A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection
Overview
- Phase
- Phase 2
- Intervention
- Hydroxychloroquine
- Conditions
- COVID-19
- Sponsor
- ProgenaBiome
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
Intervention: Hydroxychloroquine
Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
Intervention: Azithromycin
Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
Intervention: Vitamin C
Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
Intervention: Vitamin D
Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
Intervention: Zinc
Placebo
Patients will be treated with placebo.
Intervention: Vitamin C
Placebo
Patients will be treated with placebo.
Intervention: Vitamin D
Placebo
Patients will be treated with placebo.
Intervention: Zinc
Outcomes
Primary Outcomes
The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy
Time Frame: 12 weeks
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Reduction or Progression of Symptomatic Days
Time Frame: 12 weeks
Reduction and/or progression of symptomatic days, reduction of symptom severity
Assess the safety of Quintuple Therapy
Time Frame: 12 weeks
Assess the symptom response to study therapy as measured by the survey in the EDC
Assess the safety of Quintuple Therapy via pulse
Time Frame: 12 weeks
Pulse from baseline to 12 weeks
Assess the safety of Quintuple Therapy via oxygen saturation
Time Frame: 12 weeks
Oxygen saturation from baseline to 12 weeks
Assess the safety of Quintuple Therapy via EKG
Time Frame: 12 weeks
EKG response from baseline to 12 weeks
Assess Tolerability of Quintuple Therapy
Time Frame: 12 weeks
Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy