BREAKING! COVID-19 Treatments: Second Observational Study Shows Famotidine Associated With Better Outcomes For Hospitalized COVID-19 Patients
: A second clinical observation study, this time conducted by researchers from Harford hospital-Connecticut have demonstrated that administering famotidine to hospitalized COVID-19 patients was associated with a reduction in death and a composite endpoint of either death or intubation. The study involved 878 hospitalized COVID-19 patients of which 83 (9.5%) received famotidine. The findings also demonstrated lower levels of serum markers for severe disease indicating that famotidine could prevent or treat disease severity.
The study findings were published in the American Journal of Gastroenterology. https://journals.lww.com/ajg/Documents/AJG-20-2074_R1.pdf
Lead researcher Jeffrey F. Mather, MS director of data management in the division of research management at Hartford Hospital, told Thailand Medical News, "The mechanism of exactly how famotidine works has yet to be proven. There's thought that it works directly on the virus, and there is thought that it works through inactivating certain proteases that are required for the virus infection, but I think the most interesting hypothesis is by Dr Robert W Malone who says that the drug possibly blocks the histamine-2 receptor causing a decrease in the amount of histamine. It's all speculative, but it will be interesting if that gets worked out."
Dr Robert W Malone study that involved researchers from Icahn School of Medicine, University Of North Carolina, Harvard Medical School. McGill University-Canada and a host of other entities propose that the principal famotidine mechanism of action for COVID-19 involves on-target histamine receptor H2 activity, and that development of clinical COVID-19 involves dysfunctional mast cell activation and histamine release. https://www.researchsquare.com/article/rs-30934/v1
Another earlier larger observational study led by Columbia University Irving Medical Center and New York Presbyterian Hospital, New York that involved 1620 COVID-1 patients with 84 patients (5.1%) who received famotidine within 24 hours of hospital admission showed reduced risk of clinical deterioration leading to intubation or death.https://www.sciencedirect.com/science/article/pii/S0016508520347065
In the recent study by Hartford Hospital-Connecticut, Mather and colleagues retrospectively evaluated 878 patients who tested positive for SARS-CoV-2 and who required admission between Feb. 24, 2020, and May 14, 2020.
COVID-19 patients were classified as receiving famotidine if they were treated with either oral or intravenous drug within 1 week of COVID-19 screening and/or hospital admission. Primary outcomes of interest were in-hospital death as recorded in the discharge of the patients, requirement for mechanical ventilation, and the composite of death or requirement for ventilation.
The key secondary outcomes of interest were several serum markers of disease activity including white blood cell count, lymphocyte count, and eosinophil count.
The drug f
amotidine was administered orally in 83% of the patients and intravenously in the remaining 17%. The study team Mr. Mather reported that 83 of the 878 patients studied (9.5%) received famotidine.
When compared with patients not treated with famotidine, those who received the drug were slightly younger (a mean of 64 vs. 68 years, respectively; P
= .021); otherwise, there were no differences between the two groups in baseline demographics or in preexisting comorbidities.
Significantly, the use of famotidine was associated with a decreased risk of in-hospital mortality (odds ratio, 0.37; P
= .021) as well as combined death or intubation (OR, 0.47; P
= .040). The outcomes were similar when the researchers performed propensity score matching to adjust for age differences between groups.
Furthermore, the use of famotidine was associated with lower levels of serum markers for severe disease including lower median peak C-reactive protein levels (9.4 vs. 12.7 mg/dL; P
=. 002), lower median procalcitonin levels (0.16 vs. 0.30 ng/mL; P
= .004), and a nonsignificant trend to lower median mean ferritin levels (797.5 vs. 964 ng/mL; P
Interestingly, logistic regression analysis revealed that use of famotidine was an independent predictor of both lower mortality and combined death/intubation. In addition, predictors of both adverse outcomes included older age, a body mass index of greater than 30 kg/m2, chronic kidney disease, the national early warning score, and a higher neutrophil-lymphocyte ratio.
Medical experts not involved with the study however cautioned, "This is an important stepping stone, but until we have a randomized, controlled trial, we really cannot speak about causation; we can only speak about association, and that's okay. There's nothing wrong with association because finding associations can raise important hypotheses that can then be tested in prospective randomized trials, for example."
Dr Brennan M.R. Spiegel from Cedars Sinai Medical Center-California and his colleagues published a separate research in July looking at proton pump inhibitors and the risk of COVID-19. https://journals.lww.com/ajg/Documents/AJG-20-1811_R1(PUBLISH%20AS%20WEBPART).pdf
He commented, "In that study we did look at H2 blockers, and we did find that they were slightly associated with a reduction in COVID-19. It was a small effect, but it was a benefit. When we see consistency among studies, it's a signal in the noise we can try and follow and see if there is something more to it."
The researchers in the current study acknowledged certain limitations of the study, including the fact that patients who did and did not receive famotidine were propensity-matched for age.
Mr Mather said, "The risk factors that others have shown for adverse events are equivalent in the groups, but anytime you do a retrospective study like this there is the potential for underlying factors that may play a role in the outcomes that you're not considering. That's why the gold standard is the randomized trial, to wash those effects out. There's only an association here, and it supports the need for a randomized trial."
Importantly Famotidine is currently being tested in a double-blind randomized clinical trial in combination with either hydroxychloroquine or remdesivir (NCT 04370262). Thailand Medical News will be providing updates on that.
Dr Spiegel, who is also co-editor in chief of the American Journal of Gastroenterology, "It's fascinating because famotidine is a safe medicine. There are very few side effects; it's something we've been using for decades."
To date there are still no proven drugs that are able to treat COVID-19 disease or its accompanying symptoms. Only two drugs have been given experimental status and or emergency use status ie remdesivir and dexamethasone.
Dexamethasone, a corticosteroid is only to reduce severity due to inflammatory factors and can only be used in hospitalized patients with severe conditions.
Remdesivir which was approved by the US FDA on questionable grounds only claims to be able to reduce hospitalization stays by a few days for severe COVID-19 patients. It does not show to improve mortality rates nor have any long term safety studies ever been done on it. Furthermore many frontline physicians are not questioning its effectiveness due to dismal performance coupled with the rather expensive price tag on it (ie between US$ 3200 to US$ 3700).
Famotidine is extremely cheap with the oral tablets less than US$1 per tablet.
There are also other cheaper drug candidates being explored including Ivermectin, Colchine, Niclosamide etc.
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