Current Approved Therapeutic Protocols for COVID-19

 

Last updated May 27, 2020

 

 

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.

 

An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumb for Hospitalized Patients with COVID-19 | PI: Daniel Brotman

This study will explore whether or not sarilumab, which blocks the IL-6R, can modify the progression of COVID-19 disease by temporarily attenuating the localized pulmonary “cytokine storm”. Eligible subjects will have evidence of pneumonia & meet the criteria for critical disease. Participants will be randomized in a 2:1 ratio to sarilumab 400 mg IV or placebo.

 

A Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Hydroxychloroquine Monotherapy and in Combination with Azithromycin in Patients with Moderate and Severe COVID- 19 Disease | PI: Richard Chaisson

The primary objective of this study is to test the efficacy of a 10 day course of  hydroxychloroquine with or without a 5 day course of azithromycin in achieving a clinical response by day 15 in hospitalized adults with COVID-19 who are not critically ill (i.e. those who do not require ICU admission or mechanical ventilation).

 

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.

 

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.

 

Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs Control (SARS-CoV-2 Non- Immune Plasma) among Adults Exposed to COVID-19 | PI: Shmuel Shoham

This study will assess the efficacy and safety of Human Coronavirus Immune Plasma (HCIP) as prophylaxis in adults following recent, close contact exposure to COVID-19  who have not yet themselves developed symptoms of infection, and are at a high risk for severe illness. Eligible subjects, which can include health care personnel with high risk exposure, will be randomized in a 1:1 ratio to receive either HCIP or control plasma.

 

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.

 

Convalescent Plasma to Limit Coronavirus Associated Complications: A Randomized, Double-Blind, Controlled, Phase 2 Study Comparing the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 non-immune) Plasma Among Outpatients with Symptomatic COVID-19 | PI: David Sullivan

This study will assess the efficacy and safety of Human Coronavirus Immune Plasma (HCIP) to reduce the risk of hospitalization or death in adults who are positive by RNA detection for SARS-CoV-2 and have at least one symptom of COVID-19. In addition, the impact of HCIP on the duration of symptoms and nasopharyngeal or oropharyngeal viral shedding will be assessed. Eligible subjects will be stratified 50:50 in the <65 vs > 65 age range and will be randomized in a 1:1 ratio to receive either HCIP or control plasma.

 

Expanded Access

Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19 | Christian Merlo

This umbrella expanded access protocol provides access to investigational convalescent plasma for patients with a laboratory confirmed diagnosis of SARS-CoV-2 infection who have or are at high risk for progression to severe or life-threatening disease. Safety information will be collected, as will patient demographics and data associated with the utilization of acute care facility resources.

 

Compassionate Use of Remdesivir for the Treatment of SARS-CoV-2 COVID-19 | PI: David Berman

When approved by the FDA in individual single patient compassionate use applications, this umbrella protocol can provide pediatric patients with access to remdesivir for the treatment of COVID-19.