Hydroxychloroquine-azithromycin, doubase C, and QTc prolongation in congolese patients with COVID-19: Myth or
Brady Madioko Makanzu1, Jean-Robert Makulo2, Madone Ndona Mandina3
1Department of Cardiology, Kinshasa University Hospital, Kinshasa, DR Congo, Kinshasa University Hospital, Kinshasa 11, Congo. bmaknzu@gmail.com.
Insights
Hydroxychloroquine (HCQ) and azithromycin (AZI) treatment for COVID-19 showed lower QTc prolongation rates compared to doubase C. This study found no torsade de pointes (Tsd) in either treatment group, suggesting a potentially safer profile for HCQ-AZI in specific patient populations.
Area of Science:
- Cardiology
- Infectious Diseases
- Pharmacology
Background:
- QTc interval prolongation and torsade de pointes (Tsd) risk associated with hydroxychloroquine (HCQ) and azithromycin (AZI) in COVID-19 patients is a known concern.
- Limited research exists on the safety of this drug combination and alternative treatments in the Democratic Republic of Congo.
Purpose of the Study:
- To compare the incidence of QTc prolongation and Tsd in COVID-19 patients treated with HCQ-AZI versus a new molecule, doubase C.
- To evaluate the safety profile of HCQ-AZI and doubase C in a randomized clinical trial setting.
Main Methods:
- A randomized clinical trial included patients with mild to moderate COVID-19 receiving either HCQ-AZI or doubase C.
- Electrocardiogram (ECG) assessments were performed on day 14 post-randomization, comparing QTc intervals to baseline.
- Prolonged QTc was defined as ≥ 500 ms or an increase of ≥ 80 ms from baseline; patients with cardiac conditions or confounding medications were excluded.
Main Results:
- The study enrolled 258 patients; 1.5% experienced QTc prolongation (>500 ms) and 1.9% had a QTc increase (>80 ms).
- QTc prolongation was more pronounced in younger patients, those with high baseline viral load, and those receiving HCQ-AZI (P < 0.05).
- No cases of Tsd were reported in either treatment group.
Conclusions:
- QTc prolongation occurred less frequently in patients treated with HCQ-AZI compared to doubase C, with no Tsd observed.
- The absence of comorbidities and concurrent use of QTc-prolonging medications may have contributed to the observed safety profile.
Background:
QTc interval prolongation with an increased risk of torsade de pointes (Tsd) has been described in coronavirus disease 2019 (COVID-19) patients treated with hydroxychloroquine (HCQ) and azithromycin (AZI) in Western countries. In the DR Congo, few studies have evaluated the safety of this association or proposed new molecules.
Aim:
To determine the incidence of QTc prolongation and Tsd in COVID-19 patients treated with HCQ-AZIs vs doubase C (new molecule).
Methods:
In present randomized clinical trial, we have included patients with mild or moderate COVID-19 treated with either HCQ-AZI or doubase C. Electrocardiogram (ECG) changes on day 14 of randomization were determined based on pretreatment tracing. Prolonged QTc was defined as ≥ 500 ms on day 14 or an increase of ≥ 80 ms compared to pretreatment tracing. Patients with cardiac disease, those undergoing other treatments likely to prolong QTc, and those with disturbed ECG tracings were excluded from the study.
Results:
The study included 258 patients (mean age 41 ± 15 years; 52% men; 3.4% diabetics, 11.1% hypertensive). Mild and moderate COVID-19 were found in 93.5% and 6.5% of patients, respectively. At baseline, all patients had normal sinus rhythm, a mean heart rate 78 ± 13/min, mean PR space 170 ± 28 ms, mean QRS 76 ± 13 ms, and mean QTc 405 ± 30 ms. No complaints suggesting cardiac involvement were reported during or after treatment. Only four patients (1.5%) experienced QTc interval prolongation beyond 500 ms. Similarly, only five patients (1.9%) had an increase in the QTc interval of more than 80 ms. QTc prolongation was more significant in younger patients, those with high viral load at baseline, and those receiving HCQ-AZI (P < 0.05). None of the patients developed Tsd.
Conclusion:
QTc prolongation without Tsd was observed at a lower frequency in patients treated with HCQ-AZI vs doubase C. The absence of comorbidities and concurrent use of other products that are likely to cause arrhythmia may explain our results.
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