PCORI Biweekly COVID-19 Scan: Reinstating Mask Mandates, Potential Treatment for COVID-19 and ARDS (July 8-21, 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.
COVID-19 cases caused by the Delta variant are surging among unvaccinated people and younger age groups in the United States. In the face of this, some cities and professional organizations are rethinking the loosening of mask and social distancing mandates (see Topics to Watch).
Prevention of even mild cases of COVID-19 could be important to the future of American health, especially as we learn more about long COVID-19 in adults and, increasingly, in children. A study in the United Kingdom found that at least 1 symptom lasted for 5 weeks after diagnosis in 9.8% of children aged 2 to 11 years and 13% in those aged 12 to 16 years.
The search for promising treatments to be used earlier in the disease course continues (see Topics to Watch for one oral candidate). But caution is warranted against too rapidly accepting research results. In July, two meta-analyses of ivermectin trial results, one in Open Forum Infectious Diseases and one in American Journal of Therapeutics, concluded that ivermectin increased survival for patients with COVID-19, with the latter stating: “The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.” However, a report issued as a preprint without peer review, which was one of the key studies in these meta-analyses, has been withdrawn and is under formal investigation. Allegations against the study range from reporting inconsistencies and simple data errors to plagiarism and data cloning with manipulation.
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.
Reinstating Mask Mandates to Prevent COVID-19 Transmission
At a Glance
- Health care groups such as National Nurses United and pediatricians are urging the federal government to resume its guidance on universal masking to reduce the spread of COVID-19 and protect the public.
- After the lifting of preventive guidelines, such as limited capacity, social distancing, and masking, coronavirus infections and hospitalizations have been steadily increasing.
- First discovered in India in December 2020, the Delta variant is now the predominant COVID-19 variant in the United States, and it is considered more contagious and severe than other known variants.
- Although vaccines remain an effective tool for containing COVID-19, mask mandates for vaccinated and unvaccinated people may be widely implemented to curb the recent surge of cases.
Description
Reinstatement of mask mandates is a public health intervention in response to a recent increase in COVID-19 cases occurring across the country and the appearance of the Delta variant in the United States. These factors have prompted Los Angeles County to reinstate its mask mandate. Many health care groups are asking the federal government to do the same and recommend that Americans wear masks in public, especially indoors and at schools, to reduce the spread of COVID-19.
States have reported increases in cases and hospitalizations in the past few weeks, which coincides with the reopening plans and lifting of public health measures (eg, masking, social distancing, being tested after exposure, and waning vaccination rates). According to the Centers for Disease Control and Prevention, the Delta variant accounted for about 83% of newly confirmed COVID-19 cases as of July 20, 2021. The Delta strain of the SARS-CoV-2 virus was first discovered in India and is more transmissible and known to pose a higher risk of hospitalizations than other variants.
Most cases occur in unvaccinated people, but vaccine breakthrough cases have been observed. According to the World Health Organization, individuals who are vaccinated but infected can still transmit viral particles to others through breathing and speaking. Masking creates a barrier to prevent the viral respiratory droplets from reaching other people, thereby reducing its transmissibility. If reinstated, masking would be mandatory irrespective of vaccination status.
Commentary
Reestablishing mask mandates might improve patient and population health outcomes by helping to mitigate a resurgence in COVID-19 transmission and hospitalizations.
Early feedback from ECRI internal stakeholders suggested that this public health initiative might play a role in controlling the resurgence of COVID-19 cases, because vaccinations do not provide 100% protection against infection and people are generally unaware of others’ vaccination status.
Relaxed public health control measures have led to a recent increase in infections, and the reinstatement of mask mandates might help to reduce the spread of COVID-19, especially in crowded and indoor areas. Mask mandates might have large-scale social and economic impacts because they would allow businesses to continue operations, rather than closing during infection surges. However, stakeholders were concerned that mask mandates might increase distrust in government-issued guidance, because many mandates were lifted in May and June 2021 after recommendations from state officials.
- Category: Public health
- Areas of potential impact: Patient outcomes, population health, health care disparities, health care costs
Tempol to Treat COVID-19 Patients at High Risk of Progressing to Acute Respiratory Distress Syndrome
At a Glance
- Tempol is an investigational oral antiviral, anticoagulant, and antioxidant drug intended to treat adults with early-stage COVID-19 who are at high risk of disease progression to acute respiratory distress syndrome (ARDS).
- The drug is also being investigated to treat respiratory diseases including asthma, respiratory syncytial virus, and influenza.
- Tempol is thought to target COVID-19 disease processes through multiple mechanisms of action, including viral replication, inflammation, coagulation, and oxidative processes. It might provide an oral, outpatient treatment to help mitigate the risk of severe complications in patients with COVID-19 at high risk of progressing to ARDS and reduce coronavirus transmission in the community if infection times are shortened.
- An ongoing phase 2/3, randomized, placebo-controlled clinical trial is investigating the effect of Tempol on hospitalization rates in 310 adults with early COVID-19 who are at high risk of developing ARDS, with an estimated primary completion date of December 2021.
- The manufacturer announced plans to file for an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA), pending positive results from the phase 2/3 trial.
Description
Tempol (APC-400, MBM-02; Adamis Pharmaceuticals Corp, San Diego, California) is an investigational oral drug with antiviral, anticoagulant, and antioxidant properties being developed to treat respiratory diseases including asthma, respiratory syncytial virus, influenza, and COVID-19 infections, including adults with early-stage COVID-19 who are at high risk of disease progression to ARDS. Comorbidities that put patients at high risk for ARDS include cancer, chronic kidney disease, diabetes mellitus, hypertension, immunodeficiency, and obesity. Tempol might provide an oral, outpatient treatment to help reduce the risk of severe complications in these patients.
Tempol is thought to target COVID-19 disease processes through multiple mechanisms. Tempol purportedly disrupts the formation of iron-sulfur clusters thought to be essential in the replication of the virus’s genetic material. Tempol also purportedly mitigates hyperinflammation by preventing immune cells from releasing proinflammatory cytokines. Viral replication and elevated inflammatory cytokines (ie, cytokine storm) put patients at risk of ARDS, multiple-organ failure, and death. Researchers also think that Tempol might have anticoagulant and antioxidant properties that could help prevent blood clots and reduce damage to the organs that is associated with oxidative stress.
An ongoing phase 2/3, randomized, placebo-controlled clinical trial is investigating the effect of twice-daily Tempol on reducing hospitalization rates in 310 adults with early COVID-19 who are at high risk of ARDS. Its estimated primary completion is in December 2021. The manufacturer announced plans to file for EUA from the FDA, pending positive results from the phase 2/3 trial. We were unable to find information regarding the potential cost of a treatment course of Tempol.
Commentary
Tempol is an investigational therapy taken by mouth to treat early COVID-19 in patients with increased risk of disease progressing to ARDS. It could become the first oral antiviral treatment for use in the outpatient setting, which might help prevent hospitalizations for COVID-19 and reduce coronavirus transmission in the community if infection times are shortened.
Initial comments from ECRI internal stakeholders suggested that Tempol, if effective, might improve patient health outcomes and reduce health disparities in patients at high risk of COVID-19 disease progression. It could become a standard-of-care treatment for use in the outpatient setting as the first oral antiviral treatment for COVID-19.
Early and effective treatment of COVID-19 might reduce hospitalizations and associated health care costs, thus lessening the burden on the health care system. Additionally, population health outcomes might improve, if initiating Tempol early in the COVID-19 disease were to show reduced viral load and duration of illness in patients, reducing transmission in the community.
- Category: Public health
- Areas of potential impact: Patient outcomes, health care disparities, 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: July 30, 2021
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