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Macrolide Antibiotic

Quintuple Therapy for COVID-19 (HAZDpaC Trial)

Phase 2
Waitlist Available
Led By Sabine Hazan, MD
Research Sponsored by ProgenaBiome
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Treatment with any of the medications listed in Appendix II
Treatment with any anti-epileptic drug, whether prescribed for seizures or otherwise
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 30 Other Conditions

Summary

This trial will test if a mix of 5 drugs can effectively treat people with COVID-19 infection.

Who is the study for?
Adults diagnosed with COVID-19 can join this trial. They must use two effective birth control methods if of reproductive potential, understand the study's purpose and procedures, and have a confirmed diagnosis by RT-PCR. People with certain health conditions like heart rhythm problems, severe muscle weakness or blood disorders are excluded.
What is being tested?
The trial is testing a combination therapy for COVID-19 that includes Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc to see how well it works in treating the infection.
What are the potential side effects?
Possible side effects may include stomach issues from Azithromycin or Hydroxychloroquine; changes in heart rhythm; vision problems; liver issues; low blood sugar levels; skin reactions in those with psoriasis; and anemia.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication listed in Appendix II.
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I am currently taking medication for epilepsy.
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I have myasthenia gravis.
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I refuse to give my consent for participation.
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I have low blood sugar levels.
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I had jaundice or high fevers before getting COVID-19.
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I have a heart condition with prolonged QT on my EKG.
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I have been diagnosed with G6PD deficiency.
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I have a condition affecting the central part of my retina.
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I have porphyria.
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I have experienced changes in my field of vision.
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I have anemia.
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I have anemia caused by pyruvate kinase or G6PD deficiency.
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I am not taking any medications that affect heart rhythm.
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I have no health issues that prevent me from taking hydroxychloroquine.
Select...
I have a muscle disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess Tolerability of Quintuple Therapy
Assess the safety of Quintuple Therapy
Assess the safety of Quintuple Therapy via EKG
+4 more

Side effects data

From 2022 Phase 4 trial • 42 Patients • NCT05027516
9%
pain at injection site
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rocephine®
Rocephine® + Azithromycin

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Quintuple TherapyExperimental Treatment5 Interventions
Patients will be treated with quintuple therapy for 10 days.
Group II: PlaceboPlacebo Group3 Interventions
Patients will be treated with placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin C
2017
Completed Phase 4
~18470
Vitamin D
2013
Completed Phase 4
~3670
Azithromycin
FDA approved
Hydroxychloroquine
FDA approved
Zinc
2005
Completed Phase 4
~16490

Find a Location

Who is running the clinical trial?

ProgenaBiomeLead Sponsor
45 Previous Clinical Trials
5,232 Total Patients Enrolled
DSCS CROIndustry Sponsor
2 Previous Clinical Trials
618 Total Patients Enrolled
Sabine Hazan, MDPrincipal InvestigatorProgenaBiome
40 Previous Clinical Trials
4,911 Total Patients Enrolled

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04334512 — Phase 2
Coronavirus Research Study Groups: Quintuple Therapy, Placebo
Coronavirus Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT04334512 — Phase 2
Azithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04334512 — Phase 2
~22 spots leftby Nov 2025
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