Novartis Plans Phase III Trial of Hydroxychloroquine - COVID-19 Clinical Trial
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Novartis Plans Phase III Trial of Hydroxychloroquine

Novartis said today it will carry out a Phase III trial assessing hydroxychloroquine as a treatment for hospitalized patients with COVID-19—a study whose clinical data could strengthen or weaken the case for one of the drugs promoted by President Donald Trump as “a game changer” against the virus. 

The company said it reached agreement with the FDA to launch a randomized, double-blind, placebo controlled study, which will recruit approximately 440 patients and use a supply of hydroxychloroquine to be donated by Novartis’ Sandoz generics and biosimilars division. The trial will be conducted at more than a dozen sites in the U.S., Novartis said. Enrollment of patients will begin “within the next few weeks,” Novartis said, adding that it was committed to reporting results “as soon as possible.”

Gilead Coronavirus Drug Suggests Patients are Responding to Treatment 

A Chicago hospital treating severe Covid-19 patients with Gilead Sciences’ antiviral medicine remdesivir in a closely watched clinical trial is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, STAT has learned. 

Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes Covid-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against the disease. 

Inovio to Begin Phase 1/2 Clinical Trial of COVID-19 Vaccine 

South Korea based International Vaccine Institute (IVI) has announced that the Coalition for Epidemic Preparedness Innovations (CEPI) has granted $6.9 million funding to US based INOVIO to work with IVI and the Korea National Institute of Health (KNIH) for a Phase 1/2 clinical trial of INOVIO’s COVID-19 vaccine candidate (INO-4800) in South Korea. 

IVI will conduct the trial in parallel to INOVIO’s Phase 1 INO-4800 study currently underway in the US since April 6, 2020 with 40 healthy adults receiving the vaccine candidate and eventually expanding to older adults. 

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