COVID-19 Related Research
While the COVID-19 pandemic has presented the medical and scientific community with unrelenting and unparalleled challenges, the unique nature of the Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2), which causes COVID-19, provides for wide-ranging and potentially impactful areas of scientific exploration and understanding.
COVID-19 Global Rheumatology Alliance Registry
- Type of trial: observational (registry)
- PI: Dr. Virginia Steen and rheumatology faculty and fellows at GT and WHC
- Description: Any COVID 19 patient that has a rheumatic /autoimmune disease. This study is trying to understand how our patients do as far as their high risk medication and underlying diseases.
- Contact: Virginia Steen (steenv@georgetown.edu ) or Peter Ban, MD (fellow) (Byung.H.Ban@gunet.georgetown.edu)
- Start Date: Now (including any prior patients – can be retrospective)
- For DOM Faculty, Staff and Trainees: Please send us the name and medical record number for the Covid 19 patients with any autoimmune disease. We have IRB approval to enter deidentified data into this important rheumatology registry.
COVID-19 Genome Sequencing
- Type of trial: Observational
- PI: Dr. Jose Vargas
- Description: National study in collaboration with the NIH to do whole genome sequencing, RNA sequencing and proteomic analysis on COVID19 positive patients. Our hypothesis is that clinical heterogeneity in response to viral infection is at least in part driven by genomic factors, current nationwide target is 2500 patients although this may increase depending on funds availability. The study consists of one blood draw with the tubes being mailed to NIH for processing.
- Contact: Jose Vargas (Jose.d.vargas@medstar.net)
- Start Date: Currently Under IRB Review
- For DOM Faculty, Staff and Trainees: Once study is approved we would like to for DoM faculty/trainees to be aware of the study as our study coordinator will be contacting primary team to asses feasibility of consent
Study to Assess Safety and Efficacy of ANG-3777 in Patients Hospitalized with COVID-19 pneumonia
- PI: Dr. Princy Kumar and Dr. Joseph Timpone
- Description: Primary objective is to assess the clinical efficacy of ANG-3777 relative to standard of care in reducing the severity and progression of pulmonary dysfunction and mortality in adult patients hospitalized with COVID-19 pneumonia.
- Contact: Dr. Kumar (KUMARP@gunet.georgetown.edu) or Dr. Timpone (TimponeJ@gunet.georgetown.edu)
Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects with Severe Coronavirus Disease (COVID-19) (i-Mab)
- PI: Dr. Princy Kumar and Dr. Joseph Timpone
- Description: Primary objective is To evaluate the safety and efficacy of TJ003234 in subjects with severe COVID-19 with supportive care
- Contact: Dr. Kumar (KUMARP@gunet.georgetown.edu) or Dr. Timpone (TimponeJ@gunet.georgetown.edu)
Safety and Efficacy Trial of BHV-3500 (Vazegepant) Intranasal (IN) for COVID-19 Infected Hospitalized Patients Requiring Supplemental Oxygen
- PI: Dr. Princy Kumar and Dr. Joseph Timpone
- Description: Primary objective is to evaluate the safety and efficacy of vazegepant (BHV-3500) compared with placebo in subjects hospitalized with COVID-19 infection requiring supplemental oxygen
- Contact: Dr. Kumar (KUMARP@gunet.georgetown.edu) or Dr. Timpone (TimponeJ@gunet.georgetown.edu)
Study To Investigate The Pharmacodynamics, Pharmacokinetics, Safety, And Efficacy Of 8 Mg/Kg Or 4 Mg/Kg Intravenous Tocilizumab In Patients With Moderate To Severe Covid-19 Pneumonia (CA42481A)
- PI: Dr. Princy Kumar, Dr. Joseph Timpone, and Dr. Deepa Lazarous
- Description: This Phase II study will investigate the pharmacodynamics, pharmacokinetics, safety, and efficacy of tocilizumab (TCZ) at two different doses (8mg/kg and 4mg/kg) in combination with standard-of-care (SOC) treatment in hospitalized patients with moderate to severe COVID-19 pneumonia.
- Contact: Dr. Kumar (KUMARP@gunet.georgetown.edu), Dr. Timpone (TimponeJ@gunet.georgetown.edu), or Dr. Lazarous (DL28@gunet.georgetown.edu)
Study to assess the efficacy and safety of ruxolitinib in patients with COVID-19-induced cytokine storm who require invasive mechanical ventilation (RUXCOVID-DEVENT)
- PI: Dr. Princy Kumar, Dr. Joseph Timpone, and Dr. Tunay Kuru
- Description: The purpose of this study is to evaluate the efficacy and safety of the Janus Kinase (JAK) 1/2 inhibitor ruxolitinib in the treatment of patients with COVID-19-induced cytokine storm who require mechanical ventilation.
- Contact: Dr. Kumar (KUMARP@gunet.georgetown.edu), Dr. Timpone (TimponeJ@gunet.georgetown.edu), or Dr. Kuru (TK53@gunet.georgetown.edu)
Convalescent Plasma to Stem Coronavirus (CSSC-001)
- PI: Dr. Princy Kumar and Dr. Seble Kassaye
- Description: A Randomized Controlled Double Blinded Phase 2 Study Comparing the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
- Contact: Dr. Kumar (KUMARP@gunet.georgetown.edu) or Dr. Kassaye (Seble.G.Kassaye@gunet.georgtown.edu)
REMAP COVID
- PI: Dr. Anne O’Donnell
- Status: Waiting to receive contract
- Contact: Dr. O’Donnell (ODONNELA@gunet.georgetown.edu)
ALXN1210-COV-305
- PI: Dr. Catherine Broome
- Status: Enrolling
- Contact: Dr. Broome (Catherine.M.Broome@gunet.georgetown.edu)
RAPID COVID COAG
- PI: Dr. Alex Montero and Dr. Craig Kessler
- Status:
- Contact: Dr. Montero (Alex.R.Montero@gunet.georgetown.edu) or Dr. Kessler (KESSLERC@gunet.georgetown.edu)
Remdesivir/JAC 2 Agent
- PI: Dr. Princy Kumar
- Status: New
- Contact: Dr. Kumar (KUMARP@gunet.georgetown.edu)
Immunomedulatory COVID Redcap Database
- PI: Dr. Anne O’Donnell
- Status: Data entry complete
- Contact: Dr. O’Donnell (ODONNELA@gunet.georgetown.edu)
Medstar COVID ED/Inpatient Registry
- PI: Dr. Nathan Cobb
- Status: Data entry ongoing
- Contact: Dr. Cobb (Nathan.K.Cobb@gunet.georgetown.edu)