On April 10, Gilead published the first clinical research results of Remdesivir in the treatment of new coronavirus pneumonia (COVID-19) in the "New England Medicine" magazine.
The results showed that Remdesivir brought clinical improvement to 68% (36 patients) of 53 severe and dangerous recurrent coronavirus pneumonia patients from the United States, Europe, Canada and Japan.
Among them, 57% (30/53) of patients who received mechanical ventilation had 17 extubated.
A total of 47% (25/53) of patients were discharged and 13% (7/53) of patients died; among patients receiving invasive ventilation, the mortality rate was 18% (6/34), while patients not receiving invasive ventilation It is 5% (1/19).
The above-mentioned patients were all treated with Remdesivir under sympathetic medication.
According to the treatment plan, these 53 critically ill patients will receive a 10-day Remdesivir treatment, followed by an 18-day follow-up period.
The data released by this study is as of March 30, 2020. Of the 53 patients able to be evaluated, 40 (75%) received 10 days of treatment, 10 (19%) received 5-9 days of treatment, and 3 (6%) received less than 5 treatments day.
In terms of safety, a total of 32 patients (60%) have side effects, the most common of which are elevated liver enzymes, diarrhea, rash, renal dysfunction, and hypertension.
A total of 12 (23%) patients experienced severe side effects, including multiple organ multiple organ dysfunction syndrome, septic shock, acute kidney injury, and hypertension.
In addition, 7 of the 53 patients receiving treatment died after completing Remdesivir treatment, including 6 patients receiving invasive ventilation and 1 patient receiving non-invasive oxygen support.
The author of the paper pointed out that this study provides the latest data on the treatment of critically ill patients with Remdesivir. Oxygen support was improved in 68% of patients, and the overall mortality rate was 13% at a median follow-up of 18 days.
Previously, in a series of studies conducted in China, the mortality rate of critically ill patients was between 17-78%. In a study of 201 patients in Wuhan, the mortality rate of patients receiving invasive ventilation was as high as 66% (44/67).
The author said that compared with these figures, the 13% mortality rate is worthy of attention.
On February 5 this year, Gilead has reached an agreement with the Chinese health department to support the launch of two clinical trials for 2019-nCoV infected persons. The trial is under the responsibility of Wang Chen and Cao Bin's team and is scheduled to end on April 27.
One study evaluated the therapeutic effect of Remdesivir for patients diagnosed with 2019-nCoV infection and had been hospitalized but did not show significant clinical symptoms (eg, additional oxygen inhalation), and the other study evaluated Remdesivir for more severe clinical manifestations. Symptoms (eg, need for oxygen inhalation) confirm the efficacy of the patient.
At the previous press conference, the Deputy Director of the State Intellectual Property Office He Zhimin said that the clinical trials of Remdesivir conducted in many hospitals in Wuhan will announce the results on April 27.
"We are very concerned about the effectiveness and safety of Remdesivir, and look forward to the emergence of a batch of drugs including Remdesivir that can have a positive effect on the treatment of new coronavirus pneumonia as soon as possible."
On April 5, Gilead Science Chairman and CEO Daniel O'Day said in an open letter that in the past week, Gilead has been consulting with regulatory agencies to establish a new treatment for Remdesivir, a potential coronavirus pneumonia drug. More expanded access options.
Through this program, hospitals or doctors can apply for emergency use of Remdesivir for multiple critically ill patients at the same time. These patients cannot participate in clinical trials, however, "emergency" is the truest description for them, their families, and the medical staff who provide them with treatment.
Since the outbreak of the new coronavirus pneumonia, Remdesivir has been regarded as the most potential drug in research. After the World Health Organization inspected the epidemic in China, Remdesivir may be the only effective drug for the treatment of new coronavirus pneumonia.
In January this year, based on the principle of "sympathetic medicine", American researchers used Remdesivir on a person infected with a new coronavirus, and the patient's symptoms improved significantly within a day or two, making this drug highly regarded.
Gilead emphasized that the company must take a responsible and ethical approach to determine whether Remdesivir is indeed a safe and effective treatment plan. According to the plan previously disclosed by the company, they will disclose some clinical data in early April.
Currently, patients can obtain Remdesivir through clinical trials, sympathetic medication and other channels.
Daniel O'Day stated in the above-mentioned open letter that Gilead 's existing supply of Remdesivir currently includes 1.5 million doses, including finished products ready for distribution and drugs under study at the final production stage.
Gilead is providing free medicines for the treatment of severe patients with new coronavirus pneumonia.
"The 1.5 million doses of medicines can be used in clinical trials, sympathetic medicines, and expanded access programs, and donated to be widely used after possible regulatory approval in the future. These medicines can be administered by intravenous injection in hospitals every day for treatment Patients with severe symptoms. "
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