BREAKING STUDY: Hydroxychloroquine Proven Safe with No Evidence of Cardiac Complications

Cardiac findings in a phase II double-blind randomized placebo-controlled trial of combination therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, Zinc) to treat COVID-19 patients

by Nicolas Hulscher, MPH

The ProgenaBiome and McCullough Foundation study titled Cardiac findings in a phase II double-blind randomized placebo-controlled trial of combination therapy (HAZDPac) to treat COVID-19 patients, co-authored by Sabine Hazan, Adriana C. Vidal, Nicolas Hulscher, Amelia Goudzwaard, Peter A. McCullough & Alon A. Steinberg, was just published in the journal BMC Cardiovascular Disorders:

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.

None of the COVID-19 patients treated with HAZDPac experienced severe adverse events or mortality, underscoring the safety and potential efficacy of this therapy. Our findings provide strong evidence to counter the notion that hydroxychloroquine is unsafe due to QTc interval prolongation, as no significant changes to abnormal QTc ranges were observed compared to placebo in this rigorously monitored outpatient trial:

Hydroxychloroquine has been a controversial drug due to the speculation that either alone or paired with azithromycin taken orally leads to a prolonged QTc interval and Torsade de Pointes, particularly in an inpatient hospital setting [10,11,12,13]. Yet, in this outpatient setting study conducted by ProgenaBiome, a private research clinic located in Ventura, California, such cardiac findings of patients treated with Hydroxychloroquine, paired with Azithromycin, Vitamin C, Vitamin D, and Zinc (HAZDPac) did not reflect previous concerns. The mean maximum QTc value found in the data we gathered from treated patients’ continuously worn EKG monitor was 437 ms (SD = 32), which falls into the normal range for both males and females, QTc normal range for males is 350–450 ms, and for females is 360–460 ms [14].

Our study was published just as the Academic Publishing Cartel unethically retracted the study, Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. This landmark study, which demonstrated hydroxychloroquine's benefit against COVID-19, was published for four years and cited by 6,713 scientists, physicians, and researchers before being unjustly removed. One way the Biopharmaceutical Complex promotes their genetic injections is by censoring and attacking cheaper, safer, and more effective treatments like hydroxychloroquine.

Despite the strong headwinds of censorship, we will continue to conduct, support, and disseminate truthful, high-quality research to serve public health and uphold scientific integrity.

Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

www.mcculloughfnd.org

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