The NIA IMPACT Collaboratory will host a special edition of its Grand Rounds series to address the COVID-19 crisis in nursing homes.
Drs. David Grabowski and Susan Mitchell of Harvard Medical School and Dr. Vince Mor of Brown University will present “COVID-19 in Nursing Homes: Pragmatic Research Responses to the Crisis.” Drs. Mitchell and Mor are the co–principal investigators of the NIA IMPACT Collaboratory, a national network of pragmatic clinical trials researchers advancing care for persons with dementia and their caregivers.
The NIH 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.
The NIH 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.
Sean Collins, MD, MSc
Professor and Executive Vice Chair
Department of Emergency Medicine
Director, Center for Emergency Care Research and Innovation
Vanderbilt University Medical Center
Topic
Hydroxychloroquine for the Early Treatment of COVID-19 in Hospitalized Adults: A Multicenter Randomized Clinical Trial
Keywords
Coronavirus; Virus pandemic; COVID-19; Randomized controlled trial; Acute respiratory distress syndrome (ARDS); Hydroxychloroquine; FDA; Emergency Use Authorization; ORCHID study
Key Points
Hydroxychloroquine is a biologically plausible agent for early treatment of acute respiratory distress syndrome in patients with COVID-19, but its effects remain to be evaluated in a high-quality, multicenter, blinded, placebo-controlled trial.
In an Emergency Use Authorization, the FDA has encouraged the conduct and participation in randomized controlled clinical trials that may produce evidence concerning the effectiveness of hydroxychloroquine in treating patients with COVID-19.
Trial results of the effects of this agent will be informative, whether showing benefit or harm.
Discussion Themes
The study team for this trial determined that one-to-one randomization would yield the best data quickly.
Efficacy and safety of hydroxychloroquine must be closely monitored in a health setting.
This is not the only study of chloroquine going on around the world; is there any collaboration with other studies?
Because of the urgency of the pandemic, people are collaborating on a level never seen before. We have a common goal and must maintain momentum through accelerating clinical trials with large teams of parallel studies.
Read more about this COVID-19 study at NCT04332991.
The NIH 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.
Using its popular Grand Rounds platform, the NIH Collaboratory Coordinating Center has launched a new effort to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.
Last week on Grand Rounds, we kicked off a vital new COVID-19–focused webinar series with “Clinical Trials in the Time of COVID-19.” Part of the NIH Collaboratory’s weekly Grand Rounds series, this first episode about the COVID-19 emergency featured a discussion with NIH Collaboratory co–principal investigator Dr. Adrian Hernandez, infectious disease clinical researcher Dr. Susanna Naggie, and data science and policy expert Dr. Eric Perakslis.
The special COVID-19–focused webinar series will continue on Grand Rounds in the coming weeks, including the following sessions:
Another research model is to implement direct-to-participant trials that are streamlined, personalized, and potentially safer.
Discussion Themes
Do you anticipate that statisticians will need to account for period effect in later analysis of data (pre/post COVID-19)?
Are there lessons learned from the last epidemics, for example H1N1 or Ebola? How can we deal with global pandemics in the future?
What about clinical trials in the elderly population, given that they are the most vulnerable to the coronavirus and may not be as good with technology as younger participants?
Would it be possible to set up a multisite telehealth-based outbreak learning health unit?
The NIH today announced new guidance describing the flexibility available to recipients who are conducting NIH-funded clinical trials or human subject studies affected by the COVID-19 public health emergency. The new guidance addresses the safety of research participants and research staff, delays in research progress, and unanticipated costs.
Last week, the NIH created a new public web page—Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients—to serve as a central location for information about application deadlines, proposal submission and award management, and flexibility available to applicants and recipients. The page also includes links to COVID-19 information from the NIH, the Centers for Disease Control and Prevention, and the World Health Organization. The web page will be updated as events require.
A new public web page offers guidance and resources for NIH applicants and recipients in response to the COVID-19 public health emergency declared by the Secretary of Health and Human Services.
Information for NIH Applicants and Recipients includes information about application deadlines, proposal submission and award management, and flexibility available to applicants and recipients. The page also includes links to COVID-19 information from the NIH, the Centers for Disease Control and Prevention, and the World Health Organization.
The new web page will be updated as events require.
