In this video, Dr. Seheult of MedCram discusses a study in the NEJM that compares ivermectin, fluvoxamine and metformin in outpatient COVID-19 treatment. This was a phase 3, randomized controlled study. The study looked at how these drugs could prevent hypoxemia, ER visits and hospitalization. This study was funded by the Parsemus Foundation.
Study participants
This study was primarily done in the United States with an entrance requirement of 30-85 years of age, overweight or obese category, diagnosed with COVID-19 within the last 3 days, and no more than 7 days of any symptoms. The study took place between 12/30/20 to 1/28/22 so it contained the different variant waves of alpha, delta and omicron. It recruited a total of 1431 patients and was powered to detect a 30-40% relative risk reduction in hospitalization, ER visits, and low oxygen saturation which was defined as less than 93%. The study then divided the remaining 1323 patients into different groups that received either metformin up to 1500 mg/day x 14 days, ivermectin dosed at 390-470 mcg/kg per day x 3 days, or fluvoxamine at 50 mg twice a day x 14 days. The participants were specifically randomized into 6 groups which included both drugs placebo, one placebo and one ivermectin, one placebo and one fluvoxamine, one placebo and metformin, metformin and ivermectin, metformin and fluvoxamine.
Results
The results of this study showed that none of the medications reached statistical significance in the primary composite endpoint. However, when looking at the end point for ER visits, hospitalization and/or death, metformin did reach statistical significance and did at least appear to be improve outcomes in obese/overweight patients. The overall conclusion was that metformin, ivermectin and fluvoxamine did not prevent severe COVID-19 outcomes in non-hospitalized patients with obesity or in the overweight category.
Limitations to the study
Limitations to this study, per the article, included it being limited to only patients between the age of 30 and 85 and to those who were overweight or obese in the United States. These findings may not be able to be generalizable to people outside of these parameters. There was also a smaller percentage of persons who identified themselves as Black or Latinx included in this study. Another limitation the authors acknowledged was that the hypoxemia component was subject to a bias as it was self reported and accuracy of the oximetry monitors at home could not be validated especially with nonprescription brands. Another bias was a recall bias as an emergency department visit or hospitalization could be influenced by a patient’s willingness to seek care. The most accurate and well documented end point however was hospitalization as objective criteria are needed for an admission.
This study did show some potential promise in using metformin in certain patients but future studies are needed to further elucidate that.
LINKS / REFERENCES:
Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19 (NEJM) | https://www.nejm.org/doi/full/10.1056…
Mission (Parsemus Foundation) | https://www.parsemus.org
Prevention Protocol (FLCCC) | https://covid19criticalcare.com/wp-co…
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