Category: Uncategorized

TGH, USF Health part of study aimed at re-purposing medications to treat mild to moderate COVID-19

ACTIV-6 study to look at ivermectin, fluticasone furoate, and fluvoxamine

Link to ABC Action News Original Article

By: Jillian Ramos

TAMPA, Fla. — Tampa General Hospital and USF Health are part of a nationwide study that is looking at older medications to treat COVID-19.

“So ACTIV-6 is for those re-purposed drugs that have at least enough evidence behind them that says there might be a signal here that can help somebody, but more importantly, everything that has been done with them so far, there’s really not a signal for harm. And so to make it into the ACTIV-6 group of drugs that might be used, re-purposed, you have to at least meet that level of safety and possible efficacy against NIH study. So that means the bar is very high. The bar is very high for making sure we’re doing the study,” explained Dr. Jason Wilson.

The study will look at drugs (ivermectin, fluticasone furoate, and fluvoxamine) to see their impact on the omicron variant of COVID-19. The drugs will be taken in an outpatient setting, which means you won’t have to leave your house. Right now, there are no FDA-approved drugs to treat mild to moderate symptoms of COVID-19, which this study hopes to look at.

“We’re looking just like with vaccines, to see if we can keep people out of the hospital, or keep people from dying from COVID. And that’s really about the ACTIV-6 studies looking at prevention of hospitalizations by using repurposed drugs,” explains Dr. Wilson

Here are the qualifications you have to meet once you test positive for COVID-19 to participate in the study:

  • At least 30 years old and not pregnant
  • Tested positive within 10 days
  • Have at least two symptoms for seven days or less
    • Fatigue, difficulty breathing, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, loss of taste or smell

Once you enter the study, drugs will be sent to your house the next day. You will take them for a few days and the medical team will follow up for a month at different intervals of time. The communication will be via phone calls/mail. The drugs are free and you will be compensated $100.

“So the way this trial is designed, is that we’re going to capture thousands of people throughout the country. And we’re going to do it fairly quickly because there’s so many different trial sites. And it’s important to note too, that with ACTIV-6 some sites came online earlier, and some are just ramping up, like us. So the ones who came on earlier had some good tests around the delta variant. And as we come along, we’re getting a good test on omicron. The data we’re going to get it’s going to be really powerful for looking at that. But with four arms, meaning placebo, fluvoxamine, ivermectin, fluticasone. We got to have a lot of people in there to get good samples. So we’re hoping to enroll well into the hundreds in this area, and in the 1000s, in the state of Florida,” explained Dr. Wilson.

Click here for more information on the ACTIV-6 study and to find out how to enroll.

USF, Tampa General Hospital join nationwide COVID treatment study

From Bay News 9. January 28, 2022.

The University of South Florida and Tampa General Hospital have joined onto a nationwide study to look at existing medications as possible treatments for COVID-19 infections. 

According to the ACTIV-6 study’s website, the Duke Clinical Research Institute coordinating the study along with Vanderbilt University Medical Center.

To be eligible for the study, an individual must be at least 30 years old, have tested positive for COVID-19 within the past 10 days and have at least two symptoms, including fatigue, difficulty breathing, fever, couch, and nausea, among others. 

ACTIV-6 is a nationwide double-blind study that is expected to eventually have nearly 15,000 participants. People can participate from any part of the United States via the study’s website or by calling 833-385-1880.

Medications currently being studies include fluvoxamine, a selective serotonin reuptake inhibitor; fluticasone, an inhaled steroid; and ivermectin, which is used to treat parasitic infections.

USF’s Dr. Jason Wilson said participants will not have to leave their homes to be a part of the study.

“If you decide to take part in our study, our team reaches out to you, we have a conversation and get you medicine delivered the next day to your house in the mail,” he said. “So, really all the encounters will happen by phone and by mail, and you’ll always have that research team available to answer your questions.”

OUTPATIENT TREATMENT OPTIONS FOR COVID-19. UPDATED JANUARY 28, 2022

  • ACTIV-6 Study
  • Paxlovid
  • MolnupiravirF
  • luvoxamine
  • Sotrovimab
  • Remdesvir
  • Epic Orders
  • Epic SmartPhrase
  • DOH Medication/Treatment Locator
  • Other supportive care treatment options

ACTIV-6 Outpatient Study for Repurposed Medications

  • Enroll at ACTIV6STUDY.ORG
  • The purpose of the ACTIV-6 research study is to test medications that are already approved for other diseases to see if they can help people with mild to moderate COVID-19 feel better faster and stay out of the hospital. ACTIV-6 is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program.
  • Patients are able to self-enroll in ACTIV-6 at activ6study.org
  • Patients that enroll in ACTIV-6 can still receive other outpatient therapies including Mabs, remdesvir, Paxlovid, and MolnupiravirACTIV-6 includes arms for fluvoaxmine, fluticasone, ivermectin, placebo
  • adults, Covid+ last 10 days, do not have to come in, do not have to have been seen at TGH/USF
  • There is a .ACTIV6 smart phrase with text from an IRB approved recruitment flier under the Epic User Name Wilson, Jason [18448]. That can be included in the AVS for the patient and used for reference

Nirmatrelvir+Ritonavir [Paxlovid]

  • Paxlovid can be found in Epic but requires you to search the database. Below are some screenshots for locating Paxlovid.
  • You can add it to your favorites when you order the medicine the first time.
  • You should then be able to find it easier the next time

Paxlovid CrCl > 60 ml/min

Paxlovid CrCl 31-60 ml/min

  • You can select the pharmacy during the ePrescribe process by clicking on the current pharmacy name (this example has TGH Outpatient Pharmacy).
  • TGH Outpatient Pharmacy does not have Paxlovid.
  • Only retail pharmacies have been supplied medication.

To find a pharmacy with Paxlovid, use this website:
HHS/DOH COVID TREATMENT LOCATOR (Monoclonals, Paxlovid, Other)

Information about Nirmatrelvir+Ritonavir [Paxlovid]

  • nirmatrelvir is a protease inhibitor that inhibits mPRO and stops viral replication EPIC-HR Trial (n=2,246).
  • 28 day hospitalization in Paxlovid arm 0.8% (n=8), 6.3% in placebo arm (n=66). Relative Risk Reduction = 88%, Absolute Risk Reduction = 5.5%, Number Needed to Treat to prevent 1 hospitalization on Paxlovid = 18
  • All cause 28 day mortality Paxlovid arm 0%, placebo arm 1.1% (n=12). RRR = 100%, ARR = 1.1%
  • Number needed to Treat to prevent 1 death on Paxlovid = 91
  • The EUA for Paxlovid can be found at this link
  • EUA allows for outpatient treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg)
  • no for PrEP or PEPstart within 5 days of symptom onset
  • RX: Take 3 pills in the morning (2 X 150mg nirmatrelvir, 1 X 100mg ritonavir) and 3 Pills in the evening (2 X 150mg nirmatrelvir, 1 X 100mg ritonavir)
  • 30 total pills dispensed in a dose pack for CrCl > 60 ml/min
  • If CrCl 31- 60 ml/min, there is decreased dosing (take 1 nirmatrelvir 150mg tablet in morning and night instead of 2) -> 20 total pills in CrCl 31-60
  • Avoid in patients with CrCl < 30 ml/min and hepatic impairment with Child-Pugh C
  • May want to avoid in patients with HIV
  • Caution if patient on drugs that reliant on CYP3A4 metabolism, especially if patient has decreased CrCl.Caution if on: statins, NOACs, warfarin, calcium channel blockers, anti-arrhythmics, HCV Direct Acting Antivirals, sofosbuvir, alfuzosin, pethidine, piroxicam, propoxyphene, ranolazine, amiodarone, dronderone, flecainide, propafenone, quinidine, cholchicine, lurasidone, pimozide, clozapine, dihydroergotamine, ergotamine, methylergonvine, sildafinil, triazolam, midazolam, apalutamide, carbamezapine, phenobarbital, phenytoin, rifampin, St. John’s Wort, bupropion, trazodone, voriconazole, isavuconazonium, itraconazole, ketoconazole, rifampin, clarithomycin, erythromycin, amlodipine, diltiazem, felodipine, nicardipine, nifedpine, digoxin, salmetrolsome
  • suggest avoiding concomitant use of Paxlovid and Systemic Corticosteroids
  • No available data in pregnant women or those that are breastfeeding
  • Not authorized in those younger than 12 years of age
  • no cost to patient, $530 cost to US Government

Molnupiravir

Molnupiravir can be found in Epic

Information about Molnupiravir [Lagevrio]

  • nucleoside analog that leads to viral lethal mutagenesis
  • MOVe-OUT Trial (n=1,433), 709 received molnupiravir, 699 patients received placebo.
  • 29 day combined hospitalization or death for molnupiravir group was 6.8% and 9.7% in placebo arm. RRR = 30%, ARR = 2.9%.
  • Number needed to treat to prevent 1 hospitalization or death on molnupiravir = 35
  • 29 day mortality in molnupiravir arm was 0.1% and 1.3% in placebo arm. RRR = 92%, ARR = 1.2%
  • Number needed to treat to prevent 1 death on molnupiravir = 83
  • EUA for molnupiravir can be found here
  • must be 18 years oldstart within 5 days of symptom onsetRx: 800mg BID X 5 days (40 pills)200mg pills, 4 pills each dose (comes in a 40 pill bottle)
  • Do NOT take if pregnant (embryo toxicity); bone/cartilage toxicity (no peds)
  • No known drug interactions
  • no cost to patient, $712 cost to US Government

To find a pharmacy with Molnupiravir, use this website (as of 1/28/22, Port Charlotte is closest location):
HHS/DOH COVID TREATMENT LOCATOR (Monoclonals, Paxlovid, Other)

Fluvoxamine

  • Non-pregnant, adult patients can potentially receive Fluvoxamine as part of ACTIV-6. However, if patient does not want to join research study or definitively wants/needs Fluvoxamine, this is reasonable given clinical data to prescribe.
  • The data for use of Fluvoxamine is found on the USF Emergency Medicine Blog
  • Clinical trial dosing was 100mg PO BID X 10 days (this is moderately large dose and can be associated with nausea; consider giving ondansteron RX with Fluvoxamine RX
  • Possible drug interactions (from the prescribing information which can be found at this link) with BZD, clozapine, methadone, mexiltine, antipsychotics, ramelton, theophyline, warfarin, NOACs, carbamazepine, sumatriptan, TCAs, tacrine, tryptophan, diltiazem, propranolol, metoprolol

Sotrivimab and Remdesvir

  • There is limited effectiveness of Eli-Lilly and Regeneron monoclonal antibody infusions for Omicron based on lab based studies.
  • Sotrovimab does have effectiveness against Omicron but there is very limited availability of the medication and requires high risk/immunocompromised conditions to access.
  • remdesvir is also available as outpatient but also requires high risk features and 3 days of return encounters.
  • Sotrovimab and remdesvir can be given in the GEDI at TGH to very high risk patients.
  • Patients and community providers can complete the referral form themselves.
  • TGH emergency medicine providers/TGH providers can utilize the AMB REFERRAL TO COVID 19 FOLLOW UP.
  • GEDI LINK: The patient and community provider link to GEDI Infusion for Sotrovimab and Remdesvir is here and can be completed by patient or provider
  • Sotrovimab and remdesvir referrals to GEDI from TGH/USF System can be made using the AMB Referral to Covid-19 Follow Up Patients must be high risk for sotrovimab or remdesvir infusion.

Epic Smart Phrase For All Outpatient Treatments and Risk Score for Mabs/Infusions



Other Outpatient Covid Treatment Options(USF Medicine, NIH, Collected Guidelines)

Non-Pregnant Patients

  • Vitamin D 5,000 units daily
  • encourage hydration
  • recommend prone positioning at home every 1 hour every 4 hours

Pregnant Patients

  • Can still be offered Vitamin D
  • Can be offered inhaled budesonide
  • Should not be prescribed fluvoxamine, molnupiravir, or paxlovid and are not eligible for ACTIV-6
  • Should not be advised to prone at home

Head over to the FCEP EM Pulse Winter/Spring 2022 Issue to see our new feature article!

Notes From the Field: Reducing Harm Among Injection Drug Users During and After the Emergency Department Visit

by Heather Henderson, MA, CAS, Asa Oxner, MD, Bernice McCoy, PhD, MPH, Jason Wilson, MD, MA and FACEP | Jan 25, 2022

Notes From the Field: Reducing Harm Among Injection Drug Users During and After the Emergency Department Visit

Website now updated to add the USF EM Social Emergency Medicine Section!

Check this link to learn more about how we are addressing social determinants of health, healthcare disparities, health outcome inequities, and structural competency in the construction of patient centered pathways!

USF EM focuses on the assemblage of new care pathways through direct engagement and involvement of social scientists. We place social scientists (anthropologist) into the clinical space. This work has been best exemplified by our efforts to conduct non-targeted HIV and HCV screening and linkage to care, as well as the construction and implementation of an opioid use disorder bridge program utilizing buprenorphine, and the operation of a prehospital/out of hospital space syringe exchange program that moves us closer to a regional coordinated harm reduction system.

Our USF EM SEM team also have worked to vaccinate refugees, explore vaccine hesitancy in the ED, and investigate healthcare disparities and inequity in female health, including differential rates of endometrial cancer and potential opportunities for ED screening/intervention.

Read more about these efforts at our site!

Our USF EM SEM Section works to meet the goals outlined by the ACEP Social Emergency Medicine Vision Statement and follows the vision outlined by readings and projects conducted through the SAEM Social Emergency Medicine and Population Health Section

Academic Medicine Publication – Patient Shadowing

Jason Wilson, Roberta Baer and Seiichi Villalona are pleased to announce publication of our article in Academic Medicine which highlights the success we have had implementing a premed patient shadowing program that builds in a patient experience perspective into the preclinical years at the University of South Florida. The article is available for free at the Academic Medicine website. 

Patient shadowing early in training allows a shift in the clinical gaze that pays off in the long game in the development of future physicians


The article is available for free at this link

The article is available for free at this link
The PubMed citation is available here and the PMID is 31335819

NEJM Case Studies in Social Medicine Series

  1. Case Studies in Social Medicine — Attending to Structural Forces in Clinical Practice. Stonington Et al., November 2018
  2. The Power and Limits of Classification — A 32-Year-Old Man with Abdominal Pain. Stoumsa et al., May 2019
    1. ARITCLE
    2. PODCAST
  3. The structural violence of Hyperincarceration — A 44 year old man with back pain. Karandinos and Bourgois January 2019
  4. Structural Racism — A 60 yo black woman with breast cancer. Pallok et al., April 2019
  5. Structural Differential – A 32 year old man with persistent wrist pain. Seymour et al. May 2019
  6. Structural Iatrogenesis – A 43 year old man with “opioid misuse”. February 2019
  7. Misrecognition and Critical Consciousness — An 18-Month-Old Boy with Pneumonia and Chronic Malnutrition

Non Medication Approaches to Pain Management – but need focus on acute and sub-acute pain

 

Non-medication approaches to pain management are critical contributions to clinical science. This JAMA interview lays out how 11 trials will be funded based on preliminary data showing possible benefit. While this interview and these trials are important, the focus, like most pain management related research is on chronic pain. Our work (foam rollers, movement, and TENS units) is beginning to focus on pain in the ED – a population most researchers have traditionally shied away from when testing non-medication analgesic approaches.