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A Study of Quintuple Therapy to Treat COVID-19 Infection

A Study of Quintuple Therapy to Treat COVID-19 Infection

Non Recruiting
18 years and older
All
Phase 2

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Overview

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).

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.

Eligibility

  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 details
    COVID-19
    Corona Virus Infection
    Coronavirus-19
    Sars-CoV2

NCT04334512

ProgenaBiome

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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