Hydroxychloroquine-azithromycin, doubase C, and QTc prolongation in congolese patients with COVID-19: Myth or reality?

Table 1 Baseline characteristics of patients

Variables	Whole group, n = 261	Doubase C, n = 138	HCQ-AZI, n = 123	P value
Age	41.0 ± 14.8	40.5 ± 15.3	41.5 ± 14.2	0.581
Men/women	137/134	64/74	73/50	0.036
BMI	26.1 ± 5.4	26.4 ± 5.7	25.6 ± 5.0	0.249
O2pSa	96.9 ± 2.0	97.0 ± 1.7	96.9 ± 2.3	0.449
Hypertension	29 (11.1)	18 (13.0)	11 (8.9)	0.569
Diabetes	9 (3.4)	7 (5.1)	2 (1.6)	0.197
HIV	1 (0.4)	1 (0.7)	0	0.386
Asthma	6 (2.3)	3 (2.2)	3 (2.4)	0.744
Tuberculosis	1 (0.4)	1 (0.7)	0	0.383
Hemoglobin (g/dL)	13 ± 3	13.7 ± 3.2	13.5 ± 2.2	0.673
Creatinine (mg/dL)	0.97 ± 0.30	0.96 ± 0.31	0.99 ± 0.25	0.420
ALAT (UI/L)	25 ± 16	23 ± 14	27 ± 18	0.064
ASAT (UI/L)	28 ±12	29 ± 14	26 ± 11	0.141
K+ (mmol/L)	4.2 ± 2.0	3.9 ± 1.0	3.8 ± 0.11	0.167
Ca2+ (meq/L)	1.17 ± 0.11	1.15 ± 0.11	1.18 ± 0.11	0.430

The results are presented as means and standard deviations or as absolute frequencies (percentages). BMI: Body mass index; HIV: Human immunodeficiency virus; ALAT: Alanine aminotransferase; ASAT: Aspartate aminotransferase; HCQ-AZI: Hydroxychloriquine and azithromycin.

Table 2 Baseline characteristics of electrocardiograms

ECG parameter	Participants, n = 261	Doubase C, n = 138	HCQ-AZI, n = 123	P value
Sinus rhythm	261 (100)	123 (100)	138 (100)
Heart rate (/min)	78 ± 13	79 ± 13	77 ± 13	0.420
P wave (ms)	114 ± 10	113 ± 12	115 ± 8	0.495
PR space (ms)	170 ± 28	172 ± 30	168 ± 26	0.331
QRS complex (ms)	76 ± 13	76 ± 14	76 ± 12	0.839
T-wave (ms)	193 ± 32	193 ± 30	194 ± 34	0.679
QTc interval (ms)	405 ± 30	406 ± 31	401 ± 29	0.193
Sokolow- Lyon (mm)	24.5 ± 8.9	25.0 ± 10.1	23.1 ± 8.0	0.611

HCQ-AZI: Hydroxychloriquine and azithromycin.

Table 3 Electrocardiogram changes after treatment (day 14 of randomization)

Variable	Days 14-1	Day 1	Day 14	P value
Heart rate (/min)	0.820	78 ± 13	79 ± 12	0.343
P wave (ms)	1.010	114 ± 10	115 ± 13	0.314
PR space (ms)	8.232	170 ± 28	177 ± 36	0.001
QRS complex (ms)	0.469	76 ± 13	76 ± 13	0.560
QTc interval (ms)	8.835	405 ± 30	413 ± 35	< 0.001
T-wave (ms)	3.867	193 ± 32	197 ± 42	0.197
Sokolow–Lyon (mm)	0.004	24.5 ± 8.9	24.5 ± 8.5	0.990

Table 4 Proportion of patients who experienced prolongation of QTc after treatment

Treatment	QTc, ≥ 500 ms		QTc, < 500 ms		P value	QTc increase, 80 ms		No QTc irncrease		P value
	n	%	n	%		n	%	n	%
HCQ-AZI	4	3.3	117	96.7	0.047	5	4.1	116	95.9	0.021
Doubase C	0	0	137	100		0	0	137	100

HCQ-AZI: Hydroxychloriquine and azithromycin.

Table 5 Risk of electrocardiogram pattern changes (QTc prolongation) in each subgroup

Variables	QTc prolongation		P value
	Day 1, n = 261	Day 14, n = 258
Men	0	1	0.500
Women	0	4	0.061
Age < 40 yr	0	5	0.031
Obesity	0	2	0.247
Normal and overweight	0	3	0.124
CtN2 or CtE < 33	0	5	0.030
HCQ-AZI	0	5	0.030

CtE: Cycle threshold value of envelope genes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); CtN2: Cycle threshold value of nucleoprotein genes of SARS-CoV-2; HCQ-AZI: Hydroxychloriquine and azithromycin.