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NIH begins clinical trial of hydroxychloroquine and azithromycin to treat coronavirus patients

NIH doses first coronavirus patient in trial of hydroxychloroquine and antibiotic combo touted by Trump in hopes the controversial drug will cut risks of hospitalization and death

  • The NIH has begun a clinical trial testing anti-malaria drug hydroxychloroquine and antibiotic azithromycin in coronavirus patients
  • Patients will either be assigned the experimental treatment or a pair of placebos to take over the course of week
  • Researchers want to see if the combination of drugs can prevent hospitalization and death from COVID-19
  • President Donald Trump has touted hydroxychloroquine in the past as a ‘game-changer’ in treating coronavirus  
  • Here’s how to help people impacted by Covid-19

The National Institutes of Health (NIH) announced it has begun a clinical trial testing a combination of the anti-malaria drug hydroxychloroquine and the antibiotic azithromycin in coronavirus patients.

Investigators will enroll approximately 2,000 adults across the US who all must have a confirmed case the virus and classic symptoms such as fever, coughing and shortness of breath.

The study will assess whether the combination of drugs can prevent hospitalization and death from COVID-19, the respiratory illness caused by the virus. 

According to a press release from the NIH, the first participant enrolled on Thursday in San Diego, California.  

The NIH has begun a clinical trial testing anti-malaria drug hydroxychloroquine (pictured) and antibiotic azithromycin in coronavirus patients

Researchers want to see if the combination of drugs can prevent hospitalization and death from COVID-19. Pictured: Nurses Albert Legayada (left) and Fred Bueno care for a COVID-19 patient in the ICU at Sharp Grossmont Hospital in La Mesa, California, May 6

Researchers want to see if the combination of drugs can prevent hospitalization and death from COVID-19. Pictured: Nurses Albert Legayada (left) and Fred Bueno care for a COVID-19 patient in the ICU at Sharp Grossmont Hospital in La Mesa, California, May 6

President Donald Trump has touted hydroxychloroquine in the past as a 'game-changer' in treating coronavirus. Pictured: Trump walks from Marine One to board Air Force One at Andrews Air Force Base, Maryland, May 14

President Donald Trump has touted hydroxychloroquine in the past as a ‘game-changer’ in treating coronavirus. Pictured: Trump walks from Marine One to board Air Force One at Andrews Air Force Base, Maryland, May 14

‘We urgently need a safe and effective treatment for COVID-19,’ said Dr Anthony Fauci, head of the NIH’s National Institutes of Health and Infectious Diseases. 

Repurposing existing drugs is an attractive option because these medications have undergone extensive testing, allowing them to move quickly into clinical trials and accelerating their potential approval for COVID-19 treatment.’

Fauci noted that there has been anecdotal evidence of hydroxychloroquine and azithromycin improving patients’ conditions.

However, he added: ‘Ee need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes.’ 

Study participants will randomly be assigned to take home either a combination of azithromycin and hydroxychloroquine – donated by Teva Pharmaceuticals Ltd –  or two placebos.

Those who’ve been given the experimental treat will take 400 milligrams (mg) of hydroxychloroquine twice on the first day and 200 mg twice daily for six days. 

Additionally, they will take 500 mg of azithromycin on the first day and 250 mg per day for four days.   

Participants will be asked to record their symptoms, how well they adhered to treatment, and any side effects they experienced over 20 days. 

Researchers will conduct either a telephone or in-person follow-up followed by one at three months and another at six months. 

President Donald Trump has repeatedly touted hydroxychloroquine, which is also used to treat lupus and rheumatoid arthritis.

Not long after, the US Food and Drug Administration (FDA) issued an emergency use authorization for the drug.  

However, reports began to emerge that has potentially serious side effects, including altering the heartbeat in a way that could lead to sudden death.

This lead to the FDA issuing a formal warning and advising that hydroxychloroquine not be used except in clinical trials and in hospital settings.

Current studies have offered mixed results.

A study from New York found that  patients received no benefits whether they took just the drug or paired it with azithromycin. 

Another found that when the drugs were paired with zinc, patients had a higher chance of covering well enough to be discharged and were less likely to die. 

Read more at DailyMail.co.uk