“Preliminary results from this trial suggest that a 10-day course of remdesivir was superior to placebo in the treatment of patients hospitalized with Covid-19,” the researchers wrote. But it was not a remedy and it did not act quickly.
“These preliminary results support the use of remdesivir for patients hospitalized with Covid-19 who require additional oxygen therapy,” wrote the researchers, led by a team from the National Institute of Allergies and Infectious Diseases.
“However, given the high mortality despite the use of remdesivir, it is clear that treatment with an antiviral medication alone is unlikely to be sufficient,” they added. “Future strategies should evaluate antiviral agents in combination with other therapeutic approaches or combinations of antiviral agents to continue improving patient outcomes in Covid-19. “
Other teams are already combining antiviral drugs, including remdesivir, with immunomodulatory drugs in patients with coronavirus. NIAID says it has started a trial to compare remdesivir alone with remdesivir in combination with the anti-inflammatory drug baricitinib, which is used to treat rheumatoid arthritis.
The study also showed that it is important to start treatment early.
“Our results highlight the need to identify cases of Covid-19 and start antiviral therapy before lung disease progresses to require mechanical ventilation,” wrote NIAID clinical researchers, Dr. John Beigel, Dr. Clifford Lane and their team.
At the end of last month, the federal government announced that the drug was helping and the United States Food and Drug Administration granted an emergency use authorization to remdesivir to treat Covid-19.
“Even though the trial was underway, the data and security oversight committee recommended disclosing the results to members of the NIAID test team, who subsequently decided to release the results to the public” , wrote the researchers.
“Given the robustness of the results for remdesivir, these results were deemed to be of immediate importance for the care of patients who continue to participate in the trial as well as those outside the trial who may benefit from ‘treatment with remdesivir.’
The study results were deemed important as it was the first double-blind, placebo-controlled trial to test the drug in patients. This means that some patients did not receive any medication, and neither the patient nor the doctors knew who would receive the real treatment.
But some critics have complained that the data were not released and feared the federal government would rush the results.
The team tested 1,063 patients. They found those who had recovered the infused drug after an average of 11 days. Those who received a placebo took an average of 15 days to recover. As previously reported, 7% of patients who received remdesivir died, compared to 11.9% who received placebo infusions. But these results were not statistically significant.
Patients who needed oxygen appeared to benefit the most from the drug, the researchers reported.
Remdesivir has not caused too many side effects and seems safer than placebo, they added.
“Forty-nine patients stopped treatment with remdesivir before the 10th day due to an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew his consent (13 patients) Writes the team.
“Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group,” the researchers wrote.
Launching a clinical trial in the middle of a pandemic has been a daunting task, the research team said.
“The trial was carried out during a period of restricted travel and hospitals have restricted the entry of non-essential staff,” they wrote.
“Training, initiation visits and follow-up visits were often carried out remotely. Research staff were often assigned other clinical duties, and staff illnesses overwhelmed research resources. However, the research teams were motivated to find creative solutions to overcome these challenges. “
The study is still ongoing. “Our preliminary report is intended to help clinicians consider the use of remdesivir,” the researchers wrote. “We are awaiting the final visits, data entry, monitoring and data locking for the last of 1,063 patients enrolled, after which an update of the results will be provided.” “