Coronavirus-19, Corona Virus Infection, COVID-19, Sars-CoV2
Conditions
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.
Interventions
DRUGHydroxychloroquine
Treatment with hydroxychloroquine
DRUGAzithromycin
Treatment with azithromycin
DIETARY_SUPPLEMENTVitamin C
Treatment with vitamin C
DIETARY_SUPPLEMENTVitamin D
Treatment with vitamin D
DIETARY_SUPPLEMENTZinc
Treatment with Zinc
Sponsors
DSCS CRO
ProgenaBiome
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent provided electronically via the EDC, demonstrating that the subject understands the procedures required for the study and the purpose of the study 2. Male or female subjects 18 years of age and up 3. 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) 4. Diagnosis of COVID-19 by RT-PCR
Exclusion criteria
1. Refusal to provide informed consent 2. Diarrhea prior to infection 3. Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject 4. Any contraindications for treatment with hydroxychloroquine 1. Hypoglycemia 2. Known G6PD deficiency 3. Porphyria 4. Anemia 5. Neutropenia 6. Alcoholism 7. Myasthenia gravis 8. Skeletal muscle disorders 9. Maculopathy 10. Changes in visual field 11. Liver disease 12. Psoriasis 5. Anemia from pyruvate kinase and G6PD deficiencies 6. Abnormal EKG with QT prolongation acquired or from birth 7. Allergies to 4-Aminoquinolines 8. History of jaundice or high fevers prior to developing COVID-19 9. Treatment with any of the medications listed in Appendix II 10. Treatment with any other drug not listed that affects the QT interval 11. Treatment with any anti-epileptic drug, whether prescribed for seizures or otherwise. 12. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy | 12 weeks | Number of days from COVID-19 diagnosis to recovery via RT-PCR |
| Reduction or Progression of Symptomatic Days | 12 weeks | Reduction and/or progression of symptomatic days, reduction of symptom severity |
| Assess the safety of Quintuple Therapy | 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 | 12 weeks | Pulse from baseline to 12 weeks |
| Assess the safety of Quintuple Therapy via oxygen saturation | 12 weeks | Oxygen saturation from baseline to 12 weeks |
| Assess the safety of Quintuple Therapy via EKG | 12 weeks | EKG response from baseline to 12 weeks |
| Assess Tolerability of Quintuple Therapy | 12 weeks | Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy |
Countries
United States
Outcome results
None listed