COVID-19 manifests differently in different patients. After 6 months of studying the disease, the reasons for these differences are still not fully understood. However, some evidence suggests that the most severe forms of the disease might be related to genetic risk factors, preexisting conditions, and social factors.

A treatment’s impact on COVID-19 patient outcomes is directly related to the nature of the virus and the progression of the disease it causes. Antivirals (eg, remdesivir) and immunosuppressive therapies (eg, dexamethasone; see Topics to Watch) have shown promise in clinical trials. However, a review in Nature considers changes clinicians are seeing in patients’ immune responses over time, suggesting that COVID-19 treatment might need to vary over the course of the disease. For example, a patient might begin on corticosteroids to dampen hyperinflammation and, after a week or so, transition to immune-boosting agents (eg, anti-PD1s). Currently, there are no US-based trials for anti-PD1 treatments.

Description

The Accula SARS-CoV-2 test is a polymerase chain reaction (PCR) assay developed by Mesa Biotech, Inc (San Diego, California) as a point-of-care COVID-19 test. The test is intended to be used at temporary screening facilities, ambulatory care facilities, and long-term care facilities.

The Accula system consists of a single-use cassette that contains chemicals needed to detect certain viral components (ie, nucleic acids). Using nasal and throat swabs, the sample is added into the cassette then placed in the Accula Dock. The dock is a palm-sized device that controls chemical reaction temperatures, timing, and fluid movement within the cassette. When the chemical reaction is complete, the result—indicating whether the viral components have been detected—is displayed on the device.

The manufacturer claims that the Accula system yields laboratory-quality results in about 30 minutes. It is intended to complement central laboratories where most current testing is performed. In March 2020, FDA granted the Accula SARS-CoV-2 test Emergency Use Authorization (EUA). A published study evaluated the performance of the Accula SARS-CoV-2 test in 100 nasopharyngeal samples previously tested by the SARS-CoV-2 PCR Assay, an EUA test developed by Stanford Health Care Clinical Virology Laboratory (Palo Alto, California). The Accula SARS-CoV-2 test had sensitivity of 68% and specificity of 100%.

Commentary

The use of Accula SARS-CoV-2 as a point-of-care test might allow health centers to diagnose COVID-19 soon after a symptomatic patient arrives at a health center. With test results being available in about 30 minutes, this could significantly improve triage times for infected and uninfected patients. Early responses from ECRI internal stakeholders indicated that Accula SARS-CoV-2 might address an unmet need for testing in settings other than central laboratories. However, stakeholders raised concerns regarding the test’s accuracy (ie, 68% sensitivity), which can lead to false-negative test results and decrease its usefulness for screening asymptomatic people before they return to work or school.

• Area of Potential Impact: Patient outcomes, population health, health care delivery and process, health care costs
• Category: Screening and diagnostics

Description

CoviTact is a protease (ie, an enzyme that breaks down proteins) assay developed by ViroTact BV (Groningen, the Netherlands), a subsidiary of Detact Diagnostics BV (Groningen, the Netherlands). It is intended for point-of-care COVID-19 testing at temporary screening facilities, ambulatory care facilities, and long-term care facilities. CoviTact consists of a short peptide (ie, linked amino acids) bound to a near-infrared light (NIRL)-emitting molecule and a quencher molecule that absorbs NIRL. The peptide contains a specific amino acid sequence that is recognized and cleaved only by the SARS-CoV-2 main protease.

Once the protease cleaves the peptide and the NIRL-emitting molecule is no longer close to the quencher molecule, the NIRL can be detected using a device designed to measure various wavelengths of light called a fluorometer. The manufacturer claims that CoviTact can detect SARS-CoV-2 in saliva samples, nasal swabs, and possibly other infectious body fluids, and can confirm COVID-19 cases within minutes in a highly specific way.

Commentary

CoviTact might enable health care providers to detect very low levels of the SARS-CoV-2 virus in test samples. Compared with nucleic acid–based tests (see the Accula SARS-CoV-2 test above), CoviTact might identify infected individuals quicker and at a lower cost. If health centers adopt CoviTact as a point-of-care test, it might decrease triage times for infected and uninfected patients.

Early responses from ECRI internal stakeholders indicated that point-of-care tests such as CoviTact, are critical to help reduce the spread of COVID-19. Implementing CoviTact for clinical use might impact population health by enabling increased testing, contact tracing, and isolation of positive cases. However, stakeholders warned that without accuracy data (ie, sensitivity and specificity) it is challenging to assess CoviTact’s reliability for diagnosing COVID-19.

• Area of Potential Impact: Patient outcomes, population health, health care delivery and process, health care costs
• Category: Screening and diagnostics

Description

Dexamethasone is an immunomodulatory corticosteroid being investigated as an intravenous or oral treatment for severe COVID-19. Hyperinflammation is thought to underlie acute respiratory distress syndrome (ARDS) in COVID-19 and the need for mechanical ventilation. Therefore, use of corticosteroids to reduce inflammation in patients with severe COVID-19 might be beneficial; however, concerns exist regarding the risks of immunosuppression.

Data reported from a randomized, phase 3 clinical trial in the UK in 6425 hospitalized patients with COVID-19 showed that, compared with patients receiving standard of care (n = 4321), patients receiving dexamethasone (n = 2104) had a one-third decrease in deaths in the subset of participants who were ventilated, a one-fifth decrease in deaths in the subset receiving oxygen only, and no benefit in the subset not requiring respiratory support.

An ongoing phase 2 trial in the US is investigating dexamethasone versus placebo to treat moderate to severe ARDS. Data from this trial are expected in September 2020. Based on available clinical trial dosing and pricing information, a course of dexamethasone to treat severe COVID-19 could cost between about $9 and $21.

Commentary

Preliminary data from the UK reported that dexamethasone is the first treatment for COVID-19 shown to reduce deaths. The greatest decrease in deaths was observed in patients requiring mechanical ventilation, suggesting that appropriately treating the hyperinflammation associated with severe COVID-19 might be key to survival. Dexamethasone is an inexpensive, widely available, generic drug that might be beneficial for treating severely ill patients.

Early feedback from ECRI internal stakeholders suggested that dexamethasone might have a significant positive impact within the next year on patient health outcomes and population health and decreasing health care costs. More data are needed to support dexamethasone's efficacy in reducing death rates in patients with severe COVID-19 and to determine which patients might benefit most from receiving the drug. In addition, because of the lack of data, the role of dexamethasone in patients with mild to moderate COVID-19 remains unclear.

• Area of Potential Impact: Patient outcomes, population health, health care costs
• Category: Treatments

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.