Efficacy and Safety of Ivermectin and Hydroxychloroquine in Patients with Severe COVID-19: A Randomized Controlled Trial
Abstract
:1. Introduction
2. Methodology
3. Statistical Analysis
4. Results
5. Discussion
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variables | Entire Group (n = 106) | Hydroxychloroquine (n = 33) | Ivermectin (n = 36) | Placebo (n = 37) | p |
---|---|---|---|---|---|
Age, m (±S) | 53.8 (16.9) | 48.9 (15.3) | 56 (16.5) | 53.8 (16.9) | 0.15 |
Males, n (%) | 66 (62.2) | 22 (66.6) | 21 (58.3) | 23 (62.1) | 0.77 |
Diabetes Mellitus, n (%) | 36 (33.9) | 11 33.3) | 9 (25) | 16 (43.2) | 0.25 |
SAH, n (%) | 34 (32.1) | 8 (24.2) | 12 (33.3) | 14 (37.8) | 0.47 |
CKD, n (%) | 5 (4.7) | 2 (6.1) | 2 (5.5) | 1 (2.7) | 0.73 |
COPD, n (%) | 7 (6.6) | 1 (3) | 2 (5.5) | 4 (10.8) | 0.50 |
Healthy, n (%) | 30 (28.3) | 13 (39.3) | 10 (27.7) | 7 (18.9) | 0.17 |
Weight, m (±S) | 82.3(19.6) | 84.8 (20.8) | 80 (19.7) | 82 (18.2) | 0.66 |
BMI, m (±S) | 29.6 (6.6) | 30.3 (6.3) | 29.2 (7) | 29.4 (6.6) | 0.55 |
D symptoms onset, med (±IQR) | 7 (4–10) | 7 (5–12) | 6 (4–10) | 7 (5–10) | 0.84 |
D of +RT-PCR, med (IQR) | +1 (0–2) | +1 (−1–2) | +1 (0–2) | +1 (1–2) | 0.41 |
Variables, n (%) | Entire Group (n = 93) | Hydroxychloroquine (n = 28) | Ivermectin (n = 30) | Placebo (n = 35) |
---|---|---|---|---|
CO-RADS 2 | 5 (5.3) | 0 | 3 (10) | 2 (5.2) |
CO-RADS 3 | 15 (16.1) | 4 (14.2) | 7 (23.3) | 4 (11.4) |
CO-RADS 4 | 19 (20.4) | 7 (25) | 4 (13.3) | 8 (22.8) |
CO-RADS 5 | 50 (53.7) | 17 (25) | 13 (43.3) | 20 (57.1) |
CO-RADS 6 | 4 (4.3) | 0 | 3 (10) | 1 (2.8) |
Variables | Entire Group (n = 106) | Hydroxychloroquine (n = 33) | Ivermectin (n = 36) | Placebo (n = 37) | p |
---|---|---|---|---|---|
SatO2, m (±S) | 84 (7) | 86 (9) | 83 (8) | 83 (8) | 0.27 |
PaO2/FiO2, m (±S) | 223 (103) | 224 (116) | 245 (107) | 201 (82) | 0.17 |
<100, n (%) | 11 (10.3) | 5 (15.1) | 2 (5.5) | 4 (10.8) | 0.44 |
100–200, n (%) | 31 (29.2) | 8 (24.2) | 9 (25) | 14 (37.8) | 0.36 |
>200–300, n (%) | 48 (45.2) | 17 (51.5) | 16 (44.4) | 15 (40.5) | 0.64 |
>300, n (%) | 16 (15.1) | 3 (9.1) | 9 (25) | 4 (10.8) | 0.14 |
PCO2, m (±S) | 29 (7.5) | 26.3 (7.9) | 30.4 (7.2) | 30.3 (6.8) | 0.09 |
Lactate, m (±S) | 1.41 (0.6) | 1.45 (0.7) | 1.2 (0.6) | 1.5 (0.6) | 0.31 |
Hb, m (±S) | 13.5 (2.9) | 13.6 (3) | 13.1 (3) | 13.7 (2.8) | 0.63 |
Leukocytes, m (±S) | 10 (4.4) | 9.6 (3.5) | 10.3(5.1) | 10.1 (4.5) | 0.92 |
Neutrophils, m (±S) | 8 (4.1) | 7.7 (3.4) | 8.4 (4.8) | 7.8 (4.1) | 0.82 |
Lymphocytes, m (±S) | 1.3 (0.6) | 1.3 (0.54) | 1.2 (0.6) | 1.4 (0.7) | 0.4 |
Platelets, m (±S) | 254 (104) | 250 (91) | 261 (100) | 251 (119) | 0.9 |
Creatinine, m (±S) | 1.48 (2.8) | 0.95 (0.7) | 1.6 (3.3) | 1.8 (3.4) | 0.81 |
LDH, m (±S) | 394 (158) | 394 (189) | 369 (123) | 394 (158) | 0.19 |
D-Dimer, m (±S) | 1618 (1442) | 1593 (1845) | 1872 (1137) | 1380 (1268) | 0.01 |
Fibrinogen, m (±S) | 441 (247) | 439 (249) | 473 (250) | 413 (244) | 0.53 |
CRP, m (±S) | 117 (136) | 171 (122) | 187 (126) | 172 (158) | 0.67 |
Ferritin, m (±S) | 721 (927) | 669 (667) | 902 (1125) | 592 (910) | 0.35 |
D Bilirubin, m (±S) | 0.64 (1.6) | 0.91 (2.9) | 0.53 (0.5) | 0.5 (0.6) | 0.56 |
Troponin, m (±S) | 0.05 (0.2) | 0.1 (0.3) | 0.03 (0.08) | 0.02 (0.02) | 0.18 |
Variables | Entire Group (n = 106) | Hydroxychloroquine (n = 33) | Ivermectin (n = 36) | Placebo (n = 37) | p |
---|---|---|---|---|---|
N/L Index ≥ 3, n (%) | 89 (77.7) | 30 (90.9) | 31 (86.1) | 28 (77.7) | 0.34 |
SOFA, m (S) | 3.3 (1.6) | 3.1 (1.5) | 2.9 (1.5) | 3.8 (1.7) | 0.05 |
SOFA < 2, n (%) | 7 (6.6) | 2 (6.1) | 4 (11.1) | 1(2.7) | 0.33 |
2–3, n (%) | 61 (57.6) | 21 (63.6) | 22 (61.1) | 18 (48.6) | 0.38 |
≥4, n (%) | 38 (35.8) | 10 (30.3) | 10 (27.7) | 18 (48.6) | 0.14 |
APACHE II, m (±S) | 11.2 (4) | 11.1 (3.8) | 10.6 (3.7) | 11.9 (4.4) | 0.38 |
8–15, n (%) | 67 (63.2) | 22 (66.6) | 23 (63.8) | 22 (59.4) | 0.14 |
>15, n (%) | 23 (21.2) | 7 (21.2) | 5 (13.8) | 11 (21.7) | 0.25 |
CURB65, m (±S) | 1.08 (1.03) | 0.9 (0.9) | 1.1 (1) | 1.1 (1.1) | 0.77 |
≥2, n (%) | 37 (34.9) | 11 (33.3) | 14 (38.8) | 12 (32.4) | 0.82 |
Variables, n (%) | Entire Group (n = 106) | Hydroxychloroquine (n = 33) | Ivermectin (n = 36) | Placebo (n = 37) | p |
---|---|---|---|---|---|
Antibiotic | 56 (52.8) | 15 (45.4) | 23 (63.8) | 18 (52.8) | 0.25 |
Cephalosporines | 35 (33) | 11 (33) | 15 (41.6) | 9 (24.3) | 0.28 |
Macrolides | 17 (16) | 5 (15.1) | 7 (19.4) | 5 (15.5) | 0.77 |
Quinolones | 10 (9.4) | 2 (6) | 3 (8.3) | 5 (13.5) | 0.54 |
Piperacillin Tazobactam | 5 (4.7) | 0 | 3 (8.3) | 2 (5.4) | 0.25 |
Carbapenems | 10 (9.4) | 2 (6) | 6 (16.6) | 2 (5.4) | 0.18 |
Thromboprophylaxis | 101 (92.2) | 30 (90.9) | 36 (100) | 35 (94.5) | 0.19 |
Steroids | 61 (57.5) | 21 (63.6) | 21 (58.3) | 19 (51.3) | 0.6 |
Outcome | Entire Group (n = 106) | Hydroxychloroquine (n = 33) | Ivermectin (n = 36) | Placebo (n = 37) | p Value |
---|---|---|---|---|---|
Duration of hospitalization, med (IQR) | 6 (3–10) | 7 (3–9) | 6 (4–11) | 5 (4–7) | 0.43 |
Hospital discharge, n (%) | 96 (90.5) | 30 (90.9) | 32 (88.8) | 34 (91.8) | 0.91 |
Discharge without respiratory deterioration or death, n (%) | 80 (75.4) | 26 (78.7) | 27 (75) | 27 (72.9) | 0.85 |
Respiratory deterioration or death, n (%) | 23 (21.7) | 6 (18.1) | 8 (22.2) | 9 (24.3) | 0.83 |
Death, n (%) | 13 (12.2) | 2 (6) | 5 (13.8) | 6 (16.2) | 0.42 |
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Beltran Gonzalez, J.L.; González Gámez, M.; Mendoza Enciso, E.A.; Esparza Maldonado, R.J.; Hernández Palacios, D.; Dueñas Campos, S.; Robles, I.O.; Macías Guzmán, M.J.; García Díaz, A.L.; Gutiérrez Peña, C.M.; et al. Efficacy and Safety of Ivermectin and Hydroxychloroquine in Patients with Severe COVID-19: A Randomized Controlled Trial. Infect. Dis. Rep. 2022, 14, 160-168. https://doi.org/10.3390/idr14020020
Beltran Gonzalez JL, González Gámez M, Mendoza Enciso EA, Esparza Maldonado RJ, Hernández Palacios D, Dueñas Campos S, Robles IO, Macías Guzmán MJ, García Díaz AL, Gutiérrez Peña CM, et al. Efficacy and Safety of Ivermectin and Hydroxychloroquine in Patients with Severe COVID-19: A Randomized Controlled Trial. Infectious Disease Reports. 2022; 14(2):160-168. https://doi.org/10.3390/idr14020020
Chicago/Turabian StyleBeltran Gonzalez, Jose Lenin, Mario González Gámez, Emanuel Antonio Mendoza Enciso, Ramiro Josue Esparza Maldonado, Daniel Hernández Palacios, Samuel Dueñas Campos, Itzel Ovalle Robles, Mariana Jocelyn Macías Guzmán, Andrea Lucia García Díaz, César Mauricio Gutiérrez Peña, and et al. 2022. "Efficacy and Safety of Ivermectin and Hydroxychloroquine in Patients with Severe COVID-19: A Randomized Controlled Trial" Infectious Disease Reports 14, no. 2: 160-168. https://doi.org/10.3390/idr14020020
APA StyleBeltran Gonzalez, J. L., González Gámez, M., Mendoza Enciso, E. A., Esparza Maldonado, R. J., Hernández Palacios, D., Dueñas Campos, S., Robles, I. O., Macías Guzmán, M. J., García Díaz, A. L., Gutiérrez Peña, C. M., Martinez Medina, L., Monroy Colin, V. A., & Arreola Guerra, J. M. (2022). Efficacy and Safety of Ivermectin and Hydroxychloroquine in Patients with Severe COVID-19: A Randomized Controlled Trial. Infectious Disease Reports, 14(2), 160-168. https://doi.org/10.3390/idr14020020