Applying symptom tracking to COVID-19 outpatient care using famotidine


Date:
June 5, 2020
Source:
Cold Spring Harbor Laboratory
Summary:
A patient-reported symptom tracking method used for patients with
cancer has now been adapted for patients with COVID-19. The first
clinical case series showed that famotidine may help COVID-19
patients with mild to moderately severe symptoms.



FULL STORY ==========================================================================
A patient-reported symptom tracking method used for patients with cancer
has now been adapted for patients with COVID-19. Investigating the effect
of famotidine, a potential treatment for COVID-19, on non-hospitalized
patients with COVID-19, clinicians at Northwell Health and cancer
researchers at Cold Spring Harbor Laboratory (CSHL) developed the method
to use in addition to laboratory tests. This outpatient approach addresses
the need to care for the majority of COVID-19 patients who do not require hospitalization. The first clinical case series showed that famotidine may
help patients with mild to moderately severe symptoms from COVID-19. Next,
the team will test the drug in a randomized clinical trial.


========================================================================== Published in the journal GUT, the Northwell-CSHL case series is unique
in its adaptation of quantitative tracking of patient-reported outcome measures. The methodology is suitable for testing drugs in patients well
enough to be managed at home and allows the recruitment of diverse
subjects via community-based health organizations and individual
practitioners.

The lead author of the study, CSHL Assistant Professor Tobias Janowitz,
is a Medical Oncologist and a Cancer Researcher, who investigates the whole-body causes and effects of diseases. "The experience of a patient
at one point in time is very valuable, but learning about the change in
their experience over time is even more important," says Janowitz. "Change indicates if the patients' condition is getting better or worse. A graded symptom score enables the physician and the patient to track symptoms
using numbers." Observing that for COVID-19, most symptomatic people
do not require hospitalization, Janowitz and colleagues developed a
4-point scale for six common COVID-19 associated symptoms that patients
score every day. Janowitz simplifies how the scale can help track the
course of a patient's disease: "You may call up your doctor and say,
I have headaches and shortness of breath, and am only able to do the
basics for self-care, which would be grade 3 symptoms. If you still had
the symptoms two days later, but are now able to do light work, these
symptoms would now be scored at grade 2. This approach makes it very easy
for you and your doctor to document that your symptoms are improving. The
value of this approach from a research perspective is that experiences
from many patients become comparable and can be pooled for analysis."
If a drug speeds recovery, then most patients will report more rapid improvement of symptoms.



==========================================================================
The innovations in this study are the product of scientists and
physicians who never expected to work on a pandemic infection. But
the collaborative, multidisciplinary approach is a hallmark of the
strategic research affiliation between CSHL and the academic physicians
at Northwell Health. Chief, General Internal Medicine, Northwell Health
and Professor at the Feinstein Institutes, and a co-author on the
study, Joseph Conigliaro says: "There are a lot of things that we were
doing that worked well in how we address this pandemic. I'm a health
services addiction researcher. I didn't think I'd ever be the person
who would be studying this pandemic and this virus. And Tobias does
cancer research. What we did is we used our existing tools and talents
that were not specifically geared towards studying a viral pandemic,
but we used it and modified it in ways that were very, very helpful."
CSHL Professor David Tuveson, Director of the CSHL Cancer Center and
another co-author, is interested in the broader implications of the patient-oriented research approach as a way to better connect science
and healthcare. CSHL's commitment to bridging the gap between research
and the clinic is evident in an initiative championed by Janowitz to
study how disease impacts the entire body.

Tuveson says: "You're trying to scientifically assess a symptom, is what
you're really doing.

Tobias and his colleagues can look at the whole body while they study
cancer.

And so Tobias is someone who thinks about the big picture of health. He's basically shifting his approach to solving complex problems to COVID-19
and he started by saying 'how can we describe one patient relative to
the next?'" Janowitz agrees, "It seems reasonable to me to make that
extension to this healthcare crisis and to acknowledge that we can learn
a lot from the individual who has the disease as long as we find a way
to make it quantifiable." Once validated, the patient-reported symptom tracking method will be a key component in a clinical trial that is "double-blind," meaning that neither patient nor doctor know whether
the patient is getting the test drug or a placebo until the trial is
completed. Without a double-blind clinical trial and a careful scientific examination of the mechanism of action of a drug and its side effects,
it is impossible to rule out that the preliminary findings were due to
factors other than the drug. The early findings of this case series were communicated to co-author Dr. Timothy Wang at Columbia University Medical Center. Interestingly, Dr. Wang and colleagues were also able to find an association between famotidine usage and the improved outcomes of patients hospitalized for COVID-19. Based on the findings in the case series, a
double- blind clinical trial of famotidine is the next step in the joint
plan of the Northwell-CSHL team. Other treatments may also be explored.

Conigliaro explains why he is hopeful that the study will work as designed
to find drugs that will be effective against COVID-19: "We had about a
thousand patients that we tracked in our practices, just in my couple
of academic practices, that never made it to the hospital. And my Doc's
were calling them every day and asking all those questions: 'Do you have
aches and pains? Do you have fever today? How's your breathing today?' We didn't know what their blood levels were. We didn't know what their
oxygen levels, because we didn't have access to that. So these surrogate measures are very common and the best way to assess what's going on
in the outpatient. I'm actually pretty confident. I think there'll be
another surge but I think we'll be much better prepared and I think that hopefully lives will be saved."

========================================================================== Story Source: Materials provided by
Cold_Spring_Harbor_Laboratory. Original written by Eliene
Augenbraun. Note: Content may be edited for style and length.


========================================================================== Journal Reference:
1. Tobias Janowitz, Eva Gablenz, David Pattinson, Timothy C Wang,
Joseph
Conigliaro, Kevin Tracey, David Tuveson. Famotidine use and
quantitative symptom tracking for COVID-19 in non-hospitalised
patients: a case series. Gut, 2020; gutjnl-2020-321852 DOI:
10.1136/gutjnl-2020-321852 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2020/06/200605004329.htm

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