A Study of Quintuple Therapy to Treat COVID-19 Infection

Purpose

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).

Conditions

  • COVID-19
  • Corona Virus Infection
  • Coronavirus-19
  • Sars-CoV2

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional Study
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Quintuple Therapy 		Patients will be treated with quintuple therapy for 10 days.
  • Drug: Hydroxychloroquine
    Treatment with hydroxychloroquine
    Other names:
    • Plaquenil
  • Drug: Azithromycin
    Treatment with azithromycin
    Other names:
    • Zithromax
  • Dietary Supplement: Vitamin C
    Treatment with vitamin C
  • Dietary Supplement: Vitamin D
    Treatment with vitamin D
  • Dietary Supplement: Zinc
    Treatment with Zinc
Placebo Comparator
Placebo 		Patients will be treated with placebo.
  • Dietary Supplement: Vitamin C
    Treatment with vitamin C
  • Dietary Supplement: Vitamin D
    Treatment with vitamin D
  • Dietary Supplement: Zinc
    Treatment with Zinc

Recruiting Locations

More Details

NCT ID
NCT04334512
Status
Completed
Sponsor
ProgenaBiome

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.