Research Studies

Ongoing Sponsored Clinical Trials

  • PI: Sarah Watkins, DO
  • Co-PI: Edward Michelson, MD
  • Study Purpose: Evaluate the efficay of IV varespladib in addition to SOC in subjects bitten by venomous snakes 
Inclusion Exclusion

Age ≥ 18 with venomous snakebite

 History of or is suspected to have cerebrovascular accident or intracranial bleeding of any kind, acute coronary syndrome, myocardial infarction, or severe pulmonary hypertension.

Category 1: The patient is enrolled within 5 hours of venomous snake bite or symptom onset with an SSS score* of >2 in one system and >1 in another system (2+1)

 OR 

Category 2: The patient has a suspected or confirmed bite from an elapid and is enrolled within 10 hours of bite or symptom onset with moderate to severe cranial nerve or skeletal muscle weakness**

 History of inherited bleeding or coagulation disorder

* Only local wound, pulmonary, cardiovascular, hematologic, or nervous system scores qualify for SSS inclusion criteria. GI and Renal scores are not used for inclusion. 

 

** Isolated ptosis does not meet the definition of moderate to severe neurotoxicity for enrollment. 

 At Screening visit using anticoagulants or other low molecular weight heparin or any antiarrhythmic drugs within 14 days prior to treatment
Willing (or LAR is willing) to provide informed consent prior to initiation of any study procedures History of chronic liver disease 
  Reports or has known pre-existing renal impairment or chronic kidney disease.
  Has a known allergy or significant adverse reaction to varespladib or varespladib-methyl.
  Considered by the Investigator to be unable to comply with protocol requirements due to geographic considerations, psychiatric disorders, or other compliance concerns
  Pregnant, has a positive urine or serum human chorionic gonadotropin (hCG) pregnancy test or not willing to use a highly effective method of contraception for 14 days after initial treatment, or is breast-feeding.
  • PI: Leo Mercer, MD
  • Co-PI: Edward Michelson, MD
  • Study Purpose: Investigate the efficacy and safety of a single IV infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and or predicted to receive a large volume blood product transfusion
Inclusion Exclusion
Estimated or actual age ≥ 15 years AND  Estimated or actual weight ≥ 50 kg (110 lbs) Cardiopulmonary resuscitation for ≥ 5 consecutive minutes at any time before randomization
Traumatic injury with: (a) confirmed or suspected acute major bleeding; and / or (b) Revised Assessment of Bleeding and Transfusion (RABT) score ≥ 2 Isolated penetrating or blunt cranial injury, or exposed brain matter
Activation of massive transfusion protocol Known anticoagulation treatment or a history of a TEE, within the past 3 months
At least 1 unit of blood product spiked (transfusion bag connected to an IV fluid line and ready to start) Isolated burns estimated to be > 20% total body surface area or suspected inhalational injury
Anticipated start of IP infusion within 90 minutes after arrival at the hospital Ground level fall
  Drowning or hanging
  Subject transferred from another hospital
  Known heparin-induced thrombocytopenia
  Known hereditary disorders that significantly increase prothrombotic risk such as hereditary antithrombin III deficiency, Factor V Leiden, etc.
  Known or suspected pregnancy
  Known anaphylactic or severe systemic reactions to BE1116 or any components in BE1116 including heparin, Factors II, VII, IX, X, Proteins C and S, antithrombin III, and human albumin
  Prisoner
  Known “Do Not Resuscitate” order
  Subject or a family member voiced an objection to participation in the trial or were wearing an “opt-out” bracelet
  Known participation in another interventional clinical study except with prior documented agreement from the sponsors
  Known treatment with any prohibited medications including 3F-PCC, 4F-PCC, aPCC (FEIBA), and / or Factor VIIa after trauma and prior to randomization

Ongoing Investigator-Initiated Studies

  • PI: Edward Michelson, MD
  • Co-PI’s: Jennifer Asante, MD, Akane Fukuda, MD & Elioenai Morales, MD
  • Study Purpose: Determine if the addition of a single dose of 8mg of dexamethasone after a head nerve block is associated with decreased recurrence of headache within 72 hours 
Inclusion Exclusion

Age >18 (including pregnant patients)

 Head trauma

Meet ICHD-3 Migraine Headache Criteria

 Suspicion of secondary headache (i.e. stroke, known tumor, glaucoma)

Had a minimum 5-point reduction in headache intensity after nerve block(s) or with a post-block score of 0 to 2

 Headache in the setting of viral syndrome
Nerve block performed with bupivacaine 0.5% Chronically on steroids
  Known allergy to dexamethasone
  Unable to reach the patient by phone or text
  Gestational diabetes or other uncontrolled diabetes
  Known to be immunocompromised

Completed Sponsored Clinical Trials

  • PI: Edward Michelson, MD
  • Co-PI’s: Erik Nordquist, MD & Sarah Watkins, DO
  • Study Purpose: To evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization of COVID-19. 
Inclusion Exclusion

At least 30 years old

 Participation in another clinical trial

Confirmed SARS-CoV-2 infection or reinfection

 Current or recent (within 14 days) use of study drug or study drug/device combination

Two or more current symptoms of acute COVID- 19 infection for ≤7 days

 Hospitalization within 10 days of screening for COVID-19 infection
* Pregnant participants can be included* Known contraindications to study drugs
  Previous or current enrollment in the ACTIV-6 trial
  • P.I. Edward Michelson, MD
  • Study Purpose: This study will evaluate the performance of TriVerity to diagnose bacterial and viral infections.
Inclusion Exclusion

Age >18

 Patients receiving palliative or hospice care, or those receiving limited interventional care

Suspected acute infection (e.g., respiratory, urinary, abdominal, skin & soft-tissue infection, meningitis/encephalitis, or any other infection), and at least one of the signs in Table 1 

OR

Suspected sepsis of any cause as defined by a blood culture order by the treating physician and at least two of the signs in Table 1. 

 Prisoners, mentally disabled, or unable to give consent. 

Table 1: Vital Signs and Inclusion Criteria 

 

Heart rate                     >90 beats/ minute 

 

Temperature                     >38 C or <36 C 

 

Respiratory Rate                     >20 breaths / minutes                       

                                                      or PaO2 of <60 mmHg      

                                                      or SpO2 <90% 

 

Systolic blood pressure            <100 mmHg 

 

Altered mental status               Per clinical exam 

Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to the emergency department study visit 

**Participants will not be excluded for use of:

 

a. Antiviral treatment for HIV infection and hepatitis B and hepatitis C 

b. Topical antibiotics, topical antiviral or topical antifungal agents 

c. Anti-herpes prophylaxis aiding suppression of a recurring herpes infection 

d. Peri-operative (prophylactic) antibiotics 

e. A single dose of antimicrobials during the present ED visit (<10h before blood draw 
  Patients receiving experimental therapy or already enrolled in an interventional clinical trial 
  Patients previously enrolled in the present clinical trial
  • P.I. Edward Michelson, MD
  • Study Purpose: We are using a device known as BrainScope, a portable EEG device, to determine if the likelihood of a structural brain injury being present and potentially visible on CT scan. This is done to add confidence to the treating physician's decision.
Inclusion Exclusion

Age 35-85 years old

 Patient had head CT for current head injury prior to study screening

Admitted to ED with traumatic, closed head trauma within 72 hours of injury

 Has open head injury

Glasgow Coma Score (GCS) of 14-15 at time of assessment

Presence of forehead, scalp, earlobe or skull abnormalities
If the patient needs a CT STATà Do not delay, get scan!  History of dementia, Parkinson's disease, multiple sclerosis, brain tumor, or brain surgery
If the patient needs head CT, but is stable to wait, then call research staff.  History of stroke with neurologic deficit within last year
  Currently receiving dialysis or in end-stage renal disease
  Current condition is 'critical' in opinion of investigator
  Has suffered multi-trauma and requires hospitalization
  Taking anti-platelet medications or anti-coagulants (other than aspirin)
  Receiving procedural sedation medications
  Active fever greater than 37.7C (100F)
  Requires advanced airway management
  Pregnant

Completed Investigator-Initiated Studies

  • PI: Edward Michelson, MD
  • Study Purpose: Since the neurologic symptoms of some COVID patients resemble those of patients with concussion, the aim of this study is to identify EEG and cognitive function (brain fog) changes in long COVID patients.
Inclusion Exclusion

Age 18-85

 Any abnormality that would prevent electrodes from being placed in correct positions, e.g., head or face trauma

GCS of 14-15

 Unable to provide consent due to acute or chronic drug/alcohol use

COVID-19 Diagnosis

 Hypoxia that cannot be corrected to a saturation level of 92% by nasal cannula or simple mask supplementation.
Hemodynamically stable Currently receiving sedation medications
Able to provide consent and cooperate in EEG and neurometric testing  
  • PI: Edward Michelson, MD
  • Co-PI: Erik Nordquist, MD, Sarah Watkins, DO, Susan Watts, PhD & John Miller, PharmD
  • Study Purpose: We seek to use Cromolyn, traditionally described as a mast cell stabilizer, with standard COVID-19 treatment to improve symptoms and reduce the number of days to improved quality of life.
Inclusion Exclusion

Age 18-80

 Allergy or previous adverse reaction to cromolyn sodium

Confirmed diagnosis of COVID-19 infection

 Immunocompromised due to current use of immunosuppressive drugs or chemotherapy, have a history of HIV/organ transplant/ active hepatitis B or C

Glasgow Coma Score (GCS) of 14-15 at time of assessment

 Currently on oxygen supplementation greater than low flow nasal cannula
Demonstrate COVID-19 symptoms. First symptoms within 7 days of randomization Have DNR status or not expected to survive >7 days.
Able to provide informed consent On hemodialysis or peritoneal dialysis
Must need supplementary oxygen of no more than 4L of oxygen (INPATIENT ONLY)/ No O2 required (OUTPATIENT) Experiencing shock (on vasopressors) or multiple organ dysfunction or failure
Current estimated PaO2/FiO2 ratio be between 170-280 (INPATIENT) / PaO2/FiO2 ratio greater than 304 (OUTPATIENT) Are co-infected with influenza A or B
Admission chest x-ray demonstrating multilobar ground glass infiltrates consistent with COVID-19 pneumonia (INPATIENT ONLY) History of DVT or PE within last 12 weeks
Must be enrolled within 36 hours of hospital admission (INPATIENT ONLY) Currently pregnant or nursing
  Participating in another therapeutic trial

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