Safety of Chloroquine or Hydroxychloroquine Plus Azithromycin for the Treatment of COVID-19 Patients in Burkina Faso: An Observational Prospective Cohort Study

Figures & data

Table 1 Study Scheduled Visits

Follow-Up Parameters	Rhythm (Day)
	0	1	2	3	4	5	6	7	8–9	10	14	21
Informed consent	x
History (symptoms)	x			x				x		x	x
Examination (clinical)	x			x				x		x	x
Vital signs	x			x				x		x	x
Blood pressure	x			x				x		x	x
Body temperature	x			x				x		x	x
Electrocardiogram (ECG)	x							x			x
SARS-CoV-2 rRT-PCR	x			x				x		x	x	x*
CQ or HCQ treatment	x	x	x	x	x	x	x	x	x	x
Azithromycin treatment	x	x	x	x	x
Adverse drug reactions	x			x				x		x	x	x
Concomitant medications	x			x				x		x	x
Hematology	x							x			x
Biochemistry	x							x			x

Note: *If the test was positive on Day 21, the test was repeated until it became negative.

Abbreviation: rRT-PCR, real time reverse transcriptase polymerase chain reaction.

Table 2 Characteristics of the Population at Inclusion

Characteristics	Total No. = 153	Treatment
		HCQ + AZ No. = 128	CQ + AZ No. = 10	Not Treated No. = 14
Age
Median (IQR)	33.0 (16.2)	32.0 (16.0)	27.5 (13.8)	42.0 (11.0)
Min - max	16.0–89.0	16.0–89.0	21.0–48.0	22.0–61.0
Sex, n(%)
Female	52 (34.0)	41 (31.8)	2 (20.0)	9 (64.3)
Male	101 (66.0)	88 (68.2)	8 (80.0)	5 (35.7)
Marital status, n(%)
Single	71 (51.1)	61 (52.6)	6 (60.0)	4 (30.8)
In couple	68 (48.9)	55 (47.4)	4 (40.0)	9 (69.2)
Profession, n(%)
Informal sector	17 (11.7)	16 (13.0)	0 (0.0)	1 (8.3)
Teacher	6 (4.1)	5 (4.1)	1 (10.0)	0 (0.0)
Health worker	15 (10.3)	12 (9.8)	0 (0.0)	3 (25.0)
Farmer	5 (3.4)	4 (3.3)	0 (0.0)	1 (8.3)
Housewife	15 (10.3)	14 (11.4)	0 (0.0)	1 (8.3)
Student	34 (23.4)	30 (24.4)	4 (40.0)	0 (0.0)
Retired	3 (2.1)	2 (1.6)	0 (0.0)	1 (8.3)
Other	50 (34.5)	40 (32.5)	5 (50.0)	5 (41.7)
Educational level, n(%)
Non-formal education	3 (2.1)	2 (1.6)	0 (0.0)	1 (7.7)
No education at all	18 (12.3)	17 (13.8)	0 (0.0)	1 (7.7)
Primary education	12 (8.2)	11 (8.9)	0 (0.0)	1 (7.7)
Post-primary education	45 (30.8)	37 (30.1)	4 (40.0)	4 (30.8)
University	67 (45.9)	55 (44.7)	6 (60.0)	6 (46.2)
Weight (kg), Mean (SD)	72.8 (15.2)	73.2 (15.4)	64.3 (15.6)	75.8 (12.4)
Height (cm), Median (IQR)	170.0 (9.0)	171.0 (9.0)	167.0 (9.0)	170.5 (5.5)
Body mass index (kg/m^2) Mean (SD)	25.6 (6.4)	25.8 (6.8)	22.3 (4.3)	26.4 (4.1)
Charlson co -morbidity index, n(%)
0	126 (83.0)	103 (80.6)	10 (100.0)	13 (92.9)
1–2	22 (14.4)	21 (16.3)	0 (0.0)	1 (7.1)
3–4	4 (2.6)	4 (3.1)	0 (0.0)	0 (0.0)

Table 3 Distribution of Vital Signs at Inclusion by Treatment

Vital Signs	Total	Treatment
		HCQ + AZ	CQ + AZ	Not Treated
Oxygen saturation (SaO2), Median (IQR)	98.0 (3.0)	98.0 (0.0)	97.5 (2.0)	99.0 (1.0)
Temperature (°C), Median (IQR)	36.9 (0.8)	37.2 (0.7)	36.9 (0.8)	37.2 (0.4)
Fever (Temperature≥37.5°C), n(%)
Yes	20 (13.2)	4 (40.0)	13 (10.2)	3 (21.4)
No	132 (86.8)	6 (60.0)	115 (89.8)	11 (78.6)
Respiratory rate (c/min), Median (IQR)	19.0 (3.5)	21.0 (3.5)	19.0 (2.5)	18.5 (2.2)
Pulse (pulsations/min), Mean (SD)	84.8 (15.1)	96.2 (14.5)	84.6 (14.7)	78.6 (14.8)
Blood pressure (mmHg), Median (IQR)
Systolic	126.5 (20.8)	110.0 (18.0)	129.0 (21.0)	127.5 (17.8)
Diastolic	81.0 (17.0)	75.0 (10.0)	82.0 (17.0)	86.5 (19.5)

Table 4 Adverse Events Reported During Participant’s Follow-Up According to Treatment Received

Adverse Events, n (%)	Total	Treatment			p value
		HCQ + AZ	CQ + AZ	Not Treated
# of adverse events	42	34	7	2	0.71
Name of adverse events
Pruritus	5	3 (60.0)	2 (40.0)	0 (0.0)
Diarrhea	4	3 (75.0)	1 (25.0)	0 (0.0)
High blood pressure	4	3 (75.0)	0 (0.0)	1 (25.0)
Headache	3	3 (100)	0 (0.0)	0 (0.0)
Chest pain	3	2 (66.7)	1 (33.3)	0 (0.0)
Jaundice	2	2 (100)	0 (0.0)	0 (0.0)
Palpitations	2	1 (50.0)	1 (50.0)	0 (0.0)
Anemia	1	1 (100)	0 (0.0)	0 (0.0)
Anorexia	1	1 (100)	0 (0.0)	0 (0.0)
Cramp + paresthesia	1	1 (100)	0 (0.0)	0 (0.0)
Diarrhea + abdominal pain	1	1 (100)	0 (0.0)	0 (0.0)
Breathing difficulties	1	1 (100)	0 (0.0)	0 (0.0)
Dysarthria	1	0 (0.0)	1 (100)	0 (0.0)
Epigastralgia	1	1 (100)	0 (0.0)	0 (0.0)
Skin rash	1	0 (0.0)	1 (100)	0 (0.0)
Insomnia	1	1 (100)	0 (0.0)	0 (0.0)
Renal failure	1	1 (100)	0 (0.0)	0 (0.0)
Septic monoarthritis	1	1 (100)	0 (0.0)	0 (0.0)
Uncomplicated malaria	1	1 (100)	0 (0.0)	0 (0.0)
Pleurisy	1	1 (100)	0 (0.0)	0 (0.0)
Pneumonia	1	1 (100)	0 (0.0)	0 (0.0)
Somnolence	1	1 (100)	0 (0.0)	0 (0.0)
Infectious syndrome	1	1 (100)	0 (0.0)	0 (0.0)
Tachycardia	1	1 (100)	0 (0.0)	0 (0.0)
Cough	1	1 (100)	0 (0.0)	0 (0.0)
Vomiting	1	1 (100)	0 (0.0)	0 (0.0)

Figure 1 Change in corrected QT interval by Fredericia (QTcF) values during follow-up according to the treatment received

Figure 2 Viral cleareance during the follow-up