COVID-19

Grand Rounds July 8: Results From the COVID-OUT Trial, a Phase-3 Trial of Outpatient Treatment for COVID-19 Using Metformin, Ivermectin, and Fluvoxamine (Carolyn Bramante, MD, MPH; Thomas Murray, PhD; Jaren Huling, PhD)

Speakers:

Carolyn Bramante, MD, MPH
Assistant Professor, General Internal Medicine and Pediatrics
Core Faculty, Center for Pediatric Obesity Medicine
Core Faculty, Program for Health Disparities Research
University of Minnesota Medical School

Thomas Murray, PhD
Assistant Professor of Biostatistics
Division of Biostatistics
University of Minnesota School of Public Health

Jared Huling, PhD
Assistant Professor of Biostatistics
Division of Biostatistics
University of Minnesota School of Public Health

 

Topic: Results From the COVID-OUT Trial, a Phase-3 trial of Outpatient Treatment for Covid-19 Using Metformin, Ivermectin, and Fluvoxamine
Date: Friday, July 8, 2022, 1:00-2:00 p.m. ET

 

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May 20, 2022: Long-COVID Studies Within the RECOVER Platform (Upinder Singh, MD)

Posted on by Elizabeth Mccamic

Speaker

Upinder Singh, MD
Professor and Division Chief
Division of Infectious Diseases and Geographic Medicine
Stanford University School of Medicine

 

 

Keywords

COVID-19, Long-COVID, EHR

Key Points

  • The definition of Long-COVID has not been generalized yet. Long-COVID can be defined as any symptoms that are present after more than 4 weeks or symtoms that are ongoing after more than three months or 12 weeks. Long-COVID is head to toe, any symptom can be included but did not have to be present when patient had COVID.
  • Up to 30 percent of individuals get Long-COVID, including after severe disease and hospitalization, mild infection, and asymptomatic infection. Some risk factors for Long-COVID include older adults, high BMI, female, more than 5 symptoms when infected. People who are vaccinated are at risk for Long-COVID. The odds of having symptoms are reduced 1 month after infection.
  • The goal of the Researching COVID to Enchance Recovery (RECOVER) study is to improve understanding of and develop strategies to treat and prevent post-acute manifestations of SARS-CoV-2 infection through a multi-pronged research framework. It is an ambi-directional, longitudinal meta-cohort study with nested case control studies. All participants will be followed prospectively under a single main protocol, and there is a flexible study design.
  • RECOVER includes adult, pediatric, pregnant populations and will analyze data from millions of electronic health records. The study is enrolling patients during acute and post-acute phases of infection at 15 sites, with sites in every state. There is also an autopsy phase of the study. Participants are followed over four years.
  • RECOVER will integrate real-world data through the electronic health record that will be pulled into the RECOVER Cohort Study Protocol and will use Mobile Health Data.
  • The Stanford University site has enrolled about 38 percent of its goal, and the majority are acutely infected individuals. Stanford is seeing more women enrolling than men, and about 50 percent are underrepresented in biomedical research. A Long-COVID clinic was established in May 2021.
  • There are many challenges including identifying negative controls and if there will continue to be people who have not had COVID after the various surges of infection. Healthcare systems are stretched and providers are fatigued. It’s a complex trial with an evolving protocol; however, there’s been high interest in the study. The study is aligned with clinical efforts and the Long-COVID clinic. RECOVER will have clinical trials beginning at the end of 2022

Discussion Themes

– Harvard is the DRC for the study and they are developing CDEs for Long-COVID.

– We may not get the perfect epidemiology of Long-COVID because even as we started enrolling, the epidemic has changed and people are getting 1 or 2 boosters.

– All therapeutics should be looking at the long-standing consequences as well as preventing hospitalization and death.

Read more about the study.

Tags

#pctGR, @Collaboratory1

May 18, 2022: This Week’s COVID-19 Grand Rounds to Explore Long COVID in the RECOVER Platform

Posted on by Damon Seils

Headshot of Dr. Upinder SinghIn this Friday’s COVID-19 Grand Rounds, Dr. Upinder Singh of Stanford University will present “Long-COVID Studies Within the RECOVER Platform.” The Grand Rounds session will be held on Friday, May 20, at 1:00 pm eastern. The National Institutes of Health (NIH) created the RECOVER (Researching COVID to Enhance Recovery) Initiative to learn about the long-term effects of COVID.

The NIH Pragmatic Trials Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

Join the online event.

May 10, 2022: Pragmatic Trials Learn From Disruption in the COVID-19 Pandemic

Posted on by Damon Seils

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in April, Dr. Emily O’Brien and Dr. Adrian Hernandez discussed challenges for pragmatic trials during the COVID-19 pandemic and lessons for the future of the healthcare system.

“We certainly did see some degree of disruption, but I was impressed by the flexibility in the ability to adapt that all of our NIH Collaboratory Trial teams showed,” said O’Brien. “Some of them mentioned the support of having the Cores and consultations with experts in real time to be able to make adjustments,” she said.

O’Brien is a an associate professor in population health sciences at Duke University and a cochair of the NIH Collaboratory’s Patient-Centered Outcomes Core. Hernandez, the executive director of the Duke Clinical Research Institute, is a co–principal investigator of the program’s Coordinating Center. View the full interview.

O’Brien and her colleagues at the NIH Collaboratory Coordinating Center conducted a brief survey about the impacts of the pandemic on the NIH Collaboratory Trials, such as challenges they encountered, solutions they implemented, and any new measures the study teams started using.

“The impacts on the NIH Collaboratory Trials [included] research staff being redeployed to COVID-19 studies or clinician-scientists moving into predominantly clinical care roles as opposed to research roles,” O’Brien explained. “The most obvious impact of those changes was delays across projects. It took longer to get things done, to enroll patients. That was felt pretty universally by our projects, although there were several projects that were further along, had enrollment mechanisms that were in place and already up and running that were less impacted by those delays,” she said.

Some study teams also reported a renewed commitment from their partnering healthcare systems to work together as they encountered challenges in trial implementation.

Hernandez added, “For many studies, we thought they would actually stop. And for traditional trials, that’s what happened. But for [the NIH Collaboratory Trials], since they’re closer, more embedded within healthcare systems, part of the delivery process, they were able to flex because by nature they have to for any environment that changes.”

When asked what the COVID-19 pandemic has taught about what is needed for the future, Hernandez said, “It’s not too different than, say, what we have with the Defense Production Act…. What we need is essentially the equivalent of that, a ‘Pandemic Response Production Act,’ so that healthcare systems can be organized, coordinated to generate evidence around what’s needed for the response.”

April 29, 2022: BP Track: National Surveillance for Blood Pressure Control and Related Process Metrics Using PCORnet (Mark J. Pletcher, MD, MPH; Rhonda Cooper-DeHoff, PharmD, MS; Alanna M. Chamberlain, PhD, MPH)

Posted on by terren.green@duke.edu

Speakers

Mark J. Pletcher, MD, MPH
Professor of Epidemiology and Biostatistics and Medicine
University of California, San Francisco

Rhonda Cooper-DeHoff, PharmD, MS, FAHA, FACC, FCCP
Association Professor and Research Foundation Professor
University of Florida College of Pharmacy

Alanna M. Chamberlain, PhD, MPH
Associate Professor of Epidemiology
Mayo Clinic

 

 

Keywords

Blood pressure; PCORnet; Common data model; BP MAP; BP Track; BP Home; COVID-19

 

Key Points

  • Uncontrolled blood pressure (BP) is the leading preventable cause of death in the US, but treatment methods and monitoring metrics are not consistent or clear across patients and healthcare systems.
  • PCORnet is made up of many health systems across the country. Varying types of electronic health record (EHR) data from these health systems are combined into a common data model.
  • The BP Control Laboratory, funded by PCORnet, used surveillance and efficient pragmatic randomized controlled trials to improve BP control in the US. Three projects were funded: BP Track, BP MAP, and BP Home.
  • BP Track leveraged the PCORnet common data model to create 10 blood pressure control metrics.
  • BP levels in the BP Tack study were fairly stable and controlled from 2017 to 2019, prior to the COVID-19 pandemic.
  • BP Track saw a substantial decrease in BP control during the COVID-19 pandemic that has not rebounded to pre-pandemic levels.

Discussion Themes

– The next iteration of the BP Track study hopes to collect data at the individual patient level in order to do individual risk modelling.

– The decrease in BP control during the pandemic may have future implications for increased cardiovascular disease.

Read more about the results from the BP Track study.

Tags

#pctGR, @Collaboratory1

April 8, 2022: COVID-19 Surveillance in PCORnet: Year 2 Update (Jason Block, MD, MPH; Thomas W. Carton, PhD, MS)

Posted on by terren.green@duke.edu

Speakers

Jason Block, MD, MPH
Associate Professor
Harvard Pilgrim Health Care Institute
Harvard Medical School

Thomas W. Carton, PhD, MS
Chief Data Officer
Louisiana Public Health Institute

 

 

Keywords

PCORnet; COVID-19; Electronic health record (EHR); Surveillance data

 

Key Points

  • PCORnet is a national network of 66 million people with EHR-derived data available for research.
  • After significant database modifications to effectively include COVID-19 related data, the CDC PCORnet COVID-19 project began in April 2020 with the first query. 43 participating institutions update data monthly.
  • There have been 40 queries of the PCORnet COVID-19 data completed to date looking at descriptive trends of COVID-19 by care setting and demographics, vaccinations, chronic disease, and treatments.
  • PCORnet COVID-19 data tracks percent hospitalized and relative risk of testing positive for COVID-19 by race over time.
  • Data also shows treatment disparities with monoclonal antibodies over time by race and ethnicity. White patients or non-Hispanic patients who tested positive for COVID-19 were more likely to be treated with monoclonal antibodies than any other race or ethnicity.
  • PCORnet COVID-19 data have also been used to investigate myocarditis and pericarditis after both COVID-19 vaccination and COVID-19 infection. Males ages 12 to 29 have increased risk of cardiac complications after COVID-19 infection compared with COVID-19 vaccination.
  • PCORnet is evolving to improve the capture of information, advance analytics, and provide better collaboration between federal public health and PCORnet investigators.

Discussion Themes

    • Complete surveillance data is difficult to obtain when not all testing or vaccination is being reported.
    • State vaccination data does not always get added the EHR until the patient has another primary care encounter.
    • The ability to continue doing this kind of work relies on a national public health infrastructure.

Read more about PCORnet.

Tags

#pctGR, @Collaboratory1

April 6, 2022: COVID-19 Surveillance in PCORnet to Be Featured in Grand Rounds This Week

Posted on by Damon Seils

Headshots of Dr. Jason Block and Dr. Thomas CartonIn this Friday’s COVID-19 Grand Rounds session, Dr. Jason Block of Harvard Medical School and Dr. Thomas Carton of the Louisiana Public Health Institute will present “COVID-19 Surveillance in PCORnet: Year 2 Update.”

The Grand Rounds session will be held on Friday, April 8, at 1:00 pm eastern. Join the online meeting.

The NIH Pragmatic Trials Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency. This week’s session will be the second presentation by Dr. Block and Dr. Carton about PCORnet’s COVID-19 surveillance. Access the previous session from June 5, 2020.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

Grand Rounds April 8: COVID-19 Surveillance in PCORnet: Year 2 Update (Jason Block, MD, MPH; Thomas W. Carton, PhD, MS)

Speaker:

Jason Block, MD, MPH
Associate Professor
Harvard Pilgrim Health Care Institute
Harvard Medical School

Thomas W. Carton, PhD, MS
Chief Data Officer
Louisiana Public Health Institute

Topic: COVID-19 Surveillance in PCORnet: Year 2 Update
Date: Friday, April 8, 2022, 1:00-2:00 pm ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

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March 24, 2022: ACP-COVID Intervention Associated With Higher Rates of Advance Care Planning

Posted on by Damon Seils
Headshots of Dr. Angelo Volandes, Dr. James Tulsky, and Sophia Zupanc
Left to right: Dr. Angelo Volandes, Dr. James Tulsky, and Sophia Zupanc

A program consisting of video decision aids for patients and communication skills training for clinicians was associated with higher rates of documentation of advance care planning among older adults, especially African American and Hispanic patients, in a recent study from the NIH Pragmatic Trials Collaboratory.

The COVID-19 pandemic has led to disproportionately higher death rates among older adults and racial and ethnic minority groups. Improving access to advance care planning for these groups, as in other high-risk populations, could help patients receive care that reflects what matters most to them.

The Advance Care Planning: Communicating With Outpatients for Vital Informed Decisions (ACP-COVID) study was a pre-post, open-cohort nonrandomized controlled trial comparing rates of advance care planning documentation among older patients in an ambulatory care network of 22 clinics in the New York City metropolitan area. Outcomes were measured during a 6-month pre–COVID-19 baseline period, a 6-month period during the first wave of the COVID-19 public health emergency, and a 6-month intervention period.

The study’s results were published in JAMA Network Open.

Video decision aids were shared with all patients 65 years or older up to 2 weeks before an in-person or telehealth appointment in the participating clinics. The videos addressed choosing a healthcare proxy, having an advance care planning conversation, and information about COVID-19 and vaccinations. Communication skills training was offered to all clinicians in the practices.

Rates of advance care planning documentation were much higher during the intervention period compared with the 2 other study periods. In addition, African American and Hispanic patients were more likely than non-Hispanic White patients to have advance care planning documentation during the intervention period, groups which also had higher exposure to serious COVID-19 illness during the study.

Watch a recent COVID-19 Grand Rounds session about the ACP-COVID study.

ACP-COVID was supported within the NIH Pragmatic Trials Collaboratory by the NIH Common Fund through a cooperative agreement for the ACP-PEACE NIH Collaboratory Trial from the National Institute on Aging and by supplemental funding from the Office of Strategic Coordination within the Office of the NIH Director. Learn more about ACP PEACE.

March 18, 2022: Early Treatment of COVID-19: The TOGETHER Adaptive Platform Trial (Edward Mills, PhD, FRCP; Craig Rayner, PharmD)

Posted on by terren.green@duke.edu

Speakers

Edward Mills PhD, FRCP
Professor, McMaster University

Craig R Rayner FRCP Edin PharmD MBA
Certara Distinguished Scientist
Adjunct Associate Professor, Monash University

Keywords

COVID-19; Ivermectin; TOGETHER trial; Patient engagement; Adaptive platform trial

Key Points

  • The TOGETHER trial is a randomized adaptive platform trial investigating 11 different treatments for COVID-19 including Ivermectin.
  • Initial in vitro experiments of Ivermectin in April of 2020 showed promising results, but many of those original papers were later retracted.
  • The TOGETHER trial used PBPK modelling to determine trial dose regimen. The trial started with 1 dose and later moved to 3 doses.
  • The primary outcome of the TOGETHER trial was emergency room visits due to COVID-19 or hospitalization due to the progression of COVID-19.
  • No evidence was found of treatment effect for ivermectin compared to placebo, but a small treatment effect cannot be ruled out. It may have an effect for a subgroup of patients.

Discussion Themes

A low confidence interval could signal that the trial was stopped too early.

Building trust within the community is key to the success of a trial. Recruitment is difficult if the patients don’t trust the trial or researchers.

Read more about the TOGETHER trial.

 

 Tags

#pctGR, @Collaboratory1