PCORI Biweekly COVID-19 Scan: Drive-through Vaccination Clinics, Nitazoxanide (March 4-17, 2021)
Briefing
The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.
Every good look forward starts with a good look back. And people are looking forward, just as horizon scanning does, as the nation reflects on the 1-year anniversary of the pandemic.
Looking back at the responses of governments around the world might clarify which public health policies worked best and help create lists of threats—lists once familiar only to infectious disease experts and horizon scanners—that could become part of strategic planning going forward. A nimbler approach to the development of “broadly active family-specific and cross-family therapeutics” might enable us to not just control but treat the next threat.
The emerging aspects of long COVID are highlighting a gap in the US health system’s ability to address and understand post-viral syndromes as a whole. Patients and advocates are raising concerns about an impending health crisis and calling for new ways to both measure and treat lingering signs and symptoms. Data from electronic health records might create a predictive model for who might develop long COVID. CytoDyn, Inc (Vancouver, Washington) has announced a phase 2 trial of leronlimab-PRO 140 (Vyrologix) to treat long COVID.
Innovation continues as vaccines roll out (see Topics to Watch) and as signs of effectiveness roll in, even among the most vulnerable. However, as the rates of serious hospitalization and death fall, a pressing need remains for effective treatment of those with mild to moderate COVID-19 (see Topics to Watch).
ECRI Horizon Scanning has selected the topics below as those with potential for impact relative to COVID-19 in the United States within the next 12 months. All views presented are preliminary and based on readily available information at the time of writing.
Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.
Drive-through COVID-19 Vaccination Clinics
At a Glance
- Drive-through vaccination sites could accelerate the effort to vaccinate all eligible or interested persons, now that three COVID-19 vaccines are being distributed across the country after receiving Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
- This model was used in Louisville, Kentucky, during the 2009 swine flu outbreak to deliver about 19 000 vaccine doses in 1.5 days.
- The Centers for Disease Control and Prevention (CDC) has published considerations for planning drive-through clinics for routine vaccinations, which might also be useful for distributing COVID-19 vaccines.
- Several states are building drive-through vaccine clinics, including a site in Montgomery County, Pennsylvania, with a 10-lane carport, as well as in Texas, which has established multiple mass drive-through clinics.
Description
Three COVID-19 vaccines have received EUA from the FDA and are being distributed across the country. Drive-through vaccination sites could accelerate the effort to meet the nation’s long-term goal of vaccinating all people seeking vaccination. During the swine flu (or H1N1) outbreak in 2009, this model was used in Louisville, Kentucky, to deliver about 19 000 vaccine doses in 1.5 days. The CDC has published considerations for planning drive-through clinics for routine vaccinations, which may also be useful for administering COVID-19 vaccines.
Several states are building drive-through clinics. For example, a site in Montgomery County, Pennsylvania, has a 10-lane carport and has retrofitted shipping containers for vaccine and medical-equipment storage. Other sites across the country have already begun administering COVID-19 vaccines to individuals, based on their risk allocation, in mass drive-through clinics. For example, Texas has been adding mass vaccination sites as more doses arrive in the state.
Commentary
Drive-through vaccination clinics might improve throughput and streamline vaccine administration while promoting social distancing to reduce the risk of transmitting COVID-19.
Early feedback from ECRI internal stakeholders suggested that these initiatives could speed up vaccination rates. However, bottlenecks might occur because of limited vaccine supply and inadequate staffing. Bottlenecks might also occur because people should be observed for either 15 or 30 minutes after vaccination, depending on their history of allergic reactions. Traffic congestion and air pollution from cars idling might also occur. Mass drive-through vaccination sites might be impractical for routine vaccinations after the pandemic.
On the other hand, the intervention might reduce disparities by improving vaccine access for people with disabilities or others with barriers to entering indoor vaccination sites. These sites could be more feasible to run even in poor weather and might help reduce appointment cancellations or no-shows, limiting wasted vaccine doses. Stakeholders thought that drive-through clinics would supplement current vaccination centers rather than replace them and could be useful for disseminating variant boosters, if needed.
- Categories: Systems and management
- Areas of potential impact: Patient outcomes, population health, health care delivery and process, health care disparities, health care costs
Nitazoxanide (NT-300) to Treat Mild to Moderate COVID-19
At a Glance
- Nitazoxanide, an FDA-approved oral broad-spectrum antiparasitic drug, is being developed as the extended-release form NT-300 to treat mild to moderate COVID-19.
- Laboratory cell cultures have shown that nitazoxanide exhibits broad-spectrum activity against multiple respiratory viruses, and the drug purportedly suppresses the production of proinflammatory cytokines thought to contribute to severe COVID-19 and poor outcomes.
- A phase 3, randomized, placebo-controlled trial of 1092 participants with mild or moderate COVID-19 had an estimated study completion in February 2021.
- Based on available clinical trial dosing and pricing information for 500-mg tablets, we estimate a 5-day course of nitazoxanide to treat COVID-19 to cost less than $1300.
Description
Nitazoxanide is an oral antiparasitic drug that the FDA has approved to treat diarrhea caused by Cryptosporidium parvum and Giardia lamblia (“traveler's diarrhea”). An extended-release form called NT-300 is being developed by Romark Laboratories, LC (Tampa, Florida), to treat mild to moderate COVID-19 in the outpatient setting.
In laboratory cell culture, the manufacturer claims nitazoxanide exhibits broad-spectrum antiviral activity including against respiratory viruses such as SARS-CoV-2, SARS-CoV (severe acute respiratory syndrome–associated coronavirus), MERS-CoV (Middle East respiratory syndrome coronavirus), and influenza, as well as other viruses that cause the common cold. Additionally, nitazoxanide purportedly suppresses the production of proinflammatory cytokines thought to play a role in COVID-19–associated hyperinflammation, severe disease, and poor outcomes.
No clinical data have been reported. NT-300 is being investigated in a developer-sponsored, phase 3, randomized, placebo-controlled, clinical trial of 1092 participants with mild or moderate COVID-19. The trial’s estimated study completion was in February 2021, but the trial’s record, updated February 8, 2021, lists the trial as still active. In clinical trials, NT-300 is taken by mouth twice daily for 5 days. Based on available clinical trial dosing and pricing information for 500-mg tablets (300-mg tablets are taken in trials but are commercially unavailable), we estimate a course of nitazoxanide to treat COVID-19 to cost less than $1300.
Commentary
Nitazoxanide is a repurposed, oral drug in development as an extended-release formulation for treating mild to moderate COVID-19.
Early feedback from ECRI internal stakeholders suggested that preclinical data demonstrating nitazoxanide's antiviral and anti-inflammatory mechanisms of action are promising. If effective clinically, the drug might improve patient outcomes and keep patients out of the hospital by treating COVID-19 symptoms early and preventing disease progression.
The drug presents an important new treatment option because it can be taken by mouth in the outpatient setting and might be less expensive and more convenient than intravenously administered monoclonal antibody therapy. It might reduce health disparities among groups that face disproportionate progression to severe disease. Stakeholders also thought nitazoxanide might help decrease the burden on the health care system, use of intensive resources, and hospitalization-related health care costs.
- Category: Treatments
- Areas of potential impact: Patient outcomes, population health, health care costs
Horizon scanning is a systematic process that serves as an early warning system to inform decision makers about possible future opportunities and threats. Health care horizon scanning identifies technologies, innovations, and trends with potential to cause future shifts or disruptions—positive or negative—in areas such as access to care, care delivery processes, care setting, costs of care, current treatment models or paradigms, health disparities, health care infrastructure, public health, and patient health outcomes.
The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning to better inform its patient-centered outcomes research investments. Initially, PCORI defined the HCHSS project scope to focus on interventions with high potential for disruption in the United States in 5 priority areas: Alzheimer’s disease and other dementias, cancer, cardiovascular diseases, mental and behavioral health conditions, and rare diseases. In addition, the system captures high-level disruptive trends across all clinical areas, which may lead PCORI to expand the project scope to include other priority areas in the future.
In early 2020, the COVID-19 pandemic created a fast-moving, widespread public health crisis. In May 2020, PCORI expanded its HCHSS to elucidate the landscape of potentially impactful applications for COVID-19. The HCHSS COVID-19 supplement scans for, identifies, monitors, and reports on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact to patient outcomes—for individuals and populations—in the United States in the next 12 months.
The HCHSS COVID-19 supplement produces 3 main outputs:
- Biweekly COVID-19 Scans (eg, this document) provide ECRI Horizon Scanning with a vehicle to inform PCORI and the public in a timely manner of important topics of interest identified during ongoing scanning and topic identification or through the ECRI stakeholder survey process.
- Status Reports (quarterly) briefly list and describe all COVID-19-related topics identified, monitored, and recently archived.
- High Impact Reports (every 4 months) highlight those topics that ECRI internal stakeholders (eg, physicians, nurses, allied health professionals, public health professionals, first responders, health systems experts, clinical engineers, researchers, business and finance professionals, and information technology professionals) have identified as having potential for high impact relative to COVID-19 in the United States.
Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.
We welcome your comments on this Scan. Send them by email to [email protected].
Posted: March 25, 2021
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