Gilead’s Second Batch Of Remdesivir Antivirals Arrives In Wuhan For Clinical Trials Against Coronavirus
Source: Thailand Medical News Feb 16, 2020 4 years, 10 months, 1 week, 2 hours, 12 minutes ago
Gilead’s second batch of
antiviral drug,
Remdesivir which was dispatched through FedEx has arrived in
Wuhan to be used for two ongoing clinical trials against the
SARS-CoV2 coronavirus that that has so far killed more than 1,670 people as a result of the
Covid-19 disease that it causes.
The experimental drug is to be tested on a total of 760 patients. A total of 5000 drug doses and 1,400 placebo doses were apparently shipped according to sources. This are in addition to some 3,400 doses of the drug and 900 placebo doses that reached Wuhan’s Jinyintan hospital last week that has already progressed to Phase 3 trials, which had begun on Feb. 6.
The drug trials are randomized, controlled and double-blinded, meaning neither physicians nor their patients know whether they are using the active drug or a placebo, so that medical researchers can determine whether patients truly benefited from the new treatment or recovered on their own.
Physicians and patients will, however, be alerted if they suffer a serious adverse reaction through a remote monitoring programme that
Gilead has put into place.
To date
remdesivir has not been approved anywhere in the world to treat any condition though it was originally created to treat Ebola.
According to Australian infectious disease researcher and
antiviral drug specialist Dr Tony Cunningham,
remdesivir by
Gilead has performed well in laboratory trials against other types of
coronavirus including SARS and MERS.
It has also been found to be effective at killing the
SARS-CoV2 virus which causes
Covid-19 in the lab.
Dr Cunningham however warned evidence of its effectiveness in humans remains slim despite an American patient diagnosed with
Covid-19 who was treated with it and recovered. Subsequent study of that case revealed that the patient already shown signs of improvement even before the drug was administered, illustrating the need for proper well-designed clinical trials with control cases, even if it means some people in the trial will go without the drug.
The ongoing trials of
remdesivir in China have been registered on the U.S. trial registry ClinicalTrials.gov, with the records showing one is for severe cases of
Covid-19 and one for mild and moderate cases.
Dr Cao Bin of Beijing's China-Japan Friendship Hospital is leading the trials.
The hospital says that the first trial on 452
patients with severe
Covid-19 who have had the disease for at least 12 days, is expected to conclude on May 1.
The other trial on 308 patients with mild to moderate
Covid-19, is expected to conclude on April 27.
Patients in both trials are required not to be involved in studies of any other experimental drugs for at least 28 days, and they must also agree to be “randomized,” meaning they will not know whether they are receiving the drug or a placebo.
Every patient in the trial will be given 200 mg of either
remdesivir or the placebo on the first day of treatment, and 100 mg each day after that via an intravenous drip for nine days, the records say.
Currently more than 82 clinical trials related to
Covid-19 are ongoing in China, but the
remdesivir trials are the only Phase 3 trials so far approved by Chinese authorities.
Every prospective drug or treatment protocol will need to prove its effectiveness and safety before authorities make any decision on whether to approve its general use.
Gilead’s
remdesivir trials are backed by Capital Medical University in collaboration with the Chinese Academy of Medical Sciences.
Meanwhile, virologists are also worried the evolving
coronavirus could mutate drastically which could render discovered treatments and even vaccines useless if it does.
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