NCT04458948

Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients

Open Label Non-comparative Trial of the Combination of Hydroxychloroquine and Azithromycin in the Treatment of Hospitalized Patients With Moderate or Severe COVID-19 Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is designed as an open-label,non-comparative prospective trial.

Detailed description

The objects of this research are as follows: (1) To measure the duration of viral shedding in respiratory secretions of patients with moderate or severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin. (2) Evaluate the case fatality rate, the clinical response and length of stay in hospitalized patients with moderate and severe COVID-19 infection. (3) To report the safety of the drug combination in hospitalized patients with moderate and severe COVID-19 infection.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Hydroxychloroquine 400 mg BID, on day 1 and then 200 mg BID day 2 through 7 IV or po for 5 days. If the condition of the patient does not allow for oral therapy, HCQ can be given via a feeding or NG tube. Azithromycin can be given intravenously.
DRUG	Azithromycin	Azithromycin 500 mg, IV or po for 5 days

Timeline

• Start date: 2020-03-24
• Primary completion: 2020-08-28
• Completion: 2020-08-28
• First posted: 2020-07-07
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study