Summary: Camostat mesylate, an oral medication commonly prescribed to treat pancreatitis, reduces both the loss of smell and taste in those with COVID-19 infection.
Source: Yale
Loss of smell and taste—a hallmark symptom of COVID-19—was not on the minds of a group of Yale School of Medicine researchers when they embarked on a study in the spring of 2020.
The scientists, led by Joseph Vinetz, MD, an infectious diseases specialist, were interested to find out if an oral medication used to treat pancreatitis could reduce the viral load (the amount of virus in your body) of SARS-CoV-2 and improve symptoms in people newly diagnosed with COVID-19.
The study, which is available on a preprint site and has not yet been published in a peer-reviewed journal, ran from June 2020 to April 2021. It showed that the medication, called camostat mesylate, did little to lessen viral load. But, to the researchers’ surprise, it brought a different type of benefit.
“The patients who received the drug didn’t lose any sense of smell or taste. That was a ‘wow’ factor,” says Dr. Vinetz.
This matters because loss of smell, known as anosmia, and loss of taste are common COVID-19 symptoms. For many, the senses return as the infection fades. But for others, the effect lingers in varying degrees. (With the omicron variant, those symptoms can still occur, but not as often as it has with other variants.)
How the ‘surprise’ finding on loss of taste and smell was discovered
Dr. Vinetz says he was originally motivated to look into camostat mesylate after he saw an April 2020 study published in Cell that showed how this medicine could prevent SARS-CoV-2 from entering cells.
Dr. Vinetz recruited several colleagues to collaborate, including Anne Spichler Moffarah, MD, Ph.D., an infectious diseases specialist, and Gary Desir, MD, chair of the Department of Internal Medicine. Geoffrey Chupp, MD, director of the Yale Center for Asthma and Airways Disease, ran the clinical trial.
The Phase II randomized trial enrolled 70 participants who tested positive for COVID-19 within three days of starting the study. Participants took the medicine four times a day for seven days.
Although the trial was stopped once it was clear that the main objective of reducing viral load was not occurring, the researchers think the surprise findings about loss of smell and taste warrant additional study.
“My daughter had COVID a year ago and she still has trouble smelling and tasting things,” says Dr. Desir. “This drug seems to be able to modulate that loss of smell and taste. It has very few side effects and has been studied extensively. This could be the type of treatment that is given to someone with COVID at the onset of the infection.”
If the drug were to be approved for this purpose, the doctors believe it could be a game-changer. “It wouldn’t be an expensive medication. Our idea was that everyone would take it if they were diagnosed because it’s hard to predict who will lose their sense of smell or taste, and it’s better to prevent it than to wait for it to happen,” Dr. Desir says.
Additional benefits found for those with COVID-19
There were also other benefits to this medication, as the study showed that those who received it reported notable improvements related to fatigue, compared to those who received a placebo.
“People who got camostat mesylate in the trial started feeling less tired and better overall after day four, which was statistically different from the placebo group,” Dr. Vinetz says.
“And there were essentially no adverse effects in the camostat mesylate group.”
Whether camostat mesylate could help restore sense of taste or smell in someone who has lost it is unknown, he adds. “More studies would help us with that,” Dr. Chupp says.
In order for camostat mesylate to become available for use in preventing the COVID-19-related loss of taste or smell, there would need to be a Phase III clinical trial and an application filed to the Food and Drug Administration (FDA) for emergency use authorization. All of this would take some time, Dr. Chupp explains.
Still, the doctors are hopeful their surprise discovery can make a positive impact on the fight against COVID-19. “A drug such as camostat mesylate presents an opportunity,” says Dr. Chupp
About this COVID-19 research news
Author: Carrie MacMillan
Source: Yale
Contact: Carrie MacMillan – Yale
Image: The image is in the public domain
Original Research: Closed access (pre-print).
“A Phase 2 Randomized, Double-Blind, Placebo-controlled Trial of Oral Camostat Mesylate for Early Treatment of COVID-19 Outpatients Showed Shorter Illness Course and Attenuation of Loss of Smell and Taste” by Joseph Vinetz et al. MedRxiv
Abstract
A Phase 2 Randomized, Double-Blind, Placebo-controlled Trial of Oral Camostat Mesylate for Early Treatment of COVID-19 Outpatients Showed Shorter Illness Course and Attenuation of Loss of Smell and Taste
Importance
Early treatment of mild SARS-CoV-2 infection might lower the risk of clinical deterioration in COVID-19.
Objective
To determine whether oral camostat mesylate would reduce upper respiratory SARS-CoV-2 viral load in newly diagnosed outpatients with mild COVID-19, and would lead to improvement in COVID-19 symptoms.
Design
From June, 2020 to April, 2021, we conducted a randomized, double-blind, placebo-controlled phase 2 trial.
Setting
Single site, academic medical center, outpatient setting in Connecticut, USA.
Participants
Of 568 COVID-19 positive potential adult participants diagnosed within 3 days of study entry and assessed for eligibility, 70 were randomized and 498 were excluded (198 did not meet eligibility criteria, 37 were not interested, 265 were excluded for unknown or other reasons). The primary inclusion criteria were a positive SARS-CoV-2 nucleic acid amplification result in adults within 3 days of screening regardless of COVID-19 symptoms.
Intervention
Treatment was 7 days of oral camostat mesylate, 200 mg po four times a day, or placebo.
Main Outcomes and Measures
The primary outcome was reduction of 4-day log10 nasopharyngeal swab viral load by 0.5 log10 compared to placebo. The main prespecified secondary outcome was reduction in symptom scores as measured by a quantitative Likert scale instrument, Flu-PRO-Plus modified to measure changes in smell/taste measured using FLU-PRO-Plus.
Results
Participants receiving camostat had statistically significant lower quantitative symptom scores (FLU-Pro-Plus) at day 6, accelerated overall symptom resolution and notably improved taste/smell, and fatigue beginning at onset of intervention in the camostat mesylate group compared to placebo. Intention-to-treat analysis demonstrated that camostat mesylate was not associated with a reduction in 4-day log10 NP viral load compared to placebo.
Conclusions and relevance
The camostat group had more rapid resolution of COVID-19 symptoms and amelioration of the loss of taste and smell. Camostat compared to placebo was not associated with reduction in nasopharyngeal SARS-COV-2 viral load. Additional clinical trials are warranted to validate the role of camostat mesylate on SARS-CoV-2 infection in the treatment of mild COVID-19.
Trial registration: Clinicaltrials.gov, NCT04353284 (04/20/20) (https://clinicaltrials.gov/ct2/show/NCT04353284?term=camostat+%2C+yale&draw=2&rank=1)
