A Phase 2 interventional study of Hydroxychloroquine and Azithromycin in COVID-19, Corona Virus Infection and Coronavirus-19, sponsored by ProgenaBiome. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by ProgenaBiome · Phase 2, Interventional, and Treatment
This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).
In this study patients will be treated with a combination therapy to determine if this combination can effectively treat COVID-19. Treatment will last ten days. The study will last 24 weeks.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 118 is close to the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →ProgenaBiome is the lead sponsor of 47 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Any contraindications for treatment with hydroxychloroquine
Patients will be treated with quintuple therapy for 10 days.
Drug: Hydroxychloroquine · Drug: Azithromycin · Dietary Supplement: Vitamin C · Dietary Supplement: Vitamin D · Dietary Supplement: Zinc
Patients will be treated with placebo.
Dietary Supplement: Vitamin C · Dietary Supplement: Vitamin D · Dietary Supplement: Zinc
Treatment with hydroxychloroquine
Also known as: Plaquenil
Treatment with azithromycin
Also known as: Zithromax
Treatment with vitamin C
Treatment with vitamin D
Treatment with Zinc
The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Time frame: 12 weeks
Reduction or Progression of Symptomatic Days
Reduction and/or progression of symptomatic days, reduction of symptom severity
Time frame: 12 weeks
Assess the safety of Quintuple Therapy
Assess the symptom response to study therapy as measured by the survey in the EDC
Time frame: 12 weeks
Assess the safety of Quintuple Therapy via pulse
Pulse from baseline to 12 weeks
Time frame: 12 weeks
Assess the safety of Quintuple Therapy via oxygen saturation
Oxygen saturation from baseline to 12 weeks
Time frame: 12 weeks
Assess the safety of Quintuple Therapy via EKG
EKG response from baseline to 12 weeks
Time frame: 12 weeks
Assess Tolerability of Quintuple Therapy
Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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ProgenaBiome