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, [email protected]
Research Assistant Coordinator: Maria Hernandez
(559) 499-6502, [email protected]
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, [email protected]
Assistant Coordinator: Maria Hernandez
(559) 499-6502, [email protected]
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, [email protected]
Research Assistant Coordinator: Maria Hernandez
(559) 499-6502, [email protected]
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, [email protected]
Research Assistant Coordinator: Maria Hernandez
(559) 499-6502, [email protected]
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, [email protected]
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, [email protected]