A Study of Quintuple Therapy to Treat COVID-19 Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection

Conditions
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COVID-19, Corona Virus Infection, Coronavirus-19, Sars-CoV2

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: Azithromycin
* Dietary Supplement: Vitamin C
* Dietary Supplement: Vitamin D
* Dietary Supplement: Zinc


Participation Criteria
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Eligibility Criteria
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Informed consent provided electronically via the EDC, demonstrating that the subject understands the procedures required for the study and the purpose of the study Male or female subjects 18 years of age and up Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized) Diagnosis of COVID-19 by RT-PCR Exclusion Criteria Refusal to provide informed consent Diarrhea prior to infection Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject Any contraindications for treatment with hydroxychloroquine Hypoglycemia Known G6PD deficiency Porphyria Anemia Neutropenia Alcoholism Myasthenia gravis Skeletal muscle disorders Maculopathy Changes in visual field Liver disease Psoriasis Anemia from pyruvate kinase and G6PD deficiencies Abnormal EKG with QT prolongation acquired or from birth Allergies to 4-Aminoquinolines History of jaundice or high fevers prior to developing COVID-19 Treatment with any of the medications listed in Appendix II Treatment with any other drug not listed that affects the QT interval Treatment with any anti-epileptic drug, whether prescribed for seizures or otherwise. Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quintuple Therapy<br>Patients will be treated with quintuple therapy for 10 days. | Drug: Hydroxychloroquine<br>* Treatment with hydroxychloroquine<br>* Other names: Plaquenil;Drug: Azithromycin<br>* Treatment with azithromycin<br>* Other names: Zithromax;Dietary Supplement: Vitamin C<br>* Treatment with vitamin C<br>Dietary Supplement: Vitamin D<br>* Treatment with vitamin D<br>Dietary Supplement: Zinc<br>* Treatment with Zinc<br>|
| Placebo Comparator: Placebo<br>Patients will be treated with placebo. | Dietary Supplement: Vitamin C<br>* Treatment with vitamin C<br>Dietary Supplement: Vitamin D<br>* Treatment with vitamin D<br>Dietary Supplement: Zinc<br>* Treatment with Zinc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 
| Reduction or Progression of Symptomatic Days | Reduction and/or progression of symptomatic days, reduction of symptom severity | 12 weeks | 
| Assess the safety of Quintuple Therapy | Assess the symptom response to study therapy as measured by the survey in the EDC | 12 weeks | 
| Assess the safety of Quintuple Therapy via pulse | Pulse from baseline to 12 weeks | 12 weeks | 
| Assess the safety of Quintuple Therapy via oxygen saturation | Oxygen saturation from baseline to 12 weeks | 12 weeks | 
| Assess the safety of Quintuple Therapy via EKG | EKG response from baseline to 12 weeks | 12 weeks | 
| Assess Tolerability of Quintuple Therapy | Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy | 12 weeks |