PCORI Biweekly COVID-19 Scan: Diagnosing Post-COVID Conditions, Treatment for Severe COVID-19 (September 1-14, 2022)
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.
Although there are signs that the worst of the COVID-19 pandemic is over, hundreds of people die from COVID-19 or from COVID-19–related complications each day in the US, making COVID-19 the third-leading cause of death, after heart disease and cancer, for the third year in a row. New treatments are needed (see Topics to Watch for a new small-molecule drug), not just for COVID-19 but also in preparation for future emerging infectious diseases. The Cumming Global Centre for Pandemic Therapeutics (CGCPT) in Australia hopes to go beyond the small-molecule model to find a new platform to repurpose drugs as threats arise.
Some hospitals are also preparing for future pandemics with large-scale remodeling projects based on lessons learned about surge capacity, flexible use of space, and ventilation needs during the COVID-19 pandemic. Outpatient centers, however, have not initiated the same level of response and the risk of SARS-CoV-2 infection during routine doctor’s office visits largely remains. Outbreaks have been traced to outpatient clinics and a sample suggests that many are unlikely to meet minimum Centers for Disease Control and Prevention (CDC) recommendations for air changes per hour.
A global private venture is looking at treatments to help in the aftermath of infectious disease. The Long Covid Research Initiative (LCRI) launched a program to cover tissue biopsy studies, autopsy and imaging studies, blood-based biomarker studies (see Topics to Watch for a new diagnostic), studies of the consequences of SARS-CoV-2 persistence, and studies on pathogenic reactivation and impacts on the human microbiome.
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.
IncellKINE Long COVID In Vitro Diagnostic to Diagnose Post-COVID Conditions
At a Glance
- IncellKINE is a blood test intended to diagnose post-COVID conditions (PCC) and differentiate it from acute COVID-19 based on patterns of inflammatory markers.
- It quantifies 14 cytokines and chemokines, proteins that are key modulators of the body’s immune response, which are then examined for patterns with a machine learning algorithm.
- A published study of IncellKINE found it was 97% accurate in identifying patients with PCC and 88% accurate in correctly identifying patients with severe COVID-19.
- Although no diagnostic tests are authorized in the United States for PCC, individuals can access IncellKINE online for off-label use. IncellKINE received marketing approval in the European Union in September 2022.
Description
IncellKINE Long COVID In Vitro Diagnostic, developed by IncellDx (San Carlos, California), is a blood test intended to diagnose post-COVID conditions (PCC) and differentiate it from acute COVID-19.
As many as 20 percent of COVID-19 patients are estimated to experience PCC, also known as long COVID, which encompasses a broad range of new or worsening symptoms lasting months after the acute infection has resolved. COVID-19 severity and PCC are associated with dysregulated immune responses. Thus, the manufacturer developed IncellKINE on a machine learning model of immune-based prediction of COVID-19 severity and chronicity and the assumption that PCC might develop as a result of impaired antiviral response against SARS-CoV-2 RNA or protein.
IncellKINE quantifies 14 cytokines/chemokines, which are then examined for patterns with a machine learning algorithm. In a study of 224 participants (26 patients with mild-to-moderate and 48 with severe COVID-19, 121 patients with PCC, and 29 healthy controls), IncellKINE was 97 percent accurate in correctly identifying patients with PCC and 88 percent accurate in correctly identifying patients with severe COVID-19.
No diagnostic tests for PCC are currently authorized in the US. At the time of this writing, IncellKINE is offered as part of a consultation service that uses off-label experimental treatments through the Chronic COVID Treatment Center. The IncellKINE kit has been validated by Clinical Laboratory Improvement Amendments (CLIA) laboratories, and is offered as a laboratory developed test (LDT) to better identify and characterize immunological abnormalities in PCC patients, for guiding treatment. Patients get their blood drawn at a local laboratory, receive results via a secure online portal, they can consult with an IncellDx clinician through telehealth, and receive a treatment plan to discuss with their primary care physician. IncellKINE received marketing approval in the European Union in September 2022.
We were unable to find cost information for the IncellKINE test. The Chronic COVID Treatment Center states it provides relevant current procedural terminology (CPT) codes and patients may submit to health insurers for reimbursement consideration.
Commentary
IncellKINE might help meet the unmet need for reliable diagnostic testing to identify patients with PCC.
Early feedback from ECRI internal stakeholders suggested that IncellKINE might increase access to diagnostic testing for PCC, which might support the development of effective PCC treatments and inform their use as other treatments become available. Obtaining a definitive diagnosis might lessen the impact of an uncertain PCC diagnosis and improve the quality of life for those individuals. Additionally, stakeholders noted that the IncellKINE test could easily be adapted and enhanced when new evidence becomes available regarding specific PCC biomarker profiles.
However, stakeholders expressed concern about the broad variability in insurance coverage for testing and subsequent treatment of PCC for those diagnosed, which could potentially worsen health disparities for low-income individuals. Additionally, there are currently no approved treatments for PCC, which might leave the management of PCC after diagnosis unclear.
- Category: Screening and diagnostics
- Areas of potential impact: Patient outcomes, population health, health care delivery and process, health care disparities, health care costs
Sarconeos (BIO101) to Treat Severe COVID-19
At a Glance
- Sarconeos (BIO101) is a small-molecule drug being developed to prevent further respiratory deterioration in hospitalized adults with severe COVID-19 at risk of respiratory failure or death.
- Sarconeos intends to activate the Mas receptor, part of the protective arm of the renin-angiotensin system (RAS), to rebalance the RAS and improve respiratory function.
- Recently reported phase 2/3 clinical data showed Sarconeos produced a 39% lower relative risk of respiratory failure or early death at day 28 compared with placebo, although this finding did not achieve statistical significance. Sarconeos did significantly delay progression of respiratory failure or early death at day 28 compared with placebo.
- Sarconeos’ developer Biophytis might amend and continue an Early Access Program to make Sarconeos available as early as this winter, which might help enable a later regulatory submission to the FDA.
Description
Sarconeos (BIO101), being developed by Biophytis, SA (Paris, France), is a small-molecule oral drug under investigation to treat adults hospitalized with severe COVID-19 who have respiratory manifestations of the disease (eg, low blood oxygenation, pneumonia) and are at risk of respiratory failure and/or death.
Severe COVID-19 is characterized by excessive inflammation that often leads to respiratory difficulty and lung damage, including scarring (ie, fibrosis). Standard-of-care corticosteroids reduce inflammation but carry risks for serious side effects. Sarconeos is designed to rebalance the RAS, a hormone system with effects on inflammation and fibrosis, to improve respiratory function in patients with severe COVID-19. The RAS is thought to become imbalanced in COVID-19 due to SARS-CoV-2 binding to angiotensin-converting enzyme 2 (ACE2) receptors within the RAS. By activating Mas receptors, Sarconeos is thought to activate the protective RAS arm, helping to counter inflammation and fibrosis and exerting cardioprotective effects.
On September 7, 2022, Biophytis reported top-line results from its phase 2/3 COVA study; Sarconeos reduced the relative risk of respiratory failure or early death at 28 days (the primary end point) by 39 percent compared with placebo (15.8 percent vs 26.0 percent, respectively), although this finding was not statistically significant. Sarconeos did significantly delay progression of respiratory failure or early death over 28 days compared with placebo. In the same news release, Biophytis stated it might amend and continue its Early Access Program to make Sarconeos available as soon as this winter for this patient population, in a first step toward regulatory submission to the FDA.
We were unable to find information regarding the potential cost of Sarconeos.
Commentary
Despite widespread availability of COVID-19 vaccines, SARS-CoV-2 continues to mutate and spread, putting vulnerable individuals such as the elderly and those with preexisting conditions at higher risk of developing more severe COVID-19. Thus, new treatments with potential to improve patient outcomes are needed.
Early feedback from ECRI internal stakeholders suggested additional data are needed to determine the therapeutic potential of Sarconeos. However, stakeholders noted that new treatment options that produce even modest protective effects in the lungs could be important tools against severe COVID-19.
Stakeholders thought Sarconeos, if effective, might lower inflammation without causing systemic immune suppression, unlike corticosteroids, and help protect patients from secondary infections. It could lead to favorable effects downstream of improving respiratory function, such as reducing risk of oxygen deprivation in heart muscle.
- Category: Treatment
- 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.
In May 2021, the COVID-19 supplement was modified and merged with the HCHSS. The Biweekly COVID-19 Scans continue, while the Status Reports and High Impact Reports were folded into the PCORI Horizon Scanning Database and High Potential Disruption Reports.
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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: September 29, 2022
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