A Study of Quintuple Therapy to Treat COVID-19 Infection (HAZDpaC)

ProgenaBiome

Status and phase: Completed; Phase 2

Conditions: Sars-CoV2; COVID-19; Corona Virus Infection; Coronavirus-19

Treatments: Dietary Supplement: Zinc; Dietary Supplement: Vitamin D; Drug: Hydroxychloroquine; Drug: Azithromycin; Dietary Supplement: Vitamin C

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04334512

PRG-044

Details and patient eligibility

About

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).

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 2 patient groups, including a placebo group

Quintuple Therapy

Experimental group

Description:

Patients will be treated with quintuple therapy for 10 days.

Treatment:

Dietary Supplement: Vitamin C

Drug: Azithromycin

Drug: Hydroxychloroquine

Dietary Supplement: Zinc

Dietary Supplement: Vitamin D

Placebo

Placebo Comparator group

Description:

Patients will be treated with placebo.

Treatment:

Dietary Supplement: Vitamin C

Dietary Supplement: Zinc

Dietary Supplement: Vitamin D