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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334512
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : September 5, 2021
Sponsor:
Collaborator:
DSCS CRO
Information provided by (Responsible Party):
ProgenaBiome

Study Description
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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).

Condition or disease Intervention/treatment Phase
COVID-19 Corona Virus Infection Coronavirus-19 Sars-CoV2 Drug: Hydroxychloroquine Drug: Azithromycin Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional Study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
 Drug: Hydroxychloroquine
Treatment with hydroxychloroquine
Other Name: Plaquenil

Drug: Azithromycin
Treatment with azithromycin
Other Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy [ Time Frame: 12 weeks ]
    Number of days from COVID-19 diagnosis to recovery via RT-PCR

  2. Reduction or Progression of Symptomatic Days [ Time Frame: 12 weeks ]
    Reduction and/or progression of symptomatic days, reduction of symptom severity

  3. Assess the safety of Quintuple Therapy [ Time Frame: 12 weeks ]
    Assess the symptom response to study therapy as measured by the survey in the EDC

  4. Assess the safety of Quintuple Therapy via pulse [ Time Frame: 12 weeks ]
    Pulse from baseline to 12 weeks

  5. Assess the safety of Quintuple Therapy via oxygen saturation [ Time Frame: 12 weeks ]
    Oxygen saturation from baseline to 12 weeks

  6. Assess the safety of Quintuple Therapy via EKG [ Time Frame: 12 weeks ]
    EKG response from baseline to 12 weeks

  7. Assess Tolerability of Quintuple Therapy [ Time Frame: 12 weeks ]
    Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334512


Contacts
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Contact: Sabine Hazan, MD 805-339-0549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 217-494-6692 jordan@progenabiome.com

Locations
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United States, California
ProgenaBiome Recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    drsabinehazan@progenabiome.com   
Contact: Jordan Daniels, MS    805-339-0549    jordan@progenabiome.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
ProgenaBiome
DSCS CRO
Investigators
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Principal Investigator: Sabine Hazan, MD ProgenaBiome
More Information
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Publications:

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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04334512    
Other Study ID Numbers: PRG-044
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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