Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2024 Dec 19;24(1):710.
doi: 10.1186/s12872-024-04376-y.

Cardiac findings in a phase II double-blind randomized placebo-controlled trial of combination therapy (HAZDPac) to treat COVID-19 patients

Sabine Hazan  1   2 , Adriana C Vidal  3   4 , Nicolas Hulscher  5 , Amelia Goudzwaard  3   4 , Peter A McCullough  5 , Alon A Steinberg  6
Affiliations
Clinical Trial

Cardiac findings in a phase II double-blind randomized placebo-controlled trial of combination therapy (HAZDPac) to treat COVID-19 patients

Sabine Hazan et al. BMC Cardiovasc Disord. .

Retraction in

Abstract

Objective: Hydroxychloroquine paired with Azithromycin, Vitamin C, Vitamin D, and Zinc (HAZDPac), was used as a multidrug therapy method to treat COVID-19 illness and superimposed secondary bacterial pneumonia. Concerns have been raised though about such combinations regarding cardiac QTc interval prolongation and risks of arrhythmias, which we set out to address in this study.

Design: We evaluated cardiac safety in a Phase II Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infections study, conducted by ProgenaBiome. Acutely ill patients with COVID-19 had QTc intervals recorded in an outpatient setting utilizing a continuously worn EKG monitor for the duration of the 10 days treatment. QTc intervals were normally distributed. Two-sample t-tests were used to measure any significant differences in QTc intervals between treatment and placebo groups.

Results: Between March 2020 and June 2021, 118 COVID-19 patients were recruited and signed informed consent, of which 83 were enrolled for a Double-Blind Randomized Placebo-Controlled Trial. Of the 83, 52 patients were randomly assigned to receive HAZDPac treatment, and 31 patients to receive placebo. Overall, and in stratified analysis by gender, maximum QTc values of patients in the treatment arm were normal and no differences were observed when compared to maximum QTc values from patients in the placebo arm (p ≥ 0.15). There were no adverse events related to HAZDPac treatment.

Conclusion: We found that the outpatient treatment of COVID-19 patients with HAZDPac which includes Hydroxychloroquine and Azithromycin, was not associated with prolongation of QTc compared to placebo and QTc remained within normal range.

Clinical trial: Clinical Trial NCT04482686, clinicaltrials.gov, date of registration 07/21/2020.

Keywords: Azithromycin; COVID-19; Hydroxychloroquine; QTc interval; Safety.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study involves human participants, and the study protocol was reviewed and approved by The Salus Institutional Review Board, Protocol #20071 and registered at Clinicaltrials.gov, Identifier NCT04482686. Participants gave informed consent to participate in the study before taking part. Consent for publication: All authors gave consent for publication. Participants gave written informed consent for their unidentified personal or clinical details along with any images to be published in this study. Competing interests: Dr Hazan is the CEO of Progenabiome, LLC and owns the Microbiome Research Foundation. Dr. McCullough owns the McCullough Foundation. Disclosures: Dr Hazan is the CEO of Progenabiome, LLC and owns the Microbiome Research Foundation. Dr. McCullough owns the McCullough Foundation.

Figures

Fig. 1
Fig. 1
Consort flow diagram
Fig. 2
Fig. 2
Example QTc interval derived from a study participant before and after 9 days of HAZDPac treatment
See this image and copyright information in PMC

References

    1. Kai-Wang To K, Tak-Yin Tsang O, Chik-Yan Yip C, Chan KH, Wu TC, Chan M-C. Consistent detection of 2019 novel coronavirus in saliva. Clin Infect Dis. 2020;12:ciaa149. - PMC - PubMed
    1. WHO. Transmission of SARS-CoV-2: implications for infection prevention precautions. 2020.
    1. Meyerowitz EA, Richterman A, Gandhi RT, Sax PE. Transmission of SARS-CoV-2: a review of viral, host, and environmental factors. Ann Intern Med. 2021;174(1):69–79. - PMC - PubMed
    1. Lei ZN, Wu ZX, Dong S, Yang DH, Zhang L, Ke Z, Zou C, Chen ZS. Chloroquine and hydroxychloroquine in the treatment of malaria and repurposing in treating COVID-19. Pharmacol Ther. 2020;216:107672. - PMC - PubMed
    1. Bansal P, Goyal A, Cusick A 4th, Lahan S, Dhaliwal HS, Bhyan P, Bhattad PB, Aslam F, Ranka S, Dalia T, Chhabra L, Sanghavi D, Sonani B, Davis JM 3. rd. hydroxychloroquine: a comprehensive review and its controversial role in coronavirus disease 2019. Ann Med. 2021;53(1):117–34. - PMC - PubMed

Publication types

MeSH terms

Associated data