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ACTIV4 C (Post-hospital): Tulsa & Bartlesville

  • Purpose:
  • A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge
  • Study Design:
    • Adaptive, prospective, randomized, placebo-controlled platform trial
  • Major Inclusion Criteria:
    • Age ≥ 18 years
    • PCR-positive COVID-19 infection
    • Hospitalized for two or more days
  • Major Exclusion Criteria:
    • Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein thrombosis; atrial fibrillation; mechanical cardiac valve)
    • Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30 days requiring emergency room presentation or hospitalization; major surgery within 14 days; ischemic stroke, intracranial bleed or neurosurgery within 3 months.
    • Platelet count < 50,000/mcL
    • Hemoglobin <8 gm/dL
    • Renal insufficiency (eGFR< 30 mL/min/1.73 m2)
    • Pregnancy
    • Prison inmate
    • Life expectancy less than 90 days
    • Unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol
    • Dual antiplatelet therapy that cannot be discontinued
    • Concomitant need for strong inducers/inhibitors of p-gp or CYP3A4
  • Primary Investigator(s):  Dr. Nicholas Hanna
  • Sub Investigator(s):  Dr. Anuj Malik; Dr. Anderson Mehrle; Mollie Bechtelheimer, APRN; Kari McCracken, PharmD; Stephanie Burns, PharmD           
  • Clinical Research Coordinator:  Melanie Arnold, BSN, RN

Regulatory Specialist: Julie Davenport

ACTIV-2 Outpatient: Tulsa

 
  • Purpose:
    • Adaptive Platform Treatment Trial for Outpatients with COVID-19
    • Study Design:
      • Adapt Out COVID is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of non-hospitalized adults with COVID-19.
      • The trial is a randomized controlled platform that allows agents to be added and dropped during the course of the study for efficient phase II and phase III
    • Major Inclusion Criteria:
      • Adults age ≥ 18 yeats found to be COVID-19 positive who do not require hospitalization due to stable COVID-19 related symptoms status, but have a risk of disease progression due to comorbidities or compromised immunity
      • Symptom start date ≥  7 days prior to screening and randomization
    • Major Exclusion Criteria:
      • Patients who require hospitalization
      • Patients who do not meet criteria for risk of disease progression
    • Primary Investigator(s): Dr. Anuj Malik
    • Sub Investigator(s): 
    • Clinical Research Coordinator: Anna Bryan, BSN, RN-CRC
    • Regulatory Specialist:Sherri Coggin
  • Study Design:
    • Adaptive, prospective, randomized, placebo-controlled platform trial
  • Major Inclusion Criteria:
    • Age ≥ 18 years
    • PCR-positive COVID-19 infection
    • Hospitalized for two or more days

ACTIV-4b Outpatient: Tulsa and Bartlesville

  • Purpose:
    • A Multicenter Adaptive Randomized Double-Blind Placebo Controlled Platform Trial of the Efficacy and Safety of Antithrombotic Strategies in COVID-19 Adults not Requiring Hospitalization at Time of Diagnosis
  • Study Design:
    • An adaptive randomized double-blind placebo-controlled platform trial
  • Major Exclusion Criteria:
    • Patients with a contraindication to or requirement for anticoagulant/antithrombotic therapy are not eligible.
  • Primary Investigator(s): Dr. Nicholas Hanna (Tulsa); Dr. Anderson Mehrle (Bartlesville)
  • Sub Investigator(s): Dr. Anuj Malik
  • Clinical Research Coordinator: Melanie Arnold, BSN, RN (Tulsa); Mary Harris, MSN, RN (Bartlesville)
  • Regulatory Specialist: Julie Davenport

ANNEXa-S: Tulsa

Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Require Urgent Surgery

  • Purpose:
    • Evaluate hemostatic efficacy following andexanetalfa treatment in patients requiring urgent surgery and who have, within 15 hours prior to surgery, received their last dose of apixaban, rivaroxaban, edoxaban or enoxaparin.
  • Study Design:
    • Multicenter, prospective, open label
  • Major Inclusion Criteria:
    • Require urgent surgery within 12 hours of consent
    • Received apixaban, rivaroxaban, edoxaban or enoxaparin within 15 hours prior to surgery
 
  • Major Exclusion Criteria:
    • Acute life-threatening bleeding
    • Surgery requiring cardiopulmonary bypass, intra-aortic catheter or intraoperative use of unfractionated heparin.
    • Acute decompensated CHF, severe sepsis, shock
  • Primary Investigator(s): Dr. Michael Charles
  • Sub Investigator(s): Dr. Errol Gordon; Russell Dixon, PharmD
  • Clinical Research Coordinator: Jane Bryce, PhD, RN, AOCNS
  • Regulatory Specialist: Julie Davenport

ARDS: Tulsa

A Phase 2 randomized, double-blind, placebo-controlled, multi-center trial to assess the efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 or other disorders.

  • Purpose:
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  • Study Design:
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  • Major Inclusion Criteria:
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  • Major Exclusion Criteria:
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  • Primary Investigator(s): Dr. Jill Wenger
  • Sub Investigator(s): Dr. Caleb Severns; Kari McCracken, PharmD
  • Clinical Research Coordinator: Jane Bryce, PhD, RN, AOCNS
  • Regulatory Specialist: Julie Davenport

 

cv-MOBIUS: Tulsa

The Cardiovascular Multi-dimensional Observational Investigation of  the Use of PCSK9 Inhibitors

  • Purpose:
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  • Study Design:
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  • Major Inclusion Criteria:
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  • Major Exclusion Criteria:
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  • Primary Investigator(s): Dr. Nicholas Hanna
  • Sub Investigator(s): Dr. Ravi Kode
  • Clinical Research Coordinator: Jane Bryce, PhD, RN, AOCNS
  • Regulatory Specialist: Julie Davenport

DIAMOND: Bartlesville

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromerfo the Management of Hyperkalemia in Subjects Receiving Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure

  • Purpose:
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  • Study Design:
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  • Major Inclusion Criteria:
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  • Major Exclusion Criteria:
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  • Primary Investigator(s): Dr. Anderson Mehrle
  • Sub Investigator(s): Mollie Bechtelheimer, APRN
  • Clinical Research Coordinator: Mary Harris, MSN, RN

Regulatory

Rigel (FOCUS): Tulsa (Closed to Enrollment)

Double-Blind, Randomized, Placebo-Controlled, Adaptive Design, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects

  • Purpose:
  • Evaluate the efficacy and safety of fostamatinib when used in combination with standard of care (SOC) in patients hospitalized with COVID-19 without respiratory failure and with certain high-risk prognostic factors.
  • Study Design:
    • Double-blind, randomized, placebo-controlled, multi-center, Phase III study
  •  
  • Major Inclusion Criteria:
    • Adult hospitalized COVID-19 patients without respiratory failure needing oxygen therapy.
    • Ordinal scale 5 or 6  on the 8-point scale.
    • High risk category for disease progression
  • Major Exclusion Criteria:
    • Renal or liver impairment
    • Multi-organ failure
    • MI within the past 1 month,  NYHA III or IV, , uncontrolled hypertension
    • Immunomodulatory treatment for COVID-19 within 14 days of enrollment unless SOC
  • Primary Investigator(s):  Dr. Anuj Malik
  • Sub Investigator(s):  Dr. Vishal Mundra
  • Clinical Research Coordinator:   Jane Bryce, PhD, RN, AOCNS
  • Clinical Research Associate: 
  • Regulatory Specialist: Julie Davenport

KINTOR GT0918-US-3002: Tulsa (closed to enrollment)

A Randomized, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects

  • Purpose:
  • Evaluate the efficacy and safety  ofproxalutamide when used in combination with standard of care (SOC) in patients hospitalized with severe COVID-19.
  • Study Design:
    • Double-blind, randomized, placebo-controlled, multi-center, international  Phase III study
  • Major Inclusion Criteria:
    • Adult hospitalized COVID-19 patients
    • Severe disease, requiring supplemental oxygen, high-flow or non-invasive ventilation
  • Major Exclusion Criteria:
    • Renal or liver impairment
    • Heart failure NYHA ≥ 3, EF < 50%, long QT syndrome
    • DVT or PE past 12 months
    • Anti-androgen therapy past 3 months
  • Primary Investigator(s):  Dr. Anuj Malik
  • Clinical Research Coordinator:  Jane Bryce, PhD, RN, AOCNS
  • Clinical Research Associate:
  • Regulatory Specialist: Sherri Coggin

LRT2: Tulsa

  • Purpose:
    • Evaluate optimal anticoagulation/antiplatelet regimen in low risk patients undergoing TAVR 
  • Two randomization arms post TAVR procedure:
    • Antiplatelet alone:  low dose ASA daily for 30-45 days 
    • Antiplatelet plus OAC:  low dose ASA and warfarin daily for 30-45 days 
  • Major Inclusion Criteria:
    • Patient undergoing low risk TAVR procedure
  • Major Exclusion Criteria:
    • HASBLED > 3
  • Primary Investigator(s):  Dr. Nicholas Hanna
  • Sub Investigator(s):  Dr. Thomas Kalapura; Rachel Mathew
  • Regulatory Specialist: Sherri Coggin

LRT: Tulsa

  • Purpose:
    • Assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bio prostheses in elderly patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).
  • Design:
    • Multicenter, prospective trial of TAVR in low-risk patients at up to twelve sites in the United States.
  • Major Inclusion Criteria:
    • Patient undergoing low risk TAVR procedure
  • Major Exclusion Criteria:
    • HASBLED > 3
  • Primary Investigator(s):  Dr. Nicholas Hanna
  • Sub Investigator(s): Dr. Thomas Kalapura; Rachel Mathew
  • Regulatory Specialist: Sherri Coggin

 

METEORIC: Tulsa

  • Purpose:
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  • Study Design:
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  • Major Inclusion Criteria:
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  • Major Exclusion Criteria:
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  • Primary Investigator(s): 
  • Sub Investigator(s): 
  • Clinical Research Coordinator: Mary Harris, MSN, RN
  • Regulatory Specialist: Sherri Coggin

METEORIC: Tulsa

Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells

                Purpose:

  • To assess the safety and tolerability of COVI-MSC vs. placebo in hospitalized subjects with COVID-19-induced ARD/ARDS
  • To assess the preliminary efficacy of COVI-MSC vs. placebo in hospitalized subjects with COVID-19-induced acute respiratory distress or acute respiratory distress syndrome (ARD/ARDS)
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  • Study Design:
  • Phase 2, double-blind, randomized
  • COVID-19 SOC vs COVID-19 standard of care plus COVI-MSC
  • Major Inclusion Criteria:
    • COVID-19 positive with symptoms suggestive of “severe” COVID
    • Hospitalized with COVID-29 induced acute respiratory distress
  • Major Exclusion Criteria:
    • Standard of Care appears to be working, patient is improving
    • Severe ARDS as determined by PI
    • CPR in last 14 days
    • Uncontrolled arrhythmias
    • MI in last 6 weeks
    • ALT > 275 or eGFR< 40 ml/min
  • Primary Investigator(s):  Dr. Anuj Malik
  • Sub Investigator(s):  Dr. Caleb Severns; Kari McCracken, PharmD
  • Clinical Research Coordinator: Anna Bryan, BSN, RN
  • Regulatory Specialist: Julie Davenport

PARAGLIDE HF: Tulsa & Bartlesville

A Multicenter, randomized, double-blind, double-dummy, parallel group, active controlled study to evaluate the effects of sacubitril/valsartan (LCZ696) on changes in NT-pro-BNP, safety and tolerability in HFpEF patients withWHF event (HFpEFdecompensation) who have been stabilized and initiated at the time of or within 30 days post-decompensation.

  • Purpose:
    • The purpose of this study is to assess the effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEFdecompensation) who have been stabilized and initiated at the time of or within 30 days post decompensation
  • Design:
    • 1:1 randomization to treatment with Entrestovs Valsartan (double-blind, double-dummy).
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  • Major Inclusion Criteria:
    • Currently hospitalized or within 30 days of a HFpEFdecompensation (in hospital, ED, or  urgent clinic HF visit) requiring IV diuretics,  with AECHF, LVEF > 40% within past 3 months, and hemodynamically stabilized 
    • BNP ≥150 pg/ml  (No Afib) or  ≥300 (Afib)
    • No ACEi  for at least 36 hours
  • Major Exclusion Criteria:
    • Entresto (sacubitril/valsartan) use within past 60 days 
    • Clurrent confirmed COVID19 infection or past COVID19 infection with persistent symptom burden suspected due to COVID19.
  • Primary Investigator(s):  Dr. Ravi Kode (Tulsa); Dr. Anderson Mehrle (Bartlesville) 
  • Sub Investigator(s): Dr. Nicholas Hanna; Dr. Heather Cha; Ashley Trombley, APRN; Russell Dixon, PharmD (Tulsa); Mollie Bechtelheimer, APRN; Stephanie Burns, PharmD (Bartlesville)
  • Clinical Research Coordinator: Jane Bryce, PhD, RN, AOCNS (Tulsa); Mary Harris, MSN, RN (Bartlesville)
  • Regulatory Specialist: Julie Davenport

PEA FSD-201-03 (Inpatient) COVID-19 Moderate to Severe Patients: Tulsa

Drug/Device: (Ultramicronized PEA) + Standard of Care (SOC) Vs SOC in the Treatment of Hospitalized Patients With COVID-19

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIA Study of FSD201 (Ultramicronized PEA) + Standard of Care (SOC) Vs SOC in the Treatment of Hospitalized Patients With COVID-1

  • Purpose:

Contraindicated Medications: Alpha-blockers, combined alpha/beta blockers, antihistamines, or any drugs that will affect the levels of cytokines released due to immune stress, use of immunoglobulins, investigational drugs. 

  • Study Design:
  • Major Inclusion Criteria:
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  • Major Exclusion Criteria:
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  • Primary Investigator(s): Dr. Anuj Malik 
  • Sub Investigator(s):  
  • Clinical Research Coordinator: Jane Bryce, PhD, RN, AOCNS
  • Clinical Research Assistant: Joy Norwood, BS
  • Regulatory Specialist: Julie Davenport

PRE-VENT: Tulsa

A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study of Pacritinib Plus Standard of Care Versus Placebo and Standard of Care in Hospitalized Patients with Severe COVID-19 With or Without Cancer

  • Purpose:
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  • Study Design:
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  • Major Inclusion Criteria:
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  • Major Exclusion Criteria:
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  • Primary Investigator(s): Dr. Vishal Mundra
  • Sub Investigator(s): Dr. Anuj Malik; Dr. Nicholas Hanna; Kari McCracken, PharmD
  • Clinical Research Coordinator: Jane Bryce, PhD, RN, AOCNS
  • Regulatory Specialist: Julie Davenport

PUL-042-501: Tulsa

A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Infection Rate and progression to COVID-19 in Adults Exposed to SARS-CoV-2

  • Purpose:
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  • Study Design:
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  • Major Inclusion Criteria:
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  • Major Exclusion Criteria:
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  • Primary Investigator(s): Dr. Anuj Malik
  • Sub Investigator(s): Dr. Vishal Mundra; Kari McCracken, PharmD
  • Clinical Research Coordinator: Kathryn Mears, MS, RN
  • Regulatory Specialist: Sherri Coggin

PUL-042-502: Tulsa

A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of OVID-19 in Adults Positive for SARS-CoV-2 Infections

  • Purpose:
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  • Study Design:
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  • Major Inclusion Criteria:
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  • Major Exclusion Criteria:
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  • Primary Investigator(s): Dr. Anuj Malik
  • Sub Investigator(s): Dr. Vishal Mundra; Kari McCracken, PharmD
  • Clinical Research Coordinator: Kathryn Mears, MS, RN

Regulatory Specialist: Julie Davenport

PROLACTA CGD

Effects of an Exclusive Human Milk Diet on Enteral Feeding Outcomes of Neonates with Congenital Gastrointestinal Disorders

  • Purpose:
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  • Study Design:
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  • Major Inclusion Criteria:
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  • Major Exclusion Criteria:
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  • Primary Investigator(s): Dr. Craig Anderson
  • Sub Investigator(s): Dr. Joel Stenzel; Lindsey Green, DNP, APRN-CNS, RNC-NIC, CCNS
  • Clinical Research Coordinator:Joy Norwood
  • Regulatory Specialist: Sherri Coggin

 

Blaze 4 (PYAH): Tulsa

A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)

Purpose:  The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. 

Study Design:

  • Randomized, Double-blind, Placebo-Controlled, Phase 2 Study
  • Major Inclusion Criteria:
    • COVID-19 positive with 3 days of randomization
    • Outpatient
  • Major Exclusion Criteria:
    • Hospitalized for COVID-19
    • Concurrent infection
  • Primary Investigator(s):  Dr. Anuj Malik
  • Sub Investigator(s):  Dr. Vishal Mundra
  • Clinical Research Coordinator:   Melanie Arnold, BSN, RN
  • Regulatory Specialist: Sherri Coggin

 

PYAB): Tulsa

Purpose:  

Study Design:

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  • Major Inclusion Criteria:
  • Major Exclusion Criteria:
  • Primary Investigator(s):  Dr. Anuj Malik
  • Sub Investigator(s):  Dr. Vishal Mundra
  • Clinical Research Coordinator:   Melanie Arnold, BSN, RN
  • Regulatory Specialist: Sherri Coggin

VTE Prophylaxis: Tulsa

  • Purpose: 
  • To determine if earthly VTE prophylaxis initiation, defined by ≤48h after hospital admission, among patients with blunt solid organ injury managed nonoperatively reduces the rates of VTE (deep vein thrombosis [DVT] and pulmonary emboli [PE]).
  • Study Design:
    • American Association for the Surgery of Trauma (AAST) multi-center prospective observational study.
  • Major Inclusion Criteria:
    • > 15years
    • Sustained blunt liver, spleen or kidney injury or combination
    • Initially managed nonoperatively defined by a lack of exploratory laparotomy ≤ 4 hours of hospital arrival
  • Major Exclusion Criteria:
    • Transfer from outside hospital
    • Death in Emergency Department
    • Pregnant
    • Home antiplatelet or anticoagulant medication
    • pre-existing bleeding disorder
    • Cirrhosis
    • Surgical management of injury within 4 hours of arrival
  • Primary Investigator(s):  Dr. Michael Charles
  • Sub Investigator(s):  
  • Clinical Research Assistant: Katie Knoten
  • Regulatory Specialist: Julie Davenport

Resources

Actively Enrolling
Actively Not Enorolling
  • Major Inclusion Criteria:
    • Adult hospitalized COVID-19 patients without respiratory failure needing oxygen therapy.
    • Ordinal scale 5 or 6  on the 8-point scale.
    • High risk category for disease progression
  • Major Exclusion Criteria:
    • Renal or liver impairment
    • Multi-organ failure
    • MI within the past 1 month,  NYHA III or IV, , uncontrolled hypertension
    • Immunomodulatory treatment for COVID-19 within 14 days of enrollment unless SOC
  • Primary Investigator(s):  Dr. Anuj Malik
  • Sub Investigator(s):  Dr. Vishal Mundra
  • Clinical Research Coordinator:   Jane Bryce, PhD, RN, AOCNS
  • Clinical Research Associate: 
  • Regulatory Specialist: Julie Davenport