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

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ClinicalTrials.gov Identifier: NCT04334512
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : June 9, 2021
Sponsor:
Collaborator:
DSCS CRO
Information provided by (Responsible Party):
ProgenaBiome

Tracking Information
First Submitted Date  ICMJE April 2, 2020
First Posted Date  ICMJE April 6, 2020
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE June 22, 2020
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2020)
  • 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
  • Reduction or Progression of Symptomatic Days [ Time Frame: 12 weeks ]
    Reduction and/or progression of symptomatic days, reduction of symptom severity
  • 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
  • Assess the safety of Quintuple Therapy via pulse [ Time Frame: 12 weeks ]
    Pulse from baseline to 12 weeks
  • Assess the safety of Quintuple Therapy via oxygen saturation [ Time Frame: 12 weeks ]
    Oxygen saturation from baseline to 12 weeks
  • Assess the safety of Quintuple Therapy via EKG [ Time Frame: 12 weeks ]
    EKG response from baseline to 12 weeks
  • Assess Tolerability of Quintuple Therapy [ Time Frame: 12 weeks ]
    Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
  • Successful treatment as determined by Negative Test and resolution of symptoms [ Time Frame: 24 weeks ]
    Patients will experience complete resolution of symptoms and test negative for COVID-19
  • Safety of Quintuple Therapy [ Time Frame: 24 weeks ]
    Patients will tolerate Quintuple Therapy with minimal side effects. Meaning that side effects will not be severe enough to warrant discontinuation of therapy
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Quintuple Therapy to Treat COVID-19 Infection
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • COVID-19
  • Corona Virus Infection
  • Coronavirus-19
  • Sars-CoV2
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Quintuple Therapy
    Patients will be treated with quintuple therapy for 10 days.
    Interventions:
    • Drug: Hydroxychloroquine
    • Drug: Azithromycin
    • Dietary Supplement: Vitamin C
    • Dietary Supplement: Vitamin D
    • Dietary Supplement: Zinc
  • Placebo Comparator: Placebo
    Patients will be treated with placebo.
    Interventions:
    • Dietary Supplement: Vitamin C
    • Dietary Supplement: Vitamin D
    • Dietary Supplement: Zinc
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
600
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2020)
60
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sabine Hazan, MD 805-339-0549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 217-494-6692 jordan@progenabiome.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04334512
Other Study ID Numbers  ICMJE PRG-044
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ProgenaBiome
Study Sponsor  ICMJE ProgenaBiome
Collaborators  ICMJE DSCS CRO
Investigators  ICMJE
Principal Investigator: Sabine Hazan, MD ProgenaBiome
PRS Account ProgenaBiome
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP