From the onset of the Covid-19 pandemic I have cautioned against the use of unproven treatments for this terrifying disease. It is embedded in human nature, especially in times of crisis and uncertainty, to attempt home grown cures and remedies for ailments, and, as can be predicted, these treatments may work, or not. Interwoven in this dynamic, one may find placebo effects, which should not be discarded in medical terms. My maternal grandmother believed fervently, that crushed canna (Canna indica) leaves, used as a cold compress on the forehead, relieved headaches. Much to my long-suffering grandfather’s relief, this worked for her.
This brings me to the subject of Ivermectin as a cure or treatment for Covid-19. A scientific paper was published on Friday in a prestigious medical forum, BMC (British Medical Council) and here are the salient findings:
Current evidence regarding the efficacy of ivermectin for the treatment of COVID-19 patients is still unclear, and the WHO recommends its use only for clinical studies. Therefore, the aim of this study is to evaluate the efficacy of ivermectin in preventing hospitalizations in patients with COVID-19 (IVERCORCOVID19).
A randomized, double-blind, placebo-controlled study was conducted in the community between August 19, 2020 and February 22, 2021 in the province of Corrientes, Argentina.
Randomization was performed by one of the investigators through the web-based system using randomly permuted blocks in a 1:1 ratio (Supplementary Appendix). The investigator who performed the randomization was not involved in the dispensing of the medication, inclusion, and follow-up of the patients. The rest of the investigators were blinded to the treatment received, as were the patients. Patients were consecutively assigned to the treatment kit in ascending order at inclusion.
The primary outcome was hospitalization for any reason of patients with COVID-19. This was defined as a stay of at least 24 hours in a health institution, in any of its services, at any point from randomization until the end of study visit.
5 Statistical methods
To calculate the sample size, it was assumed that 10% of the patients required hospitalization, applying a statistical significance level of 0.05 and with a statistical power of 80%. When the trial was designed, there was not enough evidence of the potential benefit of ivermectin in these patients, therefore calculations were based on an estimated odds ratio in the ivermectin arm between 0.3 and 0.5 with the aim of including a total of 500 patients (250 patients in each group).
6 The results
During the study period, 22,533 SARS-CoV2 positive cases were evaluated for eligibility, of which 501 patients were included. Two hundred and fifty patients were randomized to ivermectin and 251 to placebo. In the ivermectin group, 249 patients had 100% compliance and 1 had 50% compliance. In the placebo group, 248 patients had 100% compliance, 2 patients had 50% compliance and 1 patient had 0% compliance. Considering that an intention-to-treat analysis was performed, all 501 patients were included for the analysis of primary and secondary outcomes. There were no arm crossovers.
Of all the individuals who participated in the study, 35 (6.99%) required hospitalization at any point from randomization to their end of study visit. Of these, 14 (5.60%) belonged to the ivermectin group and 21 (8.37%) to the placebo group. There were no statistically significant differences between the two groups [odds ratio 0.65; 95%CI, 0.32–1.31; p = 0.227]
7 Important findings
- As for mortality, there were no significant differences between the two groups.
- In the IVERCORCOVID19 trial, in patients with a positive COVID-19 nasal swab by RT-PCR technique in the last 48 hours, ivermectin in a staggered dose according to the patient’s weight for 2 days had no significant effect on preventing hospitalization of patients with COVID-19
- Patients who received ivermectin required invasive mechanical ventilatory support earlier.
I urge readers of this forum to read this study with care, and with attention. It is your democratic and constitutional right to apply any treatment as preventative, or as a cure for any ailment, since the world is awash with countless remedies and therapies for every known medical condition. It is, however, reckless to spread unfounded and possibly false information regarding public health, especially in dealing with a global pandemic.