A Phase 3 interventional study of Hydroxychloroquine and Azithromycin in COVID-19, sponsored by LCMC Health. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-01-21.
Sponsored by LCMC Health · Phase 3, Interventional, and Treatment
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.
This is a phase 3 study.
Primary Objective:
Secondary Objectives:
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 22 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →LCMC Health is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Supportive Care only
Hydroxychloroquine 400 mg po bid on Day 1 Hydroxychloroquine 200 mg po bid Days 2 through 5
Drug: Hydroxychloroquine
Hydroxychloroquine as in Arm B AND Azithromycin 500 mg po on Day 1 Azithromycin 250 mg po days 2 through 5
Drug: Hydroxychloroquine · Drug: Azithromycin
tablets provided as described in Arm B
tablets provided as described in Arm C
Most severe outcome
ordinal outcome of most severe a patient experienced after inpatient admission
Time frame: 5 days
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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