A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection
Latest Information Update: 04 Mar 2024
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
- 27 Feb 2024 Status changed from recruiting to completed.
- 08 Jun 2021 Planned End Date changed from 1 Sep 2021 to 1 Sep 2024.
- 08 Jun 2021 Planned primary completion date changed from 1 Jun 2021 to 1 Jun 2023.
Most Recent Events
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 |
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COVID 2019 infections | treatment | - |
Respiratory tract infections | treatment | - |
Subjects
- Subject Type patients
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Number
Planned: 600
Actual: 118
- Sex male & female
- Age Group ≥ 18 years
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 |
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NCT04334512 | ClinicalTrials.gov: US National Institutes of Health |
PRG044 | - |
Trial Dates
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Initiation Dates
Planned : 01 May 2020
Actual : 22 Jun 2020
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Primary Completion Dates
Planned : 01 Jun 2023
Actual : 27 Feb 2024
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End Dates
Planned : 01 Sep 2024
Actual : 27 Feb 2024
Other Details
- Design double-blind; parallel; prospective; randomised
- Phase of Trial Phase II
- Location USA
- Focus Adverse reactions; Therapeutic Use
Interventions
Drugs | Route | Formulation |
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Ascorbic acidPrimary Drug |
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AzithromycinPrimary Drug |
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HydroxychloroquinePrimary Drug |
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Vitamin DPrimary Drug |
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ZincPrimary Drug |
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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 |
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Jordan Daniels, MS
217-494-6692
show details
msjordandaniels@gmail.com |
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Sabine Hazan, MD
805-200-7436
show details
sabinehazan@aim.com |
ProgenaBiome | USA |
Centres
Centre Name | Location | Trial Centre Country |
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- |
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ProgenaBiome |
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ProgenaBiome | Ventura, California | USA |
Trial History
Event Date | Event Type | Comment |
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04 Mar 2024 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 04 Mar 2024 |
27 Feb 2024 | Status change - completed | Status changed from recruiting to completed. Updated 04 Mar 2024 |
08 Jun 2021 | Completion date | Planned End Date changed from 1 Sep 2021 to 1 Sep 2024. Updated 11 Jun 2021 |
08 Jun 2021 | Other trial event | Planned primary completion date changed from 1 Jun 2021 to 1 Jun 2023. Updated 11 Jun 2021 |
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
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ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov
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