Source: Trial Site news
A recent study sponsored by the Ministry of Health of Argentina sought to evaluate the use of ivermectin in mild stage outpatients to heal and /or reverse the progression of COVID-19 disease towards the development of moderate or severe stages.
The premise behind this government-sponsored study was that the emergence of COVID-19 requires alternative treatments based on the reuse of drugs as a strategy to prevent the progression of the disease in patients infected with SARS-CoV-2.
The sponsor designed a cluster assigned clinical trial (2:1) in outpatients with a total of 234. The subjects were divided into experimental (110) and control groups (62), with the experimental group receiving orally 4 drops of 6mg (24) mg every 7 days for 4 weeks.
The study team concluded that a significant reduction in the symptom numbers was observed in the experimental group when medical examination was conducted from 5th to 9th days, after commencing treatment (p=0.0026). Past the 10th and 14th days, the investigators observed a progressive reduction of the percentage of symptom numbers, however they were not significant in both groups.
The study sponsors concluded as well that those in the experimental (ivermectin) group represented a higher proportion of medical release (98.2%) versus the control group (87.1%) at p=0.003. In fact, the ivermectin group was eight (8) times as likely to receive medical release than the control group (OR 7.99, 95% Cl: 1.64-38.97, p=0.003).
To conclude, the authors suggest treatment with ivermectin in outpatients with mild stage COVID-19 managed to slightly reduce the symptom numbers. Also, this treatment improved the clinical state to obtain medical release, even in the presence of comorbidities. The treatment with ivermectin could significantly prevent the evolution to serious stages since the experimental group did not present any patient with referral to critical hospitalization.
This study was recently uploaded to medXriv and isn’t yet peer reviewed.
This study (NCT04784481) was organized by the Ministry of Health in Argentina to test the efficacy of ivermectin as an alternative treatment based on the reuse of drugs as a strategy to prevent progression of the disease. This particular study centered on the use of ivermectin in mild-stage outpatients to heal and/or reverse the progression of COVID-19 disease from progressing to moderate or severe stages.
With a target of n=234, the subjects were divided into experimental groups (ivermectin) and control groups. The experimental group received ivermectin orally, 4 drops of 6mg (24mg) 7 days for 4 weeks. All participants were evaluated by physical evaluation and had to be positive for COVID via RT-PCR at the beginning, and end of the protocol.
The study team concluded that the treatment with ivermectin in the population of outpatients with mild stage COVID-19 disease managed to significantly reduce the number of symptoms on days 5 and days 9. However, by 10 day onward, subsequent medical examinations didn’t reveal statistical differences.
Ivermectin had a significant effect (p=0.003) in achieving medical release. The treatment with ivermectin could significantly prevent the evolution to serious stages since the experimental group did not present any patient with referral to critical hospitalization.
In other groups, the patients did not advance to highest scores in the ordinal scale, which represents more compromised stages of the disease. Apparently, the Argentinian study group reports that ivermectin brought other benefits in relation to the improvement in the patient’s condition.
There were no adverse events reported.
Those patients on ivermectin had a greater than 89.1% probability of being released at the end of the intervention than did the control group (on placebo). This probability existed even when factoring the presence of comorbidities.
No deaths were recorded in either group of these mild COVID-19 patients. The median age of study participants (40) as well as comorbidities were equally present in both groups.
· Maria Peral de Bruno, Ph.D. Health Research Institute, Ministry of Health.
· Chahla, Rossana Elena Head SI.PRO.SA (Province Health System), Ministry of Health, Tucumán, Argentina.
· Medina Ruiz, Luis President of the Medical Executive Secretary, SI.PRO.SA Tucumán, Argentina.
· Teresa Mena Primary Care service network, Ministry of Health, SI.PRO.SA, Tucumán, Argentina
· Yolanda Brepe Primary Care service network, Ministry of Health, SI.PRO.SA, Tucumán, Argentina
· Paola Terranova Primary Care service network, Ministry of Health, SI.PRO.SA, Tucumán, Argentina
· Ortega, Eugenia Silvana Health Research Institute, Ministry of Health, SI.PRO.SA, Tucumán, Argentina
· Barrenechea, Guillermo Gabriel Health Research Institute, Ministry of Health, SI.PRO.SA, Tucumán, Argentina.
· Goroso, Daniel Gustavo Research and Technology Center, Mogi das Cruzes University, Brazil. Human Motor Skill Analysis Laboratory, National University of Tucumán, Tucumán, Argentina.
· Peral de Bruno, Maria de los Angeles* Health Research Institute, Ministry of Health, SI.PRO.SA, Tucumán, Argentina