PCORI Biweekly COVID-19 Scan: Convalescent Plasma, Remdesivir (August 20-September 2, 2020)
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.
Testing for COVID-19 continues to be key, and the need for test results highlights the dichotomy between slow, expensive, precise molecular tests and fast, less expensive, less precise antibody tests. On August 26, 2020, Abbott announced that its BinaxNOW COVID-19 Ag Card antigen test had received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). The manufacturer claims that the test can diagnose COVID-19 in 15 minutes for $5; however, the FDA conceded that the test is likely to be less sensitive than slower, more expensive molecular tests, meaning the Abbott test is less likely to correctly identify positive cases. Bottom line: More of these tests need to be run to determine how sensitive they actually are.
In this Scan, we report on two EUA treatments (see Topics to Watch). In the context of these treatments, researchers are calling for better evidence for remdesivir and convalescent plasma, patient groups are calling for action, and clinicians are hopeful for proven and widely available options while recognizing that they must make judgments in real time.
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.
Convalescent Plasma to Treat COVID-19
At a Glance
- Convalescent plasma (CP) is a biologic blood product–derived therapy obtained from patients who have recovered from coronavirus infection.
- CP reduced mortality in hospitalized patients with severe acute COVID-19 when given CP earlier or CP samples containing higher levels of coronavirus antibodies.
- On August 23, 2020, the FDA granted an EUA for convalescent plasma products, stating that the benefits of the treatment outweigh the known and potential risks.
Convalescent plasma (CP) is a biologic therapy obtained from patients who have recovered from coronavirus infection. Plasma, the cell-free liquid part of blood, contains high levels of proteins that can mediate antiviral and immunomodulatory effects. CP donated by a single patient might provide enough plasma to treat up to four patients. The FDA has opened an expanded access program to provide CP treatment for patients who have COVID-19.
Hospitalized patients (n = 35 322) with severe acute COVID-19 respiratory syndrome given convalescent plasma sooner (within 3 days of diagnosis vs. 4 or more days) were less likely to die at 7 and 30 days after treatment (p < .001 and p < .0001, respectively). Also, patients given CP with higher neutralizing antibody levels were less likely to die at 7 days after treatment than patients given medium or low levels of coronavirus antibodies (p = .048), according to a preprint publication of a multicenter, open-label, uncontrolled, observational study across the United States and territories. However, a small randomized controlled trial in patients with severe or life-threatening COVID-19 in Wuhan, China (n = 103) found CP with standard treatment did not significantly improve time to clinical improvement within 28 days compared with standard treatment alone.
About 50 ongoing randomized controlled studies of CP are being fed into a living systematic review. On August 23, 2020, the FDA granted an EUA for convalescent plasma products, stating that the benefits of the treatment outweigh the known and potential risks.
Early results with CP are encouraging, but concerns exist regarding the appropriate use of CP, including the risk-benefit ratio (eg, blood-borne disease risk) from widespread administration of plasma products if other, better-controlled options are available. Also, extensive use of plasma products for coronavirus treatment might limit plasma availability for people managing chronic diseases.
Early feedback from ECRI internal stakeholders revealed that results from CP studies were encouraging. They noted that CP might improve outcomes in patients with severe COVID-19 by reducing death rates and potentially reducing the need for mechanical ventilation. However, the studies also present substantial risks of bias that could affect interpretation and slow down trials. Controlled studies are needed to make better comparisons on treatments and outcomes.
Stakeholders also raised concerns that the intensive resources needed for this treatment, as well as costs of recruiting CP donors and collecting, processing, and administering therapy, might limit diffusion. Limited availability of CP early in the pandemic might create health disparities. But CP is expected to become more available over time as more people contract and recover from coronavirus infections.
- Area of Potential Impact: Patient outcomes, population health, health care costs
- Category: Treatments
Remdesivir (Veklury) to Treat Severe COVID-19
At a Glance
- Remdesivir is a direct-acting antiviral therapy that inhibits the replication of coronavirus genetic material, potentially reducing severity and duration of disease.
- Mounting clinical trial data suggest that remdesivir might reduce time to recovery and risk of death in patients with moderate to severe COVID-19 after 5 days of therapy.
- Remdesivir is the only drug granted an EUA for treating COVID-19; seeking full FDA approval, the manufacturer submitted a New Drug Application to FDA in August 2020.
- The manufacturer announced a 5-day treatment course of remdesivir costs the US government $2340 and private entities $3120.
Remdesivir (Gilead Sciences) is a direct-acting antiviral prodrug (ie, it converts to a drug in the patient's body). It is intended to inhibit the replication of the novel coronavirus’s genetic material (RNA), thus limiting severity and duration of infection. Mounting clinical trial data suggest remdesivir is effective in reducing time to recovery and risk of death in moderate to severe COVID-19. Data also suggest a 5-day course of treatment might be just as effective as a 10-day course.
Remdesivir received an EUA from the FDA to treat severe COVID-19 on May 1, 2020, and is the only pharmaceutical that has an EUA for treating COVID-19. On August 28, 2020, the FDA granted a broadened EUA for remdesivir to include all hospitalized patients with COVID-19. Gilead is seeking full FDA approval for remdesivir to treat COVID-19 and in August 2020 submitted a New Drug Application to the FDA. If approved, it would be the first FDA-approved treatment for COVID-19. Gilead announced the cost of remdesivir to the US government would be $2,340 and the list price would be $3,120 per 5-day treatment course.
Remdesivir might improve patient health outcomes by improving survival and helping patients recover sooner, and it might decrease health care costs related to hospitalization as a result.
Early feedback from ECRI internal stakeholders suggests that remdesivir is likely to positively improve patient outcomes, considering the drug has an EUA and is already widely available. Its use additionally is likely to increase after the FDA revoked the EUA for hydroxychloroquine and chloroquine. Initial data suggest remdesivir might improve patient health outcomes, although more efficacy and safety data are needed and should include long-term outcomes.
In addition, stakeholders thought remdesivir might reduce health care costs related to hospitalization by reducing length of stay and nonmedication treatment costs.
- Area of Potential Impact: Patient outcomes, health care delivery and process, 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.
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.
|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: September 10, 2020
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