.

Detailed description

COVID-19 is an aggressive and contagious virus, found to have high mortality especially in persons with comorbidities (Age\>60, hypertension \[HTN\], diabetes mellitus \[DM\], Cancer, and otherwise immunocompromised). Zinc is a supplement with possible antiviral properties, having been shown to have effect in the common cold, many of which are due to coronavirus. In addition, elderly patients and patients with co-morbidities have high incidence of zinc deficiency. We are repleting zinc in all patients and studying its direct effect in combination with hydroxychloroquine, and an antibiotic, either azithromycin or doxycycline to see if there is enhanced treatment efficacy in early COVID-19 infection and assess the safety of these two regimen.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Hydroxychloroquine 400mg twice a day (BID) on day 1, followed by 200mg BID for days 2-5
DRUG	Azithromycin	Azithromycin 500mg on day 1, followed by 250mg once daily for days 2-5
DRUG	Zinc Sulfate	Zinc sulfate 220mg once daily for 5 days
DRUG	Doxycycline	Doxycycline 200 mg once daily for 5 days

Timeline

• Start date: 2020-04-28
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2020-05-01
• Last updated: 2020-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study