COVID-19 Research

Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection with Symptoms) in Adults Residing With a Person With COVID-19

Sponsor: Merck Sharp & Dohme Corp.

Brief Summary:

The primary objectives of this phase 3, multicenter, randomized, double-blind, placebo-controlled study are to determine the efficacy, and safety/tolerability, of molnupiravir (MK-4482) in adults who reside with a person infected with COVID-19. It is hypothesized that molnupiravir is superior to placebo in preventing laboratory-confirmed COVID-19 infection through Day 14 in participants (regardless of baseline viral test result) who do not have confirmed or suspected COVID-19 at time of screening and randomization.

For information on enrolling patients in a clinical trial, please contact the research coordinator or assistant coordinator:

Principal Investigator: (Study Doctor) Mohamed Fayed, M.D.
Research Coordinator: Ashley Gutierrez –
(559) 499-6678, ashley.gutierrez@ucsf.edu
Research Assistant Coordinator: Maria Hernandez
 (559) 499-6502, mariaelena.hernandez@ucsf.edu

Title:  A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults ACTIV5/BET 

Sponsor:  National Institute of Allergy and Infectious Diseases (NIAID)

B ARM: Lenzilumab is a drug that is under investigation as a treatment for COVID-19. It is a type of drug called a monoclonal antibody and it works by attaching to natural proteins in the body that can cause inflammation. It ultimately reduces inflammation inside the body. Because inflammation seems to be one of the most serious problems during COVID-19 illness, this drug may be helpful as a treatment. 

C ARM: Danicopan is a study drug that is under investigation as a potential treatment for COVID-19. It has been given to more than 266 people in completed studies, including healthy people and people with certain conditions that affect the liver, kidneys or blood. Danicopan targets the immune system, part of the body that fights infections.

For information on enrolling patients in a clinical trial, please contact the research coordinator or assistant coordinator:

Principal Investigator: (Study Doctor) Mohamed Fayed, MD
Study Coordinator: Sonia Garcia, CCRP, CPT1
(559)499-6637, Sonia.Garcia@ucsf.edu
Assistant Coordinator: Maria Hernandez
(559) 499-6502, mariaelena.hernandez@ucsf.edu

TITLE: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With COVID-19

SPONSOR: Edesa Biotech Inc.

Brief Summary

COVID-19 patients who develop severe disease often develop acute respiratory distress syndrome (ARDS) as a result of a dysregulated immune response. Targeting the initial step in the signaling pathways of dysregulated immune response is the best hope for controlling the exaggerated host response to SARS-CoV-2 infection. EB05 has demonstrated safety in two clinical studies (>120 patients) and was able to block LPS-induced (TLR4 agonist) IL-6 release in humans. Given this extensive body of evidence, EB05 could ameliorate ARDS due to COVID-19, significantly reducing ventilation rates and mortality.

For information on enrolling patients in a clinical trial, please contact the research coordinator or assistant coordinator:

Principal Investigator: (Study Doctor) Mohamed Fayed, MD
Research Coordinator: Ashley Gutierrez
(559) 499-6678, ashley.gutierrez@ucsf.edu
Research Assistant Coordinator: Maria Hernandez
(559) 499-6502, mariaelena.hernandez@ucsf.edu

Title: DISulfiram for COvid-19 (DISCO) Trial (DISCO)

Sponsor: University of California, San Francisco

Brief summary:

The use of disulfiram in the treatment of patients with COVID-19 is experimental. This study is being done to see if disulfiram may have a role in reducing the severity of COVID-19 disease. Patients who become very ill with COVID-19 have been shown to have high levels of inflammation, and it is thought that the excess inflammation is what leads to worsening disease and death in some patients. Recent data suggests that disulfiram may potentially reduce the severity of COVID-19 disease by (1) directly preventing the virus from making more copies of itself and (2) reducing the abnormal inflammation that may lead to more severe COVID-19 disease.

For information on enrolling patients in a clinical trial, please contact the research coordinator or assistant coordinator:

Principal Investigator: (Study Doctor) Mohamed Fayed, MD
Research Coordinator: Ashley Gutierrez
(559) 499-6678, ashley.gutierrez@ucsf.edu
Research Assistant Coordinator: Maria Hernandez
(559) 499-6502, mariaelena.hernandez@ucsf.edu

Title: ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

We are studying two treatments for COVID-19. We are asking you to join the study because you are in the hospital with COVID-19 and have significant trouble with your breathing.

First, we are studying an experimental medicine, aviptadil (also called VIP), supplied by NeuroRx. We are trying to find out if giving this experimental medicine can help sick people in the hospital with COVID-19 have fewer bad effects from the disease, and if it may possibly help them get better and go home faster. We are also trying to see if it is safe.

This experimental medicine is a man-made version of a naturally occurring hormone in the body. It may decrease COVID-19 virus levels, inflammation, and blood clotting, and help protect the lung against injury. We think this experimental medicine may possibly help patients with COVID-19, and we think it will be safe, but we are not sure and so we are doing this study.

Second, we are studying a drug called remdesivir (also called Veklury) supplied by Gilead. Remdesivir is approved in the United States for the treatment for COVID-19 in people who are in the hospital. We are trying to find out if remdesivir helps patients with your level of COVID-19 illness get better and go home faster. Remdesivir may decrease COVID-19 virus levels and lung injury. Currently we do not know if remdesivir will help people with your level of COVID-19 illness which is why we are doing this study.

For information on enrolling patients in a clinical trial, please contact the research coordinator:

Principal Investigator: (Study Doctor) Eyad Almasri, MD
Research Coordinator: Alyssa Hughes
(559) 499-6679, alyssa.hughes@ucsf.edu 

Title: ACTIV-3: Therapeutics for Inpatients With COVID-19 (TICO)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (University of Minnesota)

Brief Summary:

Understanding of the humoral immune response is evolving, with some evidence that responses are variable between individuals and delayed in some cases. It may therefore be that viral replication leads to extensive tissue damage and inflammatory responses in the lungs and other organs before the development of neutralizing antibodies. Augmentation of the humoral immune response to SARS-CoV-2 infection using passive immunotherapy to SARS-CoV-2 in hospitalized patients with moderate to severe COVID-19 may thus improve the disease course and reduce the time to recovery.

For information on enrolling patients in a clinical trial, please contact the research coordinator:

Principal Investigator: (Study Doctor) Eyad Almasri, MD
Research Coordinator: Alyssa Hughes
(559) 499-6679, alyssa.hughes@ucsf.edu 

Title: A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects

Sponsor:  Suzhou Kintor Pharmaceutical Inc,

Brief summary:

 COVID-19 emerged in late 2019 and spread rapidly, resulting in a global pandemic. SARS-CoV-2 encodes nonstructural and structural proteins required for its viral life cycle. Among them, the spike glycoprotein plays a pivotal role in SARS-CoV-2 infection by recognizing and attaching to ACE2 transmembrane protein on host cells. Kintor protocol has been designed to evaluate efficacy and safety of GT0918 in hospitalized subjects with COVID-19 illness. The target population of this study is hospitalized subjects with COVID-19 illness with positive SARS-CoV-2 virus test within 72 hours of randomization. The study will evaluate if anti-androgen therapy may effectively prevent progression to the more severe form of COVID-19 illness and death, shorten the time to sustained recovery and decrease the mortality rate. This study plans to have around 1,030 subjects in the United States and other countries/regions who will be randomized for GT0918 and the placebo groups; the randomization rate is 1:1. Subject will receive either GT0918 plus standard of care or matched placebo plus standard of care. GT0918/placebo will be given 300mg orally once a day around 30 minutes after meal for 14 days or until discharge per investigators’ discretion whichever occurs later; the safety follow up will be until Day 60 ± 3 days. The primary endpoint is time to sustained recovery by Day 30 and the key secondary endpoint is 30-day mortality.

For information on enrolling patients in a clinical trial, please contact the research coordinator:

Principal Investigator: (Study Doctor) Eyad Almasri, MD
Research Coordinator: Alyssa Hughes
(559) 499-6679, alyssa.hughes@ucsf.edu 

TITLE:  COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications (ACTIV6)

SPONSOR: Duke Clinical Research Institute,

Brief summary:                                        

Researchers would like to evaluate whether medications that are already approved by the FDA for other disease might also work for COVID-19.  This study is testing this in people with mild to moderate COVID-19 who do not require hospitalization. Use of these drugs for this study is considered “investigational.” Investigational means these study medications or placebo are being researched for their effect on COVID-19. They are not approved by the FDA as treatment for COVID-19, but they are approved by the FDA for some other conditions.

For information on enrolling patients in a clinical trial, please contact the research coordinator or assistant coordinator:

Principal Investigator: (Study Doctor) Mohamed Fayed, MD
Research Coordinator: Sonia Garcia, CCRP, CPT1
(559) 499-6637, Sonia.Garcia@ucsf.edu
Assistant Coordinator: Maria Hernandez
(559) 499-6502, mariaelena.hernandez@ucsf.edu

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/