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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

HAZDpaC Trial 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.Check my eligibility

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.See study design

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.

HAZDpaC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 2018 Phase 4 trial • 190238 Patients • NCT02047981

Death

100%

80%

60%

40%

20%

Study treatment Arm

Biannual Mass Oral Placebo

Biannual Mass Oral Azithromycin

HAZDpaC 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

~3470

Azithromycin

FDA approved

Hydroxychloroquine

FDA approved

Zinc

2005

Completed Phase 4

~17050

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ProgenaBiomeLead Sponsor

44 Previous Clinical Trials

5,212 Total Patients Enrolled

6 Trials studying COVID-19

1,181 Patients Enrolled for COVID-19

DSCS CROIndustry Sponsor

2 Previous Clinical Trials

618 Total Patients Enrolled

1 Trials studying COVID-19

600 Patients Enrolled for COVID-19

Sabine Hazan, MDPrincipal InvestigatorProgenaBiome

40 Previous Clinical Trials

4,911 Total Patients Enrolled

6 Trials studying COVID-19

1,181 Patients Enrolled for COVID-19

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04334512 — Phase 2

COVID-19 Research Study Groups: Quintuple Therapy, Placebo

COVID-19 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions have been effectively treated with Azithromycin?

"Azithromycin is regularly prescribed to treat genital ulcer disease (GUD), but can be used in adults suffering from other afflictions such as Q Fever or Chlamydia."

Answered by AI

Is there availability for prospective participants in this research project?

"Data hosted on clinicaltrials.gov states that this experiment is still searching for participants and was first posted in June of 2020 with the most recent update being September 2021."

Answered by AI

Have prior investigations been conducted with Azithromycin?

"At present, 115 clinical trials researching Azithromycin are live with 23 of them in Phase 3. Hangzhou, Zhejiang is the epicentre for most studies but 1464 other sites around the world are running investigations into this drug."

Answered by AI

What is the cap on participant enrollment for this clinical research?

"Yes, clinicaltrials.gov confirms that this trial is still actively seeking volunteers; the initial posting date was June 22nd 2020 and it has most recently been updated on September 2nd 2021. The research team needs to enroll 600 participants from a single centre."

Answered by AI

What risks might be posed by prescribing Azithromycin to a patient?

"The safety rating for Azithromycin was set at 2, due to a lack of substantial evidence demonstrating its efficacy despite Phase 2 clinical data affirming the drug's relative security."

Answered by AI