Dr. Fauci and the Data on Hydroxychloroquine - COVID-19 Clinical Trial
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Dr. Fauci and the Data on Hydroxychloroquine

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    In recent weeks, hydroxychloroquine has become one of the biggest buzzwords amid the coronavirus outbreak. Initial research suggests that hydroxychloroquine may show promise as a COVID-19 treatment, causing reporters, patients, and social media users alike to jump to conclusions. 

    When misinformation on such an essential topic can spread so quickly, it’s important to focus on the facts established through science and data. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Disease, is leading the way in this critical research, including the dozens of clinical trials currently underway.  

    As he emphasized in an April 1 White House briefing, “The definitive way that you get an answer is by doing a randomized, controlled, clinical trial.” 

    The Most Important Hydroxychloroquine Clinical Trials 

    Of the 388 clinical trials related to COVID-19 currently listed with the FDA, 55 are studying hydroxychloroquine in the prevention or treatment of coronavirus infections. Many are still in preliminary planning stages: 

    • Hydroxychloroquine vs Azithromycin for Hospitalized Patients with Suspected or Confirmed COVID-19 taking place in Utah 
    • Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease taking place at Columbia University Irving Medical Center in New York, NY 
    • Effectiveness of Hydroxychloroquine in COVID-19 Patients taking place at Ayub Teaching Institution in Pakistan 

    Other clinical trials are actively enrolling participants in order to initiate research as soon as possible: 

    • Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers taking place at Baylor University Medical Center in Dallas, Texas 
    • Hydroxychloroquine in Patients with Newly Diagnosed COVID-19 Compared to Standard of Care taking place at Portland Providence Medical Center in Portland, Oregon 
    • Hydroxychloroquine Versus Placebo in COVID-19 Patients at Risk for Severe Disease taking place at multiple locations throughout France 

    Most notably, the World Health Organization recently added hydroxychloroquine to its international Solidarity trial designed to compare multiple COVID-19 treatment options and assess their relative effectiveness against the virus. According to the WHO, “the Solidarity trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Other drugs can be added based on emerging evidence.” 

    The University of Pennsylvania also launched a “Prevention and Treatment of COVID-19 with HCQ (PATCH)” study to test whether hydroxychloroquine can help treat or prevent coronavirus. Eligible clinical trial volunteers must have a fever, be over 40, and have recently been sick with the virus. 

    Success Rates in Healthy and Sick Patients 

    At this time, only two hydroxychloroquine clinical trials have been completed, so the research data available is minimal.  

    The first completed clinical trial took place in Marseilles, France. Of the 36 people studied by physician-scientist Didier Raoult and his team, 16 were infected controls and 20 were treated patients.  

    All 20 test patients received 600 mg daily of Plaquenil. By Day 3, half of the treated patients tested negative for the COVID-19 virus. By Day 6, a full 70% tested negative.  

    This clinical trial also used six patients to measure the effects of treating the coronavirus with a combination of Plaquenil and the antibiotic azithromycin. Of these six patients, five of them tested negative for COVID-19 on Day 3 and all six of them tested negative by Day 6.  

    These results were dramatically different than the infected control patients. Only 6.3% and 12.5% tested negative for COVID-19 on Day 3 and Day 6, respectively. In response to the findings of this clinical trial, the French Minister of Health approved new expanded treatment trials.  

    The Shanghai Public Health Clinical Center also sponsored a clinical trial in February 2020 to evaluate the efficacy and safety of hydroxychloroquine in the treatment of pneumonia caused by COVID-19. This randomized clinical trial studied 30 participants. Half of the participants received hydroxychloroquine treatment for five days plus conventional treatment, while the other half received conventional treatment only.  

    After seven days, 13 patients treated with hydroxychloroquine tested negative for COVID-19, as did 14 patients in the control group. As the study notes, “Larger sample size studies are needed to investigate the effects of hydroxychloroquine in the treatment of COVID-19.” 

    Overall Conclusions From the Data 

    According to the FDA, “Based upon limited in-vitro and anecdotal clinical data in case series, [hydroxychloroquine is] currently recommended for treatment of hospitalized COVID-19 patients in several countries, and a number of national guidelines report incorporating recommendations regarding its use.”  

    However, with only two small clinical trials completed, the data is not yet clear, and permanent recommendations cannot be made on in-vitro and anecdotal evidence alone. The FDA plans to update its advice as more clinical trials conclude.  

    Denise Hinton, Chief Scientist of the FDA, explained, “Clinical trial data results, and any information derived from clinical trials, as well as clinical trial results from studies of other investigational medical products to treat COVID-19, will continue to inform [the FDA’s] risk benefit assessment.” 

    Are Hospitals Currently Treating Patients with Hydroxychloroquine? 

    As the medical community awaits clinical trial results, the FDA has granted hydroxychloroquine compassionate use status in treating coronavirus. This means that COVID-19 patients with serious or life-threatening cases of the virus now have access to a potentially life-saving treatment, and many hospitals have stockpiled hydroxychloroquine to ensure rapid treatment.  

    The FDA also approved the use of hydroxychloroquine from the Strategic National Stockpile (SNS) for treatment of COVID-19. Under the rules of this Emergency Use Authorization (EUA), all hydroxychloroquine “must be administered by a healthcare provider pursuant to a valid prescription of a licensed practitioner,” and, “may only be used to treat adult and adolescent patients who weigh 50 kg or more hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible.” 

    As a result, hospitals in New York, Louisiana, and other hard-hit areas are treating high-risk COVID-19 patients with hydroxychloroquine and eagerly awaiting the results of pending clinical trials.  

    Sources

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