A trial of the antiviral drug remdesivir has produced ‘positive data’ for treating coronavirus patients, its maker, Gilead Sciences, said Wednesday.
Gilead announced the results of a clinical trial testing the drug, which was originally developed to treat Ebola patients, in people severely ill with coronavirus.
Half of the 397 patients, who were sick enough to need additional oxygen, but not to be placed on ventilators, improved within 10 days of a five-day treatment course and those who were on a 10-day regimen were better by the eleventh day.
More than half of the patients were discharged from the hospital within two weeks, Gilead announced in a press release.
Gilead Science’s remdesivir showed promising trial results after the company announced Wednesday that more than half of patients treated with the drug recovered within two weeks
WHAT IS REMDESIVIR AND DOES IT WORK AGAINST CORONAVIRUS?
Remdesivir was developed by Gilead Sciences to treat Ebola, the deadly hemorrhagic fever that emerged in West Africa in 2014.
Ebola, like COVID-19, is caused by a virus, and scientists are now testing remdesivir to treat coronavirus patients, but it’s too soon to know if the drug works or not.
Remdesivir produced encouraging results earlier this year when it showed promise for both preventing and treating MERS – another coronavirus – in macaque monkeys.
The drug appears to help stop the replication of viruses like coronavirus and Ebola alike.
It’s not entirely clear how the drug accomplishes this feat, but it seems to stop the genetic material of the virus, RNA, from being able to copy itself.
That, in turn, stops the virus from being able to proliferate further inside the patient’s body.
NIH researchers in charge of the macaque study recommended that it move ahead to human trials with the new coronavirus.
Scientists have listened, and human trials for remdesivir first began in Nebraska.
Most recently, researchers trialing the drug at the University of Chicago reported that most of the 125 COVID-19 patients they’d teated with the drug had been discharged from the hospital, according to Stat News.
Two patients died over the course of the trial.
Remdesivir has been among the top contenders of existing drugs being trialled for treating coronavirus, although World Health Organization documents leaked last week suggested it had failed to help patients in a more than 200-person trial recover.
Gilead defended the trial, saying it believed the leaked data was a ‘mischaracterization’ of the study’s results.
It’s unclear whether the newly-announced results are from the same trial.
For the phase 3 trial announced Wednesday, Gilead treated 397 severely ill patients with its antiviral drug.
The company’s Wednesday press release did not specify the locations of the patients. However, it announced in March the initiation of two trials of the drug, one of which would study 400 patients in the Hubei Province of China, where coronavirus first emerged.
The ages and sexes of those patients were not disclosed.
The company tried two different treatment regimens for severely ill coronavirus patients – a five-day and 10-day course – but did not include a control arm of patients who did not receive the drug.
COVID-19 is considered ‘severe’ if a patient is hospitalized and needs supplemental oxygen.
Among those who were treated for five days, 60 percent could go home by day 14.
In the 10-day treatment group, 52 percent were discharged within two weeks.
Full recovery was achieved on the same timeline by 53.8 percent of the 10-day treatment group, and by 64.5 percent of people in the five-day treatment group.
‘These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,’ said Dr Aruna Subramanian, a Stanford University infectious diseases professor who helped lead the study.
Gilead is expanding upon the study by testing the drug in a further 5,600 patients at 180 locations for the next stage of its SIMPLE trial.
It will be trialled around the world, including in the US, the UK, China, France, Germany, Hong Kong, Italy, Japan Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, and Taiwan.
These trials will include patients who need mechanical ventilation to survive as well, and will compare the two treatment regimens (five- and 10-day courses) to those given the standard of supportive care.
Gilead said it expects to report results on the first 600 patients involVed by the end of May.
‘While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.’
That’s not to say that there weren’t patients who fared poorly.
Seven percent of coronavirus patients treated outside Italy died. It’s not clear how many patients were treated within Italy versus outside of the hard-hit nation.
Timing mattered as well.
People who were treated early – within 10 days of their first symptoms – fared better, with 62 percent being discharged from the hospital within 14 days.
Severely ill coronavirus patients, like those treated in the remdesivir trial, require oxygen to keep them alive, including mechanical ventilation (pictured). Safe treatments for these people are badly needed, as an estimated 80% of those put on ventilators will not survive (file)
Gilead Sciences was dealt a blow last week when leaked data suggested that remdesivir was not helping coronavirus patients, but this week’s trial results suggest otherwise
But the trial’s results suggest the drug may still be beneficial, even if given relatively late. Nearly half of those who received remdesivir 10 or more days after they developed symptoms were also released from the hospital by day 14.
Generally speaking, the drug appeared safe in the trial, regardless of the duration of the treatment course.
More than 10 percent of patients treated with the antiviral became nauseous, and six percent of the five-day treatment group and 10.7 percent of the 10-day treatment group were in acute respiratory failure (also a complication of the infection itself).
The greatest risk posed to the coronavirus patients treated with remdesivir was liver damage.
Lab work showed enzyme build up in 7.3 percent of the patients. the risk of liver damage became great enough that three percent were removed from the trial.
DOW JUMPS 400 POINTS AFTER GILEAD REPORTED ‘POSITIVE DATA’ FOR ITS EXPERIMENTAL CORONAVIRUS TREATMENT
US. stock indexes jumped on Wednesday after Gilead Sciences said its experimental antiviral drug met the main goal of a trial testing it in COVID-19 patients.
At 9.31am, the Dow Jones Industrial Average was up 424.89 points, or 1.76 percent, to 24,526.44. The S&P 500 was up more than 1 percent and Nasdaq composite rose more than 2 percent.
The jump came after Gilead said Wednesday that preliminary results of a coronavirus drug trial showed at least 50 percent of patients treated with a 5-day dosage of antiviral drug remdesivir improved and more than half were discharged from the hospital within two weeks.
Markets have been watching closely for any sign of when Americans will be able get back to work, and immediately rose at the prospect of an effected treatment for the virus that has shuttered the economy.