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NCT Number: NCT04334512

A 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).

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Key information

Conditions

COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Coronavirus-19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ProgenaBiome

Ventura, California, 93003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Hydroxychloroquine

Drug

Treatment with hydroxychloroquine

Other names: Plaquenil

Azithromycin

Drug

Treatment with azithromycin

Other names: Zithromax

Vitamin C

Dietary Supplement

Treatment with vitamin C

Vitamin D

Dietary Supplement

Treatment with vitamin D

Zinc

Dietary Supplement

Treatment with Zinc

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

ProgenaBiome

Other

Collaborators

  • DSCS CRO

Registry information

Official study title

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

Acronym: HAZDpaC

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 6, 2020
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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