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.
Attention is turning to those who are not vaccinated. Many people—from the current US administration to academic teams—are exploring why some people are still unvaccinated and how to overcome the gap.
A recent investigation found that only 20 US state vaccination distribution plans referenced a health equity committee and only 8 had minority representatives on the planning committee. Data gathered by the academic group CommuniVax led its investigators to warn against the tendency to blame vaccine hesitancy. Limited transportation, inability to take time off work, lack of child care, and the possibility of lost work or need for uninsured care because of side effects are some of the factors keeping those in underserved communities away from vaccination sites. See Topics to Watch for an initiative aimed at increasing vaccination rates among people who speak Spanish.
A gender gap is also developing. As of July 6, almost 9.5 million more women than men had been vaccinated in the United States, according to the Centers for Disease Control and Prevention. The dominance of women in groups with the earliest access, existing gender differences in attitudes toward health care in general, and political ideology are possible reasons for the gap. Men are known to have a higher risk of death from COVID-19, yet only 4% of 4420 COVID-19 clinical trials (registered from January 1, 2020, to January 26, 2021) used the sex of participants as an analytical variable.
Health care workers are still fighting COVID-19 every day (see Topics to Watch for a potential new treatment). That’s unlikely to change if these disparity gaps keep vaccination rates stagnant at the same time as the more transmissible Delta variant gains dominance in the United States.
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.
Aviptadil (Zyesami) to Treat Critical COVID-19 With Respiratory Failure
At a Glance
- Aviptadil is an investigational, intravenous, and synthetic form of human vasoactive intestinal polypeptide (VIP) used to treat patients who have critical COVID-19 with respiratory failure.
- Aviptadil is thought to prevent viral replication, reduce inflammation, and increase surfactant production, to treat and prevent damage to the lung cells that absorb oxygen into the body.
- In June 2021, the company reported data from a phase 2/3, randomized, placebo-controlled trial of 196 patients with critical COVID-19 and respiratory failure. It found that at 60 days, patients treated with aviptadil had a median 10-day shorter length of hospitalization and were more likely to be alive and free from respiratory failure.
- Also in June 2021, the company submitted a request to US Food and Drug Administration (FDA) for emergency use authorization (EUA) for aviptadil to treat patients who have critical COVID-19 and respiratory failure that have not responded to other treatments.
Description
Treatment options for critical COVID-19 patients with respiratory failure are limited. Aviptadil (Zyesami; formerly RLF-100) is an investigational synthetic form of VIP administered intravenously to treat patients who have COVID-19 with respiratory failure.
VIP is responsible for regulating multiple functions in alveolar type 2 cells in the lung, including the production of the lung surfactant that protects lung cells and helps them absorb oxygen into the body. SARS-CoV-2 binding and cellular entry damages these cells and causes inflammation, which results in decreased surfactant production, oxygen insufficiency, and lung injury. Aviptadil is thought to reduce viral replication and inflammation, as well as lung cell damage, by increasing surfactant production. This mitigates lung injury and risk of death.
A phase 2/3 clinical trial of 196 adults in intensive care with COVID-19 found that patients treated with aviptadil and standard care had a median 10-day reduction in length of hospital stay and were more likely to be alive and free from respiratory failure at 60 days, compared with those outcomes under standard care alone. An ongoing phase 3 trial evaluating aviptadil with standard care has primary completion expected in October 2022. The drug became available through an FDA Expanded Access Protocol (EAP) in July 2020 to patients aged 12 years or older.
In June 2021, the developers submitted a revised request for an EUA to the FDA for aviptadil for patients with critical COVID-19 and respiratory failure whose disease has exhausted all approved treatments, based on the 60-day follow-up data from the phase 2/3 trial. The FDA denied the developer’s first request for EUA in December 2020, which was based on data from the open label study. ECRI authors were unable to find information regarding the potential cost of a treatment course of aviptadil.
Commentary
Aviptadil is an investigational intravenous therapy for treating patients with critical COVID-19 and respiratory failure. Its novel mechanism of action might help mitigate or reverse multiple processes involved in severe lung injury, including viral replication, inflammation, and lung surfactant production. Treatments for these critically ill patients are limited.
Early feedback from ECRI internal stakeholders suggested that, if effective, aviptadil might provide a novel treatment for preventing and treating respiratory failure and improve patient health outcomes and survival. Early data suggested that aviptadil might also decrease demands on the health care system by decreasing the length of hospitalization. NeuroRx Inc (Wilmington, Delaware) and Relief Therapeutics (Geneva, Switzerland) have contracted with Nephron Pharmaceuticals (Radnor, Pennsylvania) and Bachem Americas (Pfaeffikon, Switzerland) to manufacture up to 1 million doses of aviptadil, pending receipt of the EUA, which might make the treatment widely available.
- Category: Treatment
- Areas of potential impact: Patient outcomes, patient management, health care costs
WhatsApp Chat in Spanish Seeks to Improve Vaccine Equity
At a Glance
- The WhatsApp chat initiative is intended to improve information access and vaccination rates among US Hispanic people to reduce COVID-19 infection spread, death rates, and health care costs related to COVID-19 in this target population.
- This chat is called “Mi Chat Sobre Vacunas COVID” or “My Chat about COVID Vaccines" and can be accessed by scanning a QR code or clicking on a specific link.
- It has information in Spanish about nearby vaccination sites, transportation to the vaccination sites, and answers to frequently asked questions.
- According to a 2021 survey, 46% of Hispanic Americans use WhatsApp, more than Americans identifying as Black (23%) or White (16%), making this app suitable for a vaccine promotion initiative.
- As of July 4, 2021, data from the US Centers for Disease Control and Prevention (CDC) showed that 34% of people who initiated COVID-19 vaccination in the past 14 days identified themselves as Hispanic, while Hispanic people make up 17% of the US population, suggesting an encouraging recent increase in vaccine uptake in the population.
Description
According to the Kaiser Family Foundation’s analysis of CDC data, as of July 4, 2021, 16% of Hispanic people had received at least one dose of COVID-19 vaccine, compared with 59% of Whites in the total population of vaccinated US individuals for whom race/ethnicity is known (58% of all vaccinated individuals). The WhatsApp chat initiative is intended to increase vaccination rates among the US Hispanic population to improve information access and reduce COVID-19 infection spread, death rates, and health care costs related to COVID-19 in this target population. On June 14, 2021, the CDC launched a WhatsApp chat as part of the National Month of Action initiative to mobilize as many people as possible to get at least one dose by July 4, 2021. This chat is called “Mi Chat Sobre Vacunas COVID” or “My Chat about COVID Vaccines" and can be accessed by scanning a QR code or clicking on a specific link.
The user must reply with “hola,” (hello) to access a menu of options that includes information about nearby vaccination sites, transportation, and answers to frequently asked questions. This WhatsApp chat is intended to increase uptake of COVID-19 vaccines by providing reliable information in Spanish about the COVID-19 vaccines.
A 2021 survey of 1502 nationally representative US adults on social media use showed that 46% of Hispanic Americans use WhatsApp, more than Americans identifying as Black (23%) or White (16%), making this app suitable for a vaccine promotion initiative. As of July 4, 2021, data from the CDC showed that among all vaccinated U.S. people with known race/ethnicity (58% of all vaccinated individuals) who initiated COVID-19 vaccination in the past 14 days, 34% were Hispanic, while Hispanic people make up 17% of the US population, suggesting an encouraging recent increase in vaccine uptake in the population.
Commentary
The WhatsApp chat initiative in Spanish might improve population health outcomes and reduce barriers faced by Spanish-speaking communities with low English proficiency. It might increase vaccine uptake by educating users about the COVID-19 vaccines and provide accessible information about vaccination sites. It might also reduce both the death rate and health care costs related to COVID-19 cases occurring in this population.
Early feedback from ECRI internal stakeholders suggests that the WhatsApp chat initiative in Spanish might promote vaccinations among US Hispanic people. However, some users might still find it hard to overcome distrust of the health care system. The chat might not relieve disparities for those who are not technologically savvy or do not own a mobile phone. App users might also have concerns about how their information (eg, location, phone number) could be misused. It might, however, reduce vaccine hesitancy and help counter misinformation regarding COVID-19 vaccines in this population.
- Category: Public health
- Areas of potential impact: Patient outcomes, population health, health care disparities, health care costs
We welcome your comments on this Scan. Send them by email to [email protected] or
by mail to: Patient-Centered Outcomes Research Institute, 1828 L Street, NW, Suite 900, Washington, DC 20036.
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. |
Posted: July 15, 2021