Active COVID-19 Clinical Research Trials
The Albert Einstein College of Medicine and Montefiore Medical Center are at the forefront with regard to COVID-19 therapeutic clinical research. A list of those trials and links to their related CT.GOV information, may be accessed by clicking here. Some examples of active protocols include:
COVID-19 Convalescent Plasma: In a March 13 “Viewpoint” article in The Journal of Clinical Investigation, Dr. Liise-Anne Pirofski, Chief of the Department of Medicine Infectious Diseases Division at Einstein and Montefiore with Dr. Arturo Casadevall from Johns Hopkins University, proposed that a treatment using antibodies in serum from convalescent COVID-19-infected individuals could rapidly be developed to prevent and treat COVID-19 infection and urged that this strategy be evaluated in a clinical trial. This resulted in the National COVID-19 Convalescent Plasma Project. Dr. Pirofski also holds the IND for a randomized therapeutic clinical trial using convalescent being performed in conjunction with NYU. She discusses the use of convalescent plasma on her podcast interview with The Lancet and CNN. Additional coverage of Dr. Pirofski on COVID-19 includes: USA Today, Nature, The Atlantic, Wall Street Journal (subscription required), Associated Press, NPR, LA Times, NBC News, CBS News.
Remdesivir: Dr. Barry Zingman, Professor of Medicine at Einstein, led Montefiore’s NIH Adaptive COVID Treatment Trial (ACTT) of remdesivir vs placebo which enrolled 91 patients. This first phase of the ACTT study is now closed to new enrollments at Montefiore/Einstein, which was one of only two sites in New York City. The next phase (ACTT II), a double-blind, controlled trial of remdesivir, baricitinib (JAK 1/2 inhibitor), or the combination vs placebo, is expected to open in approximately 1-2 weeks.
Sarilumab: Dr. Michelle Gong, Chief of the Department of Medicine Critical Care Division and Pulmonary Medicine Division is the Site PI for an adaptive, randomized, placebo-controlled clinical trial assessing the safety and efficacy of the IL-6 receptor antibody sarilumab to treat severe or critical COVID-19 in hospitalized adults. This trial is evaluating the impact of sarilumab on fever and patients' need for supplemental oxygen and the improvement in longer-term outcomes including preventing death and reducing the need for mechanical ventilation, supplemental oxygen and/or hospitalization.
Expedited Review Process
To assist faculty, Einstein and Montefiore have developed a centralized COVID 19 trial review process for the scientific review and prioritization of COVID 19 trials. The Dean’s Office has assembled a faculty committee to evaluate proposed clinical trials for basic feasibility, such as: scientific rationale, risks and potential benefit, robustness of the proposal/protocol with respect to the objectives, safety and efficacy endpoints. The committee will also evaluate ongoing research that may compete with or be complementary to the proposed research - and assess alignment with organizational priorities and capabilities.
The clinical trials that are determined to be potentially promising will be sent to potential PI’s and Chairs to determine interest and operational feasibility. Please note that projects will still require all institutional approvals (e.g., IRB, OGS, OCT, etc.) prior to commencement.
Please submit COVID-19 Clinical Trial proposals to: email@example.com
Data and Informatics
A big-data platform has been developed to help Montefiore-Einstein clinicians and researchers maximize the value of clinical information, particularly relative to the COVID-19 pandemic. For more information regarding access, please contact firstname.lastname@example.org. Please note that any request for data requires a protocol and IRB review, even if you expect the project to qualify as 'exempt.' Additional questions on how the Center for Health Data Innovations can help you with your project should be directed to email@example.com.
Clinical Trial Implementation:
An expedited process has been developed for the review and approval of COVID -19 human subject protocols. For investigators who need assistance expediting approval and initiation of trials, please note the following:
Institutional Review Board (IRB)
- To open a new study related to COVID-19, submit your protocol as per standard IRB procedure and then email firstname.lastname@example.org to alert the IRB of your submission, with the words “COVID-19 Protocol” in the subject line.
- To amend an existing protocol to include COVID-19, please contact the OHRA for guidance (email@example.com).
- If the proposed protocol will be arranged as a multi-site study under a Single IRB arrangement, please submit a request via: singleIRB@einsteinmed.org.
- To access IRB FAQ’s related to COVID research, please click here.
Office of Clinical Trials (OCT)
- The Office of Clinical Trials (OCT) is the central administrative office for private industry funded clinical research for Montefiore Medical Center and the Albert Einstein College of Medicine. They can be reached at OCT@montefiore.org.
- For COVID 19 trials, services include expedited contract and budget development and finding research coordinator support for COVID 19 clinical trials.
Research Agreement Request Portal (RARP)
- All research related regulatory, legal and compliance documents related to human subject research, should be submitted via the RARP
- Research Related Legal Documents include inter-institutional collaboration agreements, confidential disclosure agreements, material transfer agreements, data use agreements, sponsor agreements, etc.
- Research related agreements require review and approval by institutional officials prior to sending or receiving confidential information, materials, and/or data with another outside party, including collaborations or sub-contract grant provisions.
Specifically, agreements that involve the following, must be submitted to the RARP portal:
- Human subject participation
- Human-derived data (de-identified, Limited Data Set, or PHI)
- Human-derived specimens/materials
- If you have any immediate questions about the process, please email firstname.lastname@example.org
Office of Biotechnology and Business Development
For Industry-Sponsored Research Agreements that are managed by the Office of Biotechnology and Business Development, please note:
- For researchers with an active or contemplated industry-sponsored research agreement, please review the work plan, budget, and milestones. If there are any significant changes as a result of the COVID-19 situation that may impact reporting, invoicing or other deliverables related to the industry sponsor (i.e., requiring a new postdoc, conducting new animal experiments, etc.), please notify OBBD to review and determine the best course of action.
- For these matters, please email email@example.com with the subject “SRA Impacted by COVID-19.”