Therapeutic Protocols for Hospitalized Patients


Study & PI
A Randomized Placebo-Controlled Safety and Dose-Finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients with Life-Threatening COVID-19 Infection

PI: Nada Alachkar
This investigator initiated study will administer clazakizumab, a humanized IgG1 monoclonal antibody that binds to human IL-6, to COVID-19 patients in respiratory failure due to hyperinflammation resulting from a cytokine storm. Objectives include assessing efficacy by evaluating the incidence and duration of mechanical ventilation, the length of ICU stay and patient survival.
Alpha-1 Adrenergic Receptor Antagonism to Prevent COVID-19 Cytokine Storm Syndrome and Acute Respiratory Distress Syndrome: A Randomized Study Comparing the Efficacy of Prazosin vs. Standard of Care for SARS-CoV-2 infection

PI: Chetan Bettegowda
This randomized trial will assess the safety and efficacy of prazosin to treat COVID-19 in adults 45 years of age or older. Eligible subjects have symptomatic COVID-19 and are hospitalized. Treatment with prazosin, by reducing catecholamine surges and secondary cytokine dysregulation, is hypothesized to potentially reduce the severity of COVID-19.
ARrest RESpiraTory Failure in Pneumonia (ARREST Pneumonia)

PI: Williams Checkley
The primary objective of this multi-center, double-blind, placebo controlled clinical trial is to establish the efficacy of early treatment with an inhaled corticosteroid (Budesonide) combined with a beta-agonist (Formoterol) vs. usual care for the prevention of acute respiratory failure in adults hospitalized with severe pneumonia, with confirmed or high-clinical suspicion for COVID-19 infection, and hypoxemia, who are not intubated prior to enrollment.
A Multi-center, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

PI: Noreen Hynes
The current protocol will evaluate the combination of the Janus Kinase inhibitor baricitinib and the anti-viral drug remdesivir compared to remdesivir alone for the treatment of hospitalized subjects with COVID-19. This change was made following a preliminary review of data from the first stage of this study, ACTT-1, which showed better clinical outcomes for subjects who received remdesivir compared to placebo.
Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected with SARS-CoV-2

PI: Sanjay Jain
Hospitalized and non-hospitalized children (1 month – <18 years) who are at high risk for disease progression and either have confirmed SARS-CoV-2 infection or a high-risk exposure are eligible for a single infusion of Human Coronavirus Immune Plasma.
A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS 181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

PI: Shmuel Shoham
A sub-study to this ongoing protocol has been added that will investigate the potential clinical utility of DAS181, a viral receptor inactivator, in reducing viral burden and providing meaningful clinical benefit to patients infected with SARSCoV-2. It will primarily target COVID-19 patients who exhibit clinically significant impairment of respiratory function and may or may not be immunocompromised. This study is designed as a two stage randomized (1:1), placebo-controlled, double-blind trial.
COVID-19 Anticoagulation in Children – Thromboprophylaxis (COVAC-TP) Trial

PI: Anthony Sochet
This single-arm, open-label, non-randomized clinical trial evaluates the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as in-hospital venous thromboembolism (VTE) prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of COVID-19.
A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Mechanically Ventilated Intubated Patients with Respiratory Failure due to COVID-19

PI: David Hager
Recent observations suggest that passively administered antibodies from convalescent plasma has the potential to provide benefit against coronavirus infections. In this study, mechanically ventilated patients with respiratory failure due to COVID-19 will be administered multiple doses of convalescent plasma primarily to determine safety and feasibility, as well as secondarily to assess efficacy. All donors of convalescent plasma must meet the FDA’s current qualifications.
Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment

PI: Dale Needham

This ongoing study was recently amended to include COVID-19 patients. A within-patient, crossover, randomized controlled trial design is being used to evaluate a novel arm restraint device in adults age 50 and older who will require at least 2 days of treatment in the ICU to see if the device has beneficial effects such as reducing immobility, requirement for sedation and agitation. Patients, their family members and the clinical staff caring for these individuals will also be asked to provide feedback about their satisfaction with and acceptability/ perceptions of the device. This study was recently amended to include an a priori subgroup analysis comparing outcomes in non-COVID-19 versus COVID-19 patients.
Prone Position and Respiratory Outcomes in Non-Intubated COVID Patients: The “PRONE” Study

PI: Naresh Punjabi
This is a randomized trial of prone vs. usual care positioning to determine if the improvements in oxygenation observed following prone positioning in mechanically ventilated patients with moderate-to-severe ARDS (induced by COVID-19 or otherwise) can also be achieved in spontaneously breathing, non-intubated, hospitalized COVID-19 patients.
The Safety of EIDD-2801 and Its Effect on Viral Shedding of SARS-CoV-2

PI: Ashwin Balagopal

This is a randomized, placebo-controlled, double-blinded clinical trial of the antiviral drug EIDD-2801 in hospitalized adults who present within seven days of symptom onset and within 48 hours of testing positive for SARS-CoV-2. EIDD-2801 is an orally bioavailable prodrug of a nucleotide analog designed to inhibit viral replication, which has shown antiviral activity in animal models of SARS-CoV- 1 and MERS.
CRITICAL: CRIzanlizumab for Treating COVID-19 vAscuLopathy

PI: Charles Lowenstein
This randomized, double-blind, placebo-controlled trial aims to determine the therapeutic effect and tolerance of crizanlizumab in hospitalized patients with moderate stage coronavirus disease 2019 (COVID19). Crizanlizumab blocks P-selectin released by activated endothelial cells, thereby preventing leukocytes and platelets from adhering to the vessel wall, and limiting blockage and inflammation of small blood vessels. Outcomes will focus on biomarkers that indicate progression of disease.
A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19

PI: Ephraim Fuchs

This randomized trial tests whether adding acalabrutinib to best supportive care (BSC; allows steroids or remdesivir) is safe and improves the outcome of hospitalized patients diagnosed with COVID-19. Hypoxemic but not critically ill inpatients will be randomized in a 1:1 ratio to receive acalabrutinib 100 mg po twice daily for 10 days plus BSC versus BSC alone. Acalabrutinib, a Bruton’s tyrosine kinase inhibitor, is hypothesized to work by binding to and inhibiting the NLRP3 inflammasome, a proximal mediator of the cytokine storm in COVID-19.
Upward Incline Positioning in Hypoxemic COVID-19 Patients Prevents Development of Acute Respiratory Failure

PI: Luu Pham
coming soon
A Phase II Trial to Promote Recovery from COVID-19 with Endocrine Therapy

PI: Catherine Marshall
coming soon
Decitabine for COVID-19 Pneumonia-ARDS Treatment: DART Trial

PI: Franco D'Alessio
coming soon
A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome

PI: Robert Brodsky
This study will explore whether or not ravulizumab, which inhibits complement component 5-mediated terminal complement activity, can help control the inflammatory processes which drive COVID-19 related acute respiratory distress syndrome (ARDS). Inpatient adults randomized to ravulizumab will receive 4 doses of this drug over two weeks (days 1, 5, 10 and 15).
A Phase 1 Double Blinded Randomized Placebo Safety and Early Efficacy Trial of Cord Blood Derived T-Regulatory Cell Infusions in the Treatment of COVID-19 Induced Acute Respiratory Distress Syndrome

PI: Douglas Gladstone
This study tests the hypothesis that infusing healthy, allogeneic T-regulatory (T-reg) cells to restore the normal inflammatory balance disrupted by COVID -19 may help resolve inflammation and improve the clinical outcomes in intubated patients suffering from moderate to severe acute respiratory distress syndrome (ARDS) secondary to COVID-19 infection. Cord Blood derived T-reg cells are given intravenously on days 0, 3, and 7, at one of two different doses versus placebo. Pre-existing medications are allowed as per the PI, as is some steroid use though high dose steroids (greater than 1mg/kg daily) are contraindicated.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants with COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)

PI: David Hager
Ruxolitinib is a potent and selective inhibitor of JAK1 and JAK2. Participants will be randomized 2:2:1, ruxolitinib 5 mg BID: ruxolitinib 15 mg BID: placebo (placebo randomized 1:1 to match ruxolitinib 5 mg or 15 mg), to assess the efficacy and safety of 2 doses of ruxolitinib (5 mg and 15 mg BID) plus standard of care (SoC) therapy, compared with placebo plus SoC therapy. Subjects will be treated for 14 days with a possible extension to 28 days.
An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, and Safety and Tolerability of Acalabrutinib Suspension Delivered via Nasogastric Tube, Coadministered With a Proton-pump Inhibitor, in Participants Hospitalized With COVID-19

PI: Brent Petty
This study is supporting the ongoing clinical trial of the BTK inhibitor acalabrutinib in hospitalized COVID-19 patients. In this study, patients will be enrolled who are unable to swallow capsules and are also receiving Proton-pump inhibitors. In addition to receiving best supportive care, participants will be treated with an acalabrutinib suspension (delivered via NG tube) for 14 days or a maximum of 28 doses to determine safety and tolerability, as well as pharmacokinetics of acalabrutinib.
IMPAACT 2032 - Pharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the United States

PI: Sharon Nachman
coming soon
A Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OP-101 (dendrimer n-acetyl-cysteine) in Patients with Severe COVID-19

PI: Nauder Faraday
coming soon