Cardiac Safety in COVID-19 Treatment: HAZDPac Study
Objective
The study aimed to evaluate the safety of a combination therapy called HAZDPac for treating COVID-19 patients. This therapy includes Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc. We focused on concerns regarding heart rhythm issues and QTc interval prolongation.
Study Design
This was a Phase II double-blind randomized placebo-controlled trial conducted by ProgenaBiome. We monitored the heart’s QTc intervals of COVID-19 patients using a continuous EKG monitor throughout a 10-day treatment period.
Results
From March 2020 to June 2021, we recruited 118 COVID-19 patients, with 83 entering the trial. Of these, 52 received HAZDPac treatment, while 31 received a placebo. The results showed:
- QTc values for the treatment group were normal.
- No significant differences were found between the treatment and placebo groups (p ≥ 0.15).
- There were no adverse events related to the HAZDPac treatment.
Conclusion
HAZDPac treatment for COVID-19 did not lead to QTc interval prolongation and remained within normal limits, indicating it is safe for use in outpatient settings.
Clinical Trial Registration
Clinical Trial NCT04482686, registered on clinicaltrials.gov on 07/21/2020.
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