NCT04344444

Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease

Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: LCMC Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin.

Detailed description

This is a phase 3 study. Primary Objective: • To evaluate clinical outcomes in patients with suspected or confirmed COVID-19 with early moderate to severe disease in a randomized controlled trial. Secondary Objectives: * To evaluate quantitative viral load over time * To evaluate length of hospital stay and days in ICU * To evaluate toxicity of the treatment options * To evaluate rate of readmission after hospital discharge * To evaluate duration of clinical symptoms Arm A: Control Arm - Supportive Care Only Arm B: Hydroxychloroquine 400 mg po bid on Day 1 Hydroxychloroquine 200 mg po bid Days 2 through 5 Arm C: Hydroxychloroquine as in Arm B AND Azithromycin 500 mg po on Day 1 Azithromycin 250 mg po days 2 through 5

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	tablets provided as described in Arm B
DRUG	Azithromycin	tablets provided as described in Arm C

Timeline

• Start date: 2020-04-13
• Primary completion: 2021-04-10
• Completion: 2022-01-05
• First posted: 2020-04-14
• Last updated: 2022-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study