Overview

A Study of Quintuple Therapy to Treat COVID-19 Infection

Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ProgenaBiome
Collaborator:
DSCS CRO
Treatments:
Ascorbic Acid
Azithromycin
Hydroxychloroquine
Vitamin D
Vitamins
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