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

Primary Purpose

COVID-19, Corona Virus Infection, Coronavirus-19

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Azithromycin
Vitamin C
Vitamin D
Zinc
Sponsored by
ProgenaBiome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  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

Sites / Locations

  • ProgenaBiomeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Quintuple Therapy

Placebo

Arm Description

Patients will be treated with quintuple therapy for 10 days.

Patients will be treated with placebo.

Outcomes

Primary Outcome Measures

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
Reduction or Progression of Symptomatic Days
Reduction and/or progression of symptomatic days, reduction of symptom severity
Assess the safety of Quintuple Therapy
Assess the symptom response to study therapy as measured by the survey in the EDC
Assess the safety of Quintuple Therapy via pulse
Pulse from baseline to 12 weeks
Assess the safety of Quintuple Therapy via oxygen saturation
Oxygen saturation from baseline to 12 weeks
Assess the safety of Quintuple Therapy via EKG
EKG response from baseline to 12 weeks
Assess Tolerability of Quintuple Therapy
Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy

Secondary Outcome Measures

Full Information

First Posted
April 2, 2020
Last Updated
September 2, 2021
Sponsor
ProgenaBiome
Collaborators
DSCS CRO
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1. Study Identification

Unique Protocol Identification Number
NCT04334512
Brief Title
A Study of Quintuple Therapy to Treat COVID-19 Infection
Acronym
HAZDpaC
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProgenaBiome
Collaborators
DSCS CRO

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Corona Virus Infection, Coronavirus-19, Sars-CoV2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional Study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quintuple Therapy
Arm Type
Experimental
Arm Description
Patients will be treated with quintuple therapy for 10 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will be treated with placebo.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Plaquenil
Intervention Description
Treatment with hydroxychloroquine
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Zithromax
Intervention Description
Treatment with azithromycin
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Intervention Description
Treatment with vitamin C
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Treatment with vitamin D
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Intervention Description
Treatment with Zinc
Primary Outcome Measure Information:
Title
The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy
Description
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Time Frame
12 weeks
Title
Reduction or Progression of Symptomatic Days
Description
Reduction and/or progression of symptomatic days, reduction of symptom severity
Time Frame
12 weeks
Title
Assess the safety of Quintuple Therapy
Description
Assess the symptom response to study therapy as measured by the survey in the EDC
Time Frame
12 weeks
Title
Assess the safety of Quintuple Therapy via pulse
Description
Pulse from baseline to 12 weeks
Time Frame
12 weeks
Title
Assess the safety of Quintuple Therapy via oxygen saturation
Description
Oxygen saturation from baseline to 12 weeks
Time Frame
12 weeks
Title
Assess the safety of Quintuple Therapy via EKG
Description
EKG response from baseline to 12 weeks
Time Frame
12 weeks
Title
Assess Tolerability of Quintuple Therapy
Description
Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Informed consent provided electronically via the EDC, demonstrating that the subject understands the procedures required for the study and the purpose of the study Male or female subjects 18 years of age and up 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) Diagnosis of COVID-19 by RT-PCR Exclusion Criteria Refusal to provide informed consent Diarrhea prior to infection Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject Any contraindications for treatment with hydroxychloroquine Hypoglycemia Known G6PD deficiency Porphyria Anemia Neutropenia Alcoholism Myasthenia gravis Skeletal muscle disorders Maculopathy Changes in visual field Liver disease Psoriasis Anemia from pyruvate kinase and G6PD deficiencies Abnormal EKG with QT prolongation acquired or from birth Allergies to 4-Aminoquinolines History of jaundice or high fevers prior to developing COVID-19 Treatment with any of the medications listed in Appendix II Treatment with any other drug not listed that affects the QT interval Treatment with any anti-epileptic drug, whether prescribed for seizures or otherwise. Pregnant or breastfeeding women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Hazan, MD
Phone
805-339-0549
Email
drsabinehazan@progenabiome.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Daniels, MS
Phone
217-494-6692
Email
jordan@progenabiome.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, MD
Organizational Affiliation
ProgenaBiome
Official's Role
Principal Investigator
Facility Information:
Facility Name
ProgenaBiome
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, MD
Phone
805-339-0549
Email
drsabinehazan@progenabiome.com
First Name & Middle Initial & Last Name & Degree
Jordan Daniels, MS
Phone
805-339-0549
Email
jordan@progenabiome.com
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22766077
Citation
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.
Results Reference
background
PubMed Identifier
32173110
Citation
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.
Results Reference
background
PubMed Identifier
32074550
Citation
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.
Results Reference
background
PubMed Identifier
32205204
Citation
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.
Results Reference
background
PubMed Identifier
32052466
Citation
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.
Results Reference
background

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A Study of Quintuple Therapy to Treat COVID-19 Infection

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