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

"Discussion: We found that hydroxychloroquine in conjunction with other drugs used in standard-of-care for ambulatory acute COVID-19 did not impact the QTc interval measured in an assiduous continuous monitoring environment. 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. 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 ...

The present results agree with similar data reported in larger cohort studies ... 

This brings us to discuss two major points that are not well addressed in the meta-analysis of hydroxychloroquine clinical trials conducted worldwide. One is the dose of hydroxychloroquine prescribed to patients, and another is how early in the treatment hydroxychloroquine was given, including to patients with severe COVID-19 already hospitalized, when hydroxychloroquine may not be as effective. In the RECOVERY trial, patients received an initial 800 mg dose of hydroxychloroquine, followed by 400 mg every 12 h for up to 9 days or until discharge. In the WHO SOLIDARITY trial, patients received 800 mg of hydroxychloroquine at hour 0, another 800 mg at hour 6, and then 400 mg twice daily starting at hour 12 for 10 days. Both trials included hospitalized COVID-19 patients that were given relatively high doses of hydroxychloroquine, which may have influenced the observed mortality outcomes associated with hydroxychloroquine. Our study shows that early outpatient administration of HAZDPac, which included 200 mg Hydroxychloroquine twice a day for 10 days, was safe in treating COVID-19 with no adverse effects, no prolonged QTc and no cardiac arrythmias or events. A recent review article on cardiac biomarkers studies among COVID-19 patients highlights the importance of identifying early the most serious patients in order to optimize their outcomes. These biomarkers should be considered in patient settings where there are doubts about the safety of Hydroxychloroquine among patients with a history of heart disease."