Remdesivir has little to no effect on Covid-19 patients’ chances of survival, a WHO study on the anti-viral drug has found.
The WHO’s Solidarity clinical trial evaluated four potential medications for Covid-19, including hydroxychloroquine and remdesivir.
Remdesivir was among the first to be used to treat Covid-19, and was recently given to President Donald Trump when he was in hospital.
The company manufacturing the anti-viral drug, Gilead Sciences Inc., rejected the findings of the trial.
In a statement, Gilead said the findings of the study were “inconsistent” with others, and that it was “concerned” that the results have yet to be reviewed.
For the Solidarity clinical trial, the WHO tested the effects four potential treatments – remdesivir, an Ebola drug, was one, but they also looked at malaria drug hydroxychloroquine, auto-immune drug interferon, and the HIV drug combination of lopinavir and ritonavir.
Dexamethasone, a low-cost steroid now widely used on Covid patients in intensive care in many countries, was not included in this study.
The four drugs were tested with 11,266 adult patients in total, across 500 hospitals in more than 30 different countries.
The results, which are yet to be peer-reviewed, suggest that none of these treatments has a substantial effect on mortality or on the length of time spent in hospital, the WHO said on October 15.
On October 14, WHO chief scientist Soumya Swaminathan said that their trials on hydroxychloroquine and lopinavir/ritonavir were stopped in June because they had already proven ineffective. However, the other trials continued.
The study’s results appear to contradict a previous study from earlier this month, conducted by Gilead, which concluded that treatment with remdesivir cut Covid recovery time by five days compared to patients given a placebo. About 1,000 patients took part in that trial.
Gilead dismissed the findings, saying in a statement: “The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir.
“We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”
Remdesivir was given emergency use authorization in the US from the FDA on May 1and has since been authorized for use in several other countries.
Dexamethasone could be of huge benefit in poorer countries with high numbers of Covid-19 patients.
PM Boris Johnson said there was a genuine case to celebrate “a remarkable British scientific achievement”, adding: “We have taken steps to ensure we have enough supplies, even in the event of a second peak.”
About 19 out of 20 patients with coronavirus recover without being admitted to hospital.
Of those who are admitted, most also recover but some may need oxygen or mechanical ventilation.
These are the high-risk patients dexamethasone appears to help.
Dexamethasone is already used to reduce inflammation in a range of other conditions, including arthritis, asthma and skin some conditions.
It appears to help stop some of the damage that can happen when the body’s immune system goes into overdrive as it tries to fight off coronavirus.
This over-reaction, a cytokine storm, can be deadly.
In the trial, led by a team from Oxford University, about 2,000 hospital patients were given dexamethasone and compared with more than 4,000 who were not.
For patients on ventilators, the drug cut the risk of death from 40% to 28%.
For patients needing oxygen, dexamethasone cut the risk of death from 25% to 20%.
Dexamethasone does not appear to help people with milder symptoms of coronavirus who do not need help with their breathing.
Asked what was his evidence of hydroxychloroquine’s positive benefits, President Trump said: “Here’s my evidence: I get a lot of positive calls about it.”
He added: “I’ve heard a lot of good stories [about hydroxychloroquine] and if it’s not good, I’ll tell you right I’m not going to get hurt by it.”
Though some people in the White House have tested positive for coronavirus, President Trump said again he had “zero symptoms” and was being tested frequently.
He added that he had been taking a daily zinc supplement and received a single dose of azithromycin, an antibiotic meant to prevent infection.
When asked whether the White House physician had recommended he start taking the disputed remedy, President Trump said he himself had requested it.
Dr. Sean Conley, physician to the president, said in a statement issued through the White House later on May 18 that President Trump was in “very good health” and “symptom-free”.
The US Navy officer added: “After numerous discussions he and I had regarding the evidence for and against the use of hydroxychloroquine, we concluded the potential benefit from treatment outweighed the relative risks.”
The FDA last month issued an advisory saying that hydroxychloroquine has “not been shown to be safe and effective”.
The agency cited reports that the drug can cause serious heart rhythm problems in Covid-19 patients.
The FDA warned against use of the medication outside hospitals, where the agency has granted temporary authorization for its use in some cases. Clinical trials of the drug are also under way.
The CDC says there are no approved drugs or therapeutics to prevent or treat Covid-19, which is confirmed to have infected more than 1.5 million people in the US, killing more than 90,000 patients.
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