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WHO Stops Covid-19 Hydroxychloroquine Trial – What’s Next for a Vaccine?

The World Health Organization halted drug trials using hydroxychloroquine for Covid-19 patients on Monday May 25, due to safety concerns. Currently vaccine trials for Covid-19 in the United States are using hydroxychloroquine.

The Debate on Hydroxychloroquine

The WHO was triggered to shut down their HCQ trials after Lancet Medical Journal reported findings that HCQ had negatively impacted patients.

The Lancet medical journal reported on May 22 that patients getting hydroxychloroquine (HCQ) were dying at higher rates than other coronavirus patients.

Hydroxychloroquine was being used on 3,500 patients in the Solidarity Trial for treatment of Covid-19 patients in the hospital. HCQ is not for the prevention of Covid-19.

Other trials for HCQ have also shown negative findings which such as the Jama Network and The New England Journal of Medicine.

The Jama Network did an original investigation with findings that patients with HCQ treatment with our without azithromycin or both HCQ and azithromycin had no significant difference in mortality rates.

According to JamaNetwork.com, ” In a retrospective cohort study of 1438 patients hospitalized in metropolitan New York, compared with treatment with neither drug, the adjusted hazard ratio for in-hospital mortality for treatment with hydroxychloroquine alone was 1.08, for azithromycin alone was 0.56, and for combined hydroxychloroquine and azithromycin was 1.35. None of these hazard ratios were statistically significant.”

The New England Journal of Medicine had similar findings to the Jama Network. NEJM concluded that patients needs for ventilators was not reduced and death rates were unaffected.

USA Hydroxychloroquine Trials

The United States President advocated for the use of hydroxychloroquine (HCQ) without further studies back in April.

Since then the Food and Drug Administration (FDA) did an emergency approval on March 22 for HCQ for experimental treatment trials in hospital settings.

One month later on April 24, the FDA posted a caution about HCQ and its risk of heart rhythm problems.

Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases, has said in multiple press conferences that evidence of hydroxychloroquine’s effectiveness is anecdotal at best.

On May 14 The National Institute of Allergy and Infectious Diseases started a hydroxychloroquine and azithromycin trial for Covid-19 in the United States.

The United States is continuing its trials using HCQ in search of a vaccine. The United States President has not made remarks on shutting down current trials or WHO’s findings on hydroxychloroquine.

Hospitals demand for the drug has dropped as physicians have grown weary to prescribe HCQ, concerned about the lack of data and side effects.

Searching for a Vaccine

The first human to be injected with a potential vaccine was March 16. The vaccine was created by Moderna and will take 14 months in trial on 45 healthy people.

Vaccine development, testing, approval, production and distribution can take anywhere from 18 months to two years.

Currently no vaccine has passed clinical trials for Covid-19.

Image from Lew rockwell.
*Population data 2018 Statista
**
Daily Mail UK, March 6, 2020 (James Lawler, Univ. Nebraska)
***
Open Forum Infectious Diseases Jan. 12, 2017 (flu vaccination data)
****
New England Journal Medicine, March 7, 2020 (15 of 1099 hospitalized for flu patients died/China)

Current Hydroxychloroquine Trials in the United States

USNews.com reported the following list of some HCQ trials and their current status:

** University of Minnesota is leading two nationwide studies comparing hydroxychloroquine to placebo for preventing infection in 3,000 people exposed to the coronavirus and for alleviating symptoms if COVID-19 develops. Some results are expected this week.

** University of Washington is conducting a seven-center trial for treatment of COVID-19 in 630 high-risk adults not requiring hospitalization; participants will be given HCQ + placebo, HCQ + azithromycin, or just a placebo.

Estimated study completion date: October 2020.

** Cambridge University Hospitals NHS Foundation Trust is conducting a trial that aims to determine whether HCQ is better than placebo for preventing COVID-19 in 1,000 frontline healthcare workers at hospitals and care homes in the UK.

Estimated study completion date: April 2021.

** A U.S. National Heart, Lung and Blood Institute trial involving 510 hospitalized COVID-19 patients is testing whether 15 days of hydroxychloroquine is more helpful than placebo.

Estimated study completion date: July 2021.

** A European study, code-named Discovery and conducted by French research institute Inserm, will treat 3,100 adult patients in 34 hospitals, providing usual care plus either hydroxychloroquine, remdesivir, interferon beta-1a, a combination of lopinavir/ritonavir, or none of those drugs. (https://bit.ly/3gikLTU)

Estimated study completion date: March 2023.

Source: Reuters reporting, clinicaltrials.gov, government press releases

(Reporting by Ankur Banerjee, Vishwadha Chander and Mrinalika Roy in Bengaluru; Editing by Nancy Lapid, Lewis Krauskopf and Matthew Lewis)

Copyright 2020 Thomson Reuters.

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WHO Stops Covid-19 Hydroxychloroquine Trial - What's Next for a Vaccine?