A randomized, double-blind study on the efficacy of oral domperidone versus placebo for reducing SARS-CoV-2 viral load in mild-to-moderate COVID-19 patients in primary health care

Figures & data

Figure 1. Flow chart of the study population. Analysis was based on the ITT dataset.

Table 1. Demographic, baseline physical exam and previous SARS-CoV-2 infection in the study groups.

Variables	Total patients (n = 173)		Placebo (n = 86)		Domperidone (n = 87)		p value
	N (%)	Mean (SD)	N (%)	Mean (SD)	N (%)	Mean (SD)
Gender
Male	64 (37)		33 (38.4)		31 (35.6)		0.709
Female	109 (63)		53 (61.6)		56 (64.4)
Age (years)		47.8 (1.2)		47.7 (1.7)		47.8 (1.6)
Race
Caucasian	154 (89)		74 (86)		80 (92)		0.431
Black	1 (0.6)		1 (1.2)		0
Hispanic	17 (9.8)		10 (11.6)		7 (8)
Asiatic	1 (0.6)		1 (1.2)		0
Body mass index (kg/m^2)		26 (0.4)		26.6 (0.6)		25.5 (0.5)	0.323
Systolic BP (mmHg)		124.6 (1)		124.4 (1.5)		124.7 (1.3)	0.890
Diastolic BP (mmHg)		76.7 (0.8)		76.4 (1.1)		77 (1)	0.719
Respiratory rate (breaths/min)		15.9 (0.4)		15.6 (0.4)		16.3 (0.8)	0.389
Oxygen saturation (%)		97.2 (0.1)		97.1 (0.1)		97.3 (0.1)	0.318
Heart rate (beats/min)		81.8 (1)		83.1 (1.5)		80.6 (1.3)	0.306
Axillary temperature (°x)		36.4 (0.1)		36.5 (0.1)		36.4 (0.1)	0.788
Previous COVID-19 infection
No	146 (84.4)		73 (84.9)		73 (83.9)		0.860
Yes	27 (15.6)		13 (15.1)		14 (16.1)
Severity of previous COVID-19 infection
Asymptomatic	1 (3.7)		1 (7.7)		0
Mild	17 (63)		10 (76.9)		7 (50)
Moderate	8 (29.6)		2 (15.4)		6 (42.9)
Severe	1 (3.7)		0		1 (7.1)
Time from previous SARS-CoV-2 infection (months)		14.2 (1.7)		12.6 (2.6)		15.8 (2.1)	0.342

SD: standard deviation.

Table 2. Symptoms observed at baseline: frequency and severity (0–10 points of a NRS) compared by study group.

Symptom	Study group	N Placebo (n = 87) Domperidone (n = 86)	Percentage of patients presenting the symptom (%)	Symptom severity mean (SD)	p value for symptom severity comparison
Fever	Placebo	41	47.7	–
	Domperidone	41	47.1	–
Cough	Placebo	67	77.9	5.30 (2.30)	0.705
	Domperidone	68	78.2	5.44 (2.08)
Odynophagia	Placebo	53	61.6	5.70 (2.30)	0.645
	Domperidone	50	57.5	5.48 (2.48)
Dyspnoea	Placebo	7	8.1	3.71 (2.29)	0.353
	Domperidone	4	4.6	5.00 (1.63)
Chest pain	Placebo	8	9.3	5.75 (2.87)	0.562
	Domperidone	13	14.9	6.39 (2.06)
Chills	Placebo	17	19.8	5.65 (2.03)	0.574
	Domperidone	17	19.5	5.24 (2.19)
Nausea	Placebo	11	12.8	4.27 (2.53)	0.157
	Domperidone	13	14.9	5.77 (2.45)
Vomiting	Placebo	3	3.5	5.00 (4.36)	0.615
	Domperidone	2	2.3	3.00 (2.83)
Diarrhoea	Placebo	11	12.8	5.91 (2.43)	0.563
	Domperidone	10	11.5	5.20 (3.08)
Abdominal pain	Placebo	2	2.3	5.00 (4.24)	0.637
	Domperidone	5	5.8	6.20 (2.39)
Nasal congestion	Placebo	54	62.8	6.06 (2.24)	0.095
	Domperidone	50	57.5	6.76 (2.02)
Anosmia	Placebo	6	7	7.17 (2.93)	0.903
	Domperidone	9	10.3	7.33 (2.29)
Dysgeusia	Placebo	3	3.5	6.33 (3.06)	0.963
	Domperidone	12	13.8	6.42 (2.68)
Headache	Placebo	55	64	6.35 (2.15)	0.466
	Domperidone	54	62.1	6.04 (2.25)
Myalgia	Placebo	39	45.4	6.77 (2.06)	0.996
	Domperidone	35	40.2	6.77 (2.17)
Arthralgia	Placebo	13	15.1	7.00 (2.20)	0.191
	Domperidone	20	23	5.85 (2.54)
Weariness	Placebo	51	59.3	6.98 (2.06)	0.167
	Domperidone	53	60.9	6.34 (2.59)
Weakness	Placebo	22	25.6	6.55 (1.84)	0.781
	Domperidone	24	27.6	6.38 (2.24)
Anorexia	Placebo	18	20.9	6.67 (2.09)	0.087
	Domperidone	16	18.4	7.81 (1.64)
Dizziness	Placebo	9	10.5	5.44 (2.56)	0.775
	Domperidone	6	6.9	5.83 (2.48)
Vertigo	Placebo	0	0	–	–
	Domperidone	1	1.2	3.00
Anxiety	Placebo	1	1.2	6.00	–
	Domperidone	0	0	–
Insomnia	Placebo	3	3.5	6.00 (1.73)	0.768
	Domperidone	3	3.5	7.00 (5.20)
Facial pain	Placebo	1	1.2	10.00	0.317
	Domperidone	3	3.5	7.67 (1.53)
Dysphonia	Placebo	5	5.8	5.00 (2.00)	0.581
	Domperidone	10	11.5	5.70 (2.36)
Otalgia	Placebo	3	3.5	6.67 (0.58)	0.004
	Domperidone	2	2.3	10.00 (0.01)
Dry eye	Placebo	1	1.2	7.00	–
	Domperidone	0	0	–
Blurred vision	Placebo	1	1.2	6.00	–
	Domperidone	1	1.2	5.00
Foreign body sensation	Placebo	2	2.3	6.00 (1.41)	–
	Domperidone	0	0	–
Conjunctival congestion	Placebo	1	1.2	9.00	0.454
	Domperidone	2	2.30	7.00 (1.41)

Figure 2. Evolution of Ct values of ORF1ab, N Protein and S Protein at follow-up in the two study groups.

Figure 3. Kaplan–Meier curves for the median time to obtain an RT-qPCR negative result by study group.

Table 3. Persistent symptoms observed after 28 days of follow-up by study groups.

Symptom	Total (n = 173)	Placebo (n = 86)	Domperidone (n = 87)	p value
	N (%)	N (%)	N (%)
Fever	1 (1.6)	1 (3.8)	0	–
Cough	18 (29)	6 (23.1)	12 (33.3)	0.157
Odynophagia	2 (3.2)	0	2 (5.6)	–
Dyspnoea	1 (1.6)	1 (3.8)	0	–
Chest pain	1 (1.6)	0	1 (2.8)	–
Nausea	1 (1.6)	0	1 (2.8)	–
Nasal congestion	4 (6.5)	1 (3.8)	3 (8.3)	0.317
Anosmia	3 (4.8)	1 (3.8)	2 (5.6)	0.564
Dysgeusia	1 (1.6)	1 (3.8)	0	–
Headache	3 (4.8)	2 (7.7)	1 (2.8)	0.564
Myalgia	3 (4.8)	1 (3.8)	2 (5.6)	0.564
Arthralgia	2 (3.2)	2 (7.7)	0	–
Weariness	13 (21)	6 (23.1)	7 (19.4)	0.782
Weakness	3 (4.8)	1 (3.8)	2 (5.6)	0.564
Anorexia	4 (6.5)	1 (3.8)	3 (8.3)	0.317
Anxiety	1 (1.6)	1 (3.8)	0	–
Blurred vision	1 (1.6)	1 (3.8)	0	–

%: Percentage of persistent symptoms in each group.

Data availability statement

The datasets used and analysed during the current study are available from the corresponding authors upon reasonable request.