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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 22 Jul 2020

At a glance

  • Drugs Ascorbic acid (Primary) ; Azithromycin (Primary) ; Hydroxychloroquine (Primary) ; Vitamin D (Primary) ; Zinc (Primary)
  • Indications COVID 2019 infections; Respiratory tract infections
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms HAZCpaC
  • Most Recent Events

    • 27 Jun 2020 Planned End Date changed from 1 Aug 2021 to 1 Sep 2021.
    • 27 Jun 2020 Planned primary completion date changed from 1 May 2021 to 1 Jun 2021.
    • 27 Jun 2020 Status changed from not yet recruiting to recruiting.

Trial Overview

Purpose

This is a Phase II interventional study will test the efficacy and safety of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).

Primary Endpoints

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

Reduction or Progression of Symptomatic Days

description: Reduction and/or progression of symptomatic days, reduction of symptom severity
time_frame: 12 weeks

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

Assess the safety of Quintuple Therapy via pulse

description: Pulse from baseline to 12 weeks
time_frame: 12 weeks

Assess the safety of Quintuple Therapy via oxygen saturation

description: Oxygen saturation from baseline to 12 weeks
time_frame: 12 weeks

Assess the safety of Quintuple Therapy via EKG

description: EKG response from baseline to 12 weeks
time_frame: 12 weeks

Assess Tolerability of Quintuple Therapy

description: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
time_frame: 12 weeks

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Respiratory tract infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 600

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient Inclusion 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

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04334512 ClinicalTrials.gov: US National Institutes of Health
PRG044 -

Trial Dates

  • Initiation Dates

    Planned : 01 May 2020

    Actual : 22 Jun 2020

  • Primary Completion Dates

    Planned : 01 Jun 2021

  • End Dates

    Planned : 01 Sep 2021

Other Details

  • Design double-blind; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location USA
  • Focus Adverse reactions; Therapeutic Use

Interventions

Drugs Route Formulation
Ascorbic acidPrimary Drug
-
-
AzithromycinPrimary Drug
-
-
HydroxychloroquinePrimary Drug
-
-
Vitamin DPrimary Drug
-
-
ZincPrimary Drug
-
-

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

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)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Jordan Daniels, MS
217-494-6692
msjordandaniels@gmail.com
show details
-
Sabine Hazan, MD
805-200-7436
sabinehazan@aim.com
show details
ProgenaBiome USA

Centres

Centre Name Location Trial Centre Country
-
-
-
ProgenaBiome
-
-
ProgenaBiome Ventura, California USA

Trial History

Event Date Event Type Comment
22 Jul 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 22 Jul 2020
27 Jun 2020 Completion date Planned End Date changed from 1 Aug 2021 to 1 Sep 2021. Updated 01 Jul 2020
27 Jun 2020 Other trial event Planned primary completion date changed from 1 May 2021 to 1 Jun 2021. Updated 01 Jul 2020
27 Jun 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 01 Jul 2020
08 May 2020 Completion date Planned End Date changed from 1 Jul 2021 to 1 Aug 2021. Updated 13 May 2020
08 May 2020 Other trial event Planned primary completion date changed from 1 Apr 2021 to 1 May 2021. Updated 13 May 2020
08 May 2020 Other trial event Planned initiation date changed from 1 Apr 2020 to 1 May 2020. Updated 13 May 2020
09 Apr 2020 Other trial event Planned number of patients changed from 60 to 600. Updated 14 Apr 2020
08 Apr 2020 New trial record New trial record Updated 08 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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