Studies continue to show that ivermectin for COVID-19 treatment is ineffective
Studies continue to show that ivermectin for COVID-19 treatment is ineffective

Studies continue to show that ivermectin for COVID-19 treatment is ineffective

Since coronavirus disease 2019 (COVID-19) first appeared, healthcare professionals have been frustrated by the lack of effective treatments. Patients who develop into a serious illness receive supplemental oxygen or need invasive mechanical ventilation, but early on, very few drugs can help infected individuals.

Examination: Effect of Ivermectin treatment on disease progression in adults with mild to moderate COVID-19 and comorbidity. Image credit: Carl DMaster / Shutterstock

Unfortunately, there have been constant rumors about drugs that later prove to be ineffective – hydrochloroquine received significant media attention. Researchers from hospitals around Malaysia have studied the effectiveness of the controversial drug ivermectin.

The study

High-risk patients were enrolled in the randomized clinical trial at 20 different public hospitals across Malaysia, including a COVID-19 quarantine center. As all COVID-19 cases in Malaysia must be reported to the health authorities, patients at risk of developing serious illness are referred to hospital or quarantine centers for closer monitoring. These patients were then included in the study if they met certain criteria, including a positive reverse transcriptase polymerase chain reaction (RT-PCR) test, at least one comorbidity, and if they were at least 50 years old. Asymptomatic patients and those who had developed to the point where they needed supplemental oxygen or showed other signs of serious disease risk were excluded, as were those who had taken drugs reported to be effective against COVID-19 in the last seven days.

Following randomization, patients in the ivermectin group received 0.4 mg / kg ivermectin for five days, calculated to the nearest 6 mg or 12 mg full tablet dose. This was administered with or after food. The primary outcome examined was the progression to serious illness – which was determined to be the point at which the patient needed supplemental oxygen, but other factors were also examined, including the time of progression to serious illness, mortality rates, hospitalization in intensive care units, and the frequency of Unwanted and serious side effects, among others.

Statistical analysis was performed to determine any effect or danger for patients after administration, with sensitivity analyzes for all patients. Mean values ​​and standard deviations were used for descriptive data, while categorical data were analyzed using Fisher exact tests and continuous variables tested using either the t-test or the Mann-Whitney U-test. Risk factors were used to estimate primary and categorical secondary outcomes.

The study included a total of 500 patients, examined between May and October 2021. After randomization, four patients were excluded due to failure to meet inclusion criteria or extensive comorbidities such as dengue co-infection and acute coronary syndrome. Another six patients withdrew their consent. Out of the 490 remaining patients, 249 were enrolled in the control group and 241 received doses of ivermectin. 232 of these completed all five doses. The mean age of the participants was 62.5 years, and men and women were roughly equally represented. 51.8% of patients were fully vaccinated. Many had comorbidities, including hypertension, diabetes, and obesity.

Out of the 490 patients included in the final analysis, 95 developed into serious illness during the study. 52 of these had received the standard treatment as well as ivermectin, and 43 had received the standard treatment. As these figures suggest, statistical analysis showed no significant differences between ivermectin and control groups, and this trend continued when examining secondary outcomes. In patients who developed into severe disease, it took 3.2 days for the ivermecting groups to develop into severe disease compared to 2.9 for the control groups. There were also no significant differences between the groups when examining mechanical ventilation and intensive care unit admission. 28-day mortality was also very similar for both groups, as was the average length of hospital stays. Finally, the pathology for both groups showed no clear differences.

When the researchers examined adverse events, the researchers found that 55 had occurred in 44 different patients – a frequency of 9%. 33 of these patients were from the ivermectin group. Most were relatively mild, but five events were serious adverse events, including severe anemia, hypovolemic shock, and two myocardial infarctions in the ivermecting group. Only one serious adverse event occurred in the control group – the patient suffered from inferior epigastric arterial bleeding. While there were a total of 13 deaths, none of these were attributed to ivermectin treatment.

Conclusion

The research has not found evidence of the efficacy of ivermectin in patients at risk of developing severe COVID-19. This is supported by several other studies that have not shown any effect on disease outcomes. While initial media attention to the drug has led many to believe that it may prevent disease, there have been very few studies showing any positive effect, and there is considerable controversy surrounding the robustness and replicability of these papers. Therefore, this study may allow researchers to focus on more promising graduates in the future.

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