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.
Drug: Hydroxychloroquine
Treatment with hydroxychloroquine
Other Name: Plaquenil
Drug: Azithromycin
Treatment with azithromycin
Other Name: Zithromax
Dietary Supplement: Vitamin C
Treatment with vitamin C
Dietary Supplement: Vitamin D
Treatment with vitamin D
Dietary Supplement: Zinc
Treatment with Zinc
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
ProgenaBiome
Ventura, California, United States
Investigator: Sabine Hazan, MD
Contact: 805-339-0549
drsabinehazan@progenabiome.com
Investigator: Sabine Hazan, MD
Sabine Hazan, MD
805-339-0549
drsabinehazan@progenabiome.com
Jordan Daniels, MS
217-494-6692
jordan@progenabiome.com
Sabine Hazan, MD, Principal Investigator
ProgenaBiome