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

A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection

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).

Study Overview

• Status: Completed
• Conditions: COVID-19; Corona Virus Infection; Sars-CoV2; Coronavirus-19
• Intervention / Treatment: Drug: Hydroxychloroquine; Drug: Azithromycin; Dietary supplement: Vitamin C; Dietary supplement: Vitamin D; Dietary supplement: Zinc

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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Ventura, California, United States, 93003
      • ProgenaBiome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy	Number of days from COVID-19 diagnosis to recovery via RT-PCR	12 weeks
Reduction or Progression of Symptomatic Days	Reduction and/or progression of symptomatic days, reduction of symptom severity	12 weeks
Assess the safety of Quintuple Therapy	Assess the symptom response to study therapy as measured by the survey in the EDC	12 weeks
Assess the safety of Quintuple Therapy via pulse	Pulse from baseline to 12 weeks	12 weeks
Assess the safety of Quintuple Therapy via oxygen saturation	Oxygen saturation from baseline to 12 weeks	12 weeks
Assess the safety of Quintuple Therapy via EKG	EKG response from baseline to 12 weeks	12 weeks
Assess Tolerability of Quintuple Therapy	Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy	12 weeks

Collaborators and Investigators

• Sponsor: ProgenaBiome
• Collaborators: DSCS CRO
• Investigators: Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Publications and helpful links

General Publications

• Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
• Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.
• Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Jun;57:279-283. doi: 10.1016/j.jcrc.2020.03.005. Epub 2020 Mar 10.
• Banjanac M, Munic Kos V, Nujic K, Vrancic M, Belamaric D, Crnkovic S, Hlevnjak M, Erakovic Haber V. Anti-inflammatory mechanism of action of azithromycin in LPS-stimulated J774A.1 cells. Pharmacol Res. 2012 Oct;66(4):357-62. doi: 10.1016/j.phrs.2012.06.011. Epub 2012 Jul 3.
• Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Actual): February 27, 2024
• Study Completion (Actual): February 27, 2024

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Coronavirus Infections; Infections; Communicable Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Micronutrients; Anti-Bacterial Agents; Bone Density Conservation Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Vitamin D; Vitamins; Azithromycin; Hydroxychloroquine
• Other Study ID Numbers: PRG-044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No