Argentina Ministry of Public Health Completes IVER-Leve Ivermectin Study: Results Show Clinical Benefit

Argentina Ministry of Public Health Completes IVER-Leve Ivermectin Study Results Show Clinical Benefit

Researchers led by the Ministry of Public Health Tucumán, Argentina, recently completed the IVER-Leve clinical trial, organized in response to the challenges with the COVID-19 emergency, accentuated by high demand for vaccines as well as the imminent urgency of finding treatment based on reuse of existing drugs to prevent the progression of the disease. The study aimed to determine if ivermectin in mild-stage patients served to boost outpatient discharge and prevent the progression of the contagion to moderate and more severe stages. The net result of this 254 participant study indicates that the ivermectin study group benefited over the control group. Not one COVID-19 patient was hospitalized, for example.

The Study

This study (NCT04784481) sponsored by the Ministry of Public Health, Argentina, aimed to evaluate the use of the anti-parasite drug in mild stage patients to boost outpatient discharge while preventing disease progression to moderate or severe stages.

Led by Rossana E. Chahla, MD, PhD,  the study also sought to add value finding that an intervention with ivermectin can possibly impact PPS in a population of outpatients, between the 5th and 9th day. Does the treatment boost the probability to obtain outpatient discharge, even if the subject has comorbidities?

Recently uploaded to Research Square, the authors report that the study involved 254 total participants (subjects) and that two groups included 1) an experimental group (n=110) and 2) a control group (n=144). The experimental group received ivermectin orally administered in the form of 4 tablets of 6mg equaling 24 mg every 7 days for four (4) weeks.

Using proportion, bivariate and logistic regression, the team established a P-value significance at p<0.05. Both groups were similar in age, sex, and comorbidities. Median age was 40 and ranged from 18 to 75 with 11% females. While the median age of the control group was 36 with ages ranging from 18 to 71—57.89% of this group was female. 

Findings

The group found that material reduction in the proportion of subjects with symptoms (PPS) in both groups when the study team evaluated symptoms from the 5th to 9th study day (p=0.0005). By the 10th to 14th days, there was no statistical difference. The experimental group (ivermectin) was discharged at  higher rate than the control group coming in at 98.2% vs. 86.1% respectively with a p-value of 0.0007.

Interestingly, the group that was administered ivermectin (experimental group) had 8 times more probability of discharge than the control group (8·71 CI = [1·99, 38·12]; p = 0·004).

Conclusion

The study team declared that those patients with mild COVID-19 treated with ivermectin did in fact manage to slightly reduce PPS—that is, the percentage of participants with symptoms. Moreover, the treatment did improve the ivermectin group’s clinical state supporting outpatient discharge, even in correlation to comorbidities. The author’s declared that “The treatment with ivermectin could significantly prevent the evolution to serious stages since the experimental group (EG) did not present any patient with referral to critical hospitalization.” This means not one patient in the group administered ivermectin became ill enough to go to the hospital.

Sponsor Qualifier

While the sponsor acknowledges that the effort to establish medical evidence isn’t easy, taking many adequately powered, well-designed studies, they articulate herein that this study demonstrates similar benefits to other ivermectin studies, and thus in the aggregate suggest “encouraging,” data suggesting more study for repurposing ivermectin.

The Sponsor

This study was sponsored by the Ministry of Public Health, Argentina. This ministry represents the national executive power overseeing, managing, and coordinating the Argentine national state’s public health policy. They oversee Argentina’s decentralized universal health care system, which purportedly serves about half of the population

Lead Research/Investigator

Rossana E. Chahla, MD, PhD

Call to Action: This represents yet another study demonstrating positive ivermectin influence in various formal clinical studies, in this case from one sponsored by the Ministry of Public Health, Argentina.

Responses

  1. How many of the non-ivermectin group required hospitalization, and was it statistically different from the zero in the ivermectin group?
    With the huge difference in proportion of women in the groups (11% vs. 58%) this is clearly not a randomized study.
    How soon after the onset of symptoms was the study drug begun? Was there a limit? Did the drug need to be started within X days of symptom onset?
    If given later than about day 5 of symptoms, it will have less of an impact, because viral replication has slowed down a lot by day 6 and you’ll have left mostly the immune and inflammatory modulating effects of the drug.

  2. As I’m not a biostatistician or pharmacological researcher I’m probably missing something — but, this study does not appear to have produced the sort of mind-blowing results that one would expect from the hoopla surrounding Ivermectin.
    If someone with the requisite expertise would dissect the study, I think it would be very helpful for everyone who’s interested in this subject.