An Open Data Clinical Trial for COVID-19 Prevention
Clinical trial by Gautret, Raoult, et al. (2020)What is this initiative?
We're an independent group of scientists and physicians working on an open-data clinical trial for prevention of COVID-19, through the use of hydroxychloroquine in combination with other therapeutic agents.
Unlike a typical commercial drug trial, our objective is to share trial data with the public* and health-care professionals as close to real-time as possible (with a reasonable level of data quality assurance).
Given the rapidly spreading coronavirus pandemic, we're looking for every possible means to fast-track the effort.
* Data will be de-identified to preserve participants' privacy and conform with regulatory requirements.
How can I participate in the trial?
Objective: Evaluate the efficacy of hydroxychloroquine in the prevention of COVID-19 infection.
Current Phase: We're first focusing on a cohort study of healthy medical professionals.
Status: Active / Recruiting
Join the study: If you're a front-line healthcare worker (physician, nurse, etc.), and willing to participate in the trial (or already taking hydroxychloroquine), please send us an email.
Future phase: Case-control study of hydroxychloroquine in the prevention of COVID-19. Stay tuned.
Can my company / organization participate in the trial?
Could I support the project in other ways?
If you're interested to support or partner on regulatory front, clinical trial, or funding, please send us an email.
Background
A recent well controlled clinical study conducted by Didier Raoult M.D/Ph.D, et. al in France has shown that 100% of patients that received a combination of HCQ and Azithromycin tested negative and were virologically cured within 6 days of treatment.
In addition, recent guidelines from South Korea and China report that hydroxychloroquine and chloroquine are effective antiviral therapeutic treatments for novel coronavirus.
A therapeutic agent that prevents infection with novel coronavirus is highly desirable--especially for persons with high-risk exposure (e.g healthcare professionals) as well as persons with comorbidities (heart disease, diabetes, etc) and compromised immune systems. Ground-breaking in vitro studies demonstrate potential efficacy of hydroxychloroquine as a prophylactic for novel coronavirus infection in primate cells.
Note: Hydroxychloroquine (brand name Plaquenil) is an inexpensive, globally available drug (tablet) that was approved for widespread medical use since 1955. It is commonly used today to treat malaria, systemic lupus erythematosus and rheumatoid arthritis.
Project Lead
Gregory J. Rigano, Esq
Mr. Rigano is an Advisor to the Stanford University School of Medicine SPARK Translational Research Program. He's led a biotech firm for the past five years in research and clinical evaluation of Chloroquine in various diseases.
Gregory has provided counsel to over $1 billion in transaction volume at global scale with a strong focus on the sciences involving multi-national corporations and the federal government. Gregory’s experience includes advancing various pharmaceutical assets through laboratory, animal, formulation, manufacturing, clinical trials (Phase I - III) as well as commercialization. Mr. Rigano received his Juris Doctor degree from Hofstra University, and studied at Johns Hopkins University.
Consulting Scientists & Physicians
Didier Raoult, MD & Ph.D
Didier Raoult created the Rickettsia Unit at Aix-Marseille University. Since 2008, Dr. Raoult has served as the director of URMITE (Research Unit in Infectious and Tropical Emergent Diseases), collaborating with CNRS (National Center for the Scientific Research), IRD (Research for the Development Institute), INSERM (National Institute of Health and Medical Research) and Aix Marseille University. His laboratory employs more than 200 people, including nearly 100 active researchers who publish between 250 and 350 papers per year and have produced over 50 patents.