Large Clinical Trial of Hydroxychloroquine for COVID-19 Sponsored by Novartis After Reaching Agreement With FDA

Switzerland-based pharmaceutical firm Novartis says it will be conducting a clinical trial of antimalarial drug hydroxychloroquine on U.S. hospital patients with COVID-19.

The company confirmed today an agreement had been struck with the Food and Drug Administration (FDA) to proceed with a trial on more than 400 infected patients—hoping to evaluate the effectiveness of the drug once described as a potential "game-changer" by President Donald Trump.

There is no cure for the infectious respiratory disease, caused by a novel coronavirus that was first detected in China last year, according to the Centers for Disease Control and Prevention.

But in recent weeks, clinical tests have been taking place around the world in an attempt to determine if hydroxychloroquine could ease some of its symptoms—with largely mixed results.

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In White House briefings and on Twitter, the president has promoted the drug as a potential treatment and earlier confirmed the U.S. had stockpiled 29 million pills, despite its use being unproven.

Novartis has said its upcoming clinical trial will take place at "more than a dozen sites" in the country and plans to begin enrollment for the study within the next few weeks. The trial's drug supply will be provided by Sandoz, the generics and biosimilars arm of the company.

The patients in the trial will be randomized into three groups, with the first group administered with hydroxychloroquine. The second group will receive hydroxychloroquine in combination with azithromycin, an antibiotic therapy. The third patient group will receive placebo medicine.

Those in the trial will continue to receive standard COVID-19 hospital treatment. Novartis said months of work had been compressed into weeks, and noted any intellectual property proven to work will be made available via non-exclusive voluntary licenses and "appropriate waivers."

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"We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease," said John Tsai, Novartis' chief medical officer.
"We mobilized quickly to address this question in a randomized... placebo-controlled study."

In addition to hydroxychloroquine, Novartis said it plans to sponsor or co-sponsor clinical trials to study ruxolitinib and canakinumab for hospitalized patients who have contracted COVID-19.

On April 3, the FDA authorized the emergency use of hydroxychloroquine from the Strategic National Stockpile to treat patients hospitalized with the illness. But it warned of a wide range of potential side effects and stressed that the optimal dosing and duration of treatment remained unknown.

As previously reported, an experimental hydroxychloroquine treatment on at least one COVID-19 patient in France had to be stopped as it was found to be a "major risk" to cardiac health. The Los Angeles Times reported trials in China and Brazil failed to help patients recover from the disease.

CNBC reported studies into the effectiveness of hydroxychloroquine are ongoing at the University of Washington and University of Minnesota. There are no definitive results at present.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and a member of the White House Coronavirus Task Force, has repeatedly urged caution over the drug's use. Trump, meanwhile, has taken a decidedly more flexible approach when discussing its possible merits. "What do you have to lose?" the president remarked during an April 6 media briefing.

Centers for Disease Control and Prevention Advice on Using Face Coverings to Slow Spread of COVID-19

  • CDC recommends wearing a cloth face covering in public where social distancing measures are difficult to maintain.
  • A simple cloth face covering can help slow the spread of the virus by those infected and by those who do not exhibit symptoms.
  • Cloth face coverings can be fashioned from household items. Guides are offered by the CDC. (https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/diy-cloth-face-coverings.html)
  • Cloth face coverings should be washed regularly. A washing machine will suffice.
  • Practice safe removal of face coverings by not touching eyes, nose, and mouth, and wash hands immediately after removing the covering.

World Health Organization advice for avoiding spread of coronavirus disease (COVID-19)

Hygiene advice

  • Clean hands frequently with soap and water, or alcohol-based hand rub.
  • Wash hands after coughing or sneezing; when caring for the sick; before, during and after food preparation; before eating; after using the toilet; when hands are visibly dirty; and after handling animals or waste.
  • Maintain at least 1 meter (3 feet) distance from anyone who is coughing or sneezing.
  • Avoid touching your hands, nose and mouth. Do not spit in public.
  • Cover your mouth and nose with a tissue or bent elbow when coughing or sneezing. Discard the tissue immediately and clean your hands.

Medical advice

  • Avoid close contact with others if you have any symptoms.
  • Stay at home if you feel unwell, even with mild symptoms such as headache and runny nose, to avoid potential spread of the disease to medical facilities and other people.
  • If you develop serious symptoms (fever, cough, difficulty breathing) seek medical care early and contact local health authorities in advance.
  • Note any recent contact with others and travel details to provide to authorities who can trace and prevent spread of the disease.
  • Stay up to date on COVID-19 developments issued by health authorities and follow their guidance.

Mask and glove usage

  • Healthy individuals only need to wear a mask if taking care of a sick person.
  • Wear a mask if you are coughing or sneezing.
  • Masks are effective when used in combination with frequent hand cleaning.
  • Do not touch the mask while wearing it. Clean hands if you touch the mask.
  • Learn how to properly put on, remove and dispose of masks. Clean hands after disposing of the mask.
  • Do not reuse single-use masks.
  • Regularly washing bare hands is more effective against catching COVID-19 than wearing rubber gloves.
  • The COVID-19 virus can still be picked up on rubber gloves and transmitted by touching your face.
Hydroxychloroquine
In this photo illustration a pack of Hydroxychloroquine Sulfate medication is displayed on March 26, 2020 in London, United Kingdom. John Phillips/Getty
Large Clinical Trial of Hydroxychloroquine for COVID-19 Sponsored by Novartis After Reaching Agreement With FDA | Tech & Science