Title: Adaptive COVID-19 Treatment Trial 4 (ACTT-4)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Brief summary:
ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.
Principal Investigator: (Study Doctor) Eyad Almasri, MD
Publication link: not available yet
Title: A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19
Sponsor: Sage Therapeutics
Brief summary:
Brexanolone is an FDA-approved intravenous (IV) infusion for the treatment of postpartum depression (PPD) in adults. Brexanolone has the potential to attenuate the impact of COVID-19 in ventilated patients through multiple mechanisms of action. Pre-clinical evidence to date suggests that brexanolone is likely to have the following beneficial effects in the clinic: anti-inflammatory and fluid clearance effects via direct action on GABAA receptors located in human alveolar epithelial cells; anti-inflammatory and antiviral effects via inhibition of toll-like receptors and reduction in proinflammatory cytokines; and direct effects on pulmonary function through direct effects on smooth muscle in the lung, reducing shunting and improving partial pressure of arterial oxygen (PaO2).
Principal Investigator: (Study Doctor) Mohamed Fayed, MD
Publication link: not available yet
Title: A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
Sponsor: Apellis Pharmaceuticals, Inc
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of APL-9 in adults with mild to moderate ARDS (acute respiratory distress syndrome) caused by COVID-19 who are hospitalized and require supplemental oxygen therapy with or without mechanical ventilation.
It is thought that COVID-19 activates the complement system, part of the immune system that responds to infection or tissue damage and increases inflammation in the lungs. APL-9 has been designed to inhibit or block activation of part of the complement pathway, and potentially reduce inflammation in the lungs.
Part 1 of the study is open-label to evaluate safety; all participants will receive APL-9 plus standard of care. Part 2 of the study is double-blind, randomized; participants will receive either APL-9 or the vehicle-control plus standard of care.
Principal Investigator: (Study Doctor) Eyad Almasri, MD
Publication link: not available yet
Title: Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19 (CoronaStem1)
Sponsor: Sorrento Therapeutics, Inc.
Brief summary:
This study is single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of PSC-04, an adipose-derived allogeneic mesenchymal stem cell. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients. The primary study objectives are to evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 disease and respiratory distress. The secondary study objectives are to evaluate a set of secondary safety and efficacy outcome variables to give guidance in assessing the risk/benefit ratio in patients with COVID-19 respiratory distress.
Principal Investigator: (Study Doctor) Eyad Almasri, MD
Publication link: not available yet
Title: Outcomes Related to COVID-19 Treated with Hydroxychloroquine Among In-patients with Symptomatic Disease (ORCHID)
Sponsor: Massachusetts General Hospital
Brief summary:
ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Effective therapies for COVID-19 are urgently needed. Hydroxychloroquine is an antimicrobial agent with immunomodulatory and antiviral properties that has demonstrated in vitro activity against SARS-CoV-2, the virus that causes COVID-19. Preliminary reports suggest potential efficacy in small human studies. Clinical trial data are needed to determine whether hydroxychloroquine is effective in treating COVID-19.
Principal Investigator: (Study Doctor) Eyad Almasri, MD
Publication link: https://jamanetwork.com/journals/jama/fullarticle/2772922
Title: Effectiveness of mRNA Covid-19 Vaccine among U.S. Health Care Personnel
Brief summary:
The prioritization of U.S. health care personnel for early receipt of messenger RNA (mRNA) vaccines against severe acute respiratory disease coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (Covid-19), allowed for the evaluation of the effectiveness of these new vaccines in a real-world setting.
Principle investigator at UCSF Fresno: Brian Chinnock, MD
Publication link: https://www.nejm.org/doi/10.1056/NEJMoa2106599?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
Title: The Rapid Evaluation of COVID-19 Vaccination in Emergency Departments for Underserved Patients Study
Brief summary:
Emergency departments (EDs) often serve vulnerable populations who may lack primary care and have suffered disproportionate COVID-19 pandemic effects. Comparing patients having and lacking a regular source of medical care and other ED patient characteristics, we assessed COVID-19 vaccine hesitancy, reasons for not wanting the vaccine, perceived access to vaccine sites, and willingness to get the vaccine as part of ED care.
Publication link: https://pubmed.ncbi.nlm.nih.gov/34272104/
Title: Interim Estimates of Vaccine Effectiveness of Pfizer-BioNTech and Moderna COVID-19 Vaccines Among Health Care Personnel – 33 U.S. Sites, January-March 2021
Publication link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8136422/
Title: Emergency physician stressors, concerns, and behavioral changes during COVID-19: A longitudinal study
Publication link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014663/
Title: Academic Emergency Medicine Physicians’ Anxiety Levels, Stressors, and Potential Stress Mitigation Measures During the Acceleration Phase of the COVID-19 Pandemic
Publication link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7361565/
