Nirmatrelvir for Outpatients with Covid-19 | NEJM

Summary

A phase 2-3 clinical trial evaluated the oral antiviral nirmatrelvir combined with ritonavir for treating Covid-19 in fully vaccinated adults with risk factors and unvaccinated individuals. The treatment did not significantly reduce symptom alleviation time compared to placebo, with a primary endpoint of 12 days for the treatment group versus 13 for the placebo. Hospitalization or death rates were also similar between groups, and the most common side effects included dysgeusia, diarrhea, and nausea. The study's full results are available at NEJM.org.

Takeaways

• 🔬 The clinical trial focused on evaluating an oral antiviral treatment for Covid-19.
• 💊 The treatment in question was nirmatrelvir combined with ritonavir.
• 🎯 The trial included fully vaccinated adults with risk factors and unvaccinated adults without risk factors.
• 📈 The study was a phase 2–3, randomized, controlled trial involving 1296 participants.
• 📅 Participants were assigned to receive the treatment or placebo for 5 days, starting within 5 days of symptom onset.
• 📊 The primary end point was the time to sustained alleviation of Covid-19 symptoms, which was similar in both groups.
• 🏥 A secondary end point was Covid-19-related hospitalization or death, with no significant difference between the groups.
• 👨‍⚕️ Serious adverse events were reported at similar rates in both the treatment and placebo groups.
• 🤒 Common adverse events in the treatment group included dysgeusia, diarrhea, and nausea.
• 📉 The authors concluded that the treatment did not significantly shorten the time to symptom alleviation in the studied population.
• 🔗 Full trial results are available for reference at NEJM.org.

Q & A

What is the purpose of the clinical trial mentioned in the script?

The purpose of the clinical trial is to assess the efficacy and safety of the oral antiviral nirmatrelvir in combination with ritonavir for the treatment of Covid-19 in fully vaccinated adults with at least one risk factor for severe Covid-19, and in adults without risk factors who had never been vaccinated or had not been vaccinated within the previous year.

What was the primary endpoint of the trial?

The primary endpoint of the trial was the time to sustained alleviation of all targeted signs and symptoms of Covid-19.

How long did it take for the primary endpoint to be achieved in the nirmatrelvir–ritonavir group and the placebo group?

The primary endpoint was achieved in 12 days in the nirmatrelvir–ritonavir group and 13 days in the placebo group.

Was the difference in time to symptom alleviation between the two groups statistically significant?

No, the difference in time to symptom alleviation between the nirmatrelvir–ritonavir group and the placebo group was not statistically significant.

What was the key secondary endpoint of the trial?

The key secondary endpoint was Covid-19-related hospitalization or death from any cause through day 28.

How many participants were hospitalized or died in each group by day 28?

Five participants in the nirmatrelvir–ritonavir group and 10 in the placebo group were hospitalized for Covid-19 or died.

Was there a significant difference in the rate of hospitalization or death between the two groups?

No, the difference in the rate of hospitalization or death between the nirmatrelvir–ritonavir group and the placebo group was not statistically significant.

What were the rates of serious adverse events reported in the trial?

The rates of serious adverse events were similar in both the nirmatrelvir–ritonavir group and the placebo group.

What were the most commonly reported adverse events in the nirmatrelvir–ritonavir group?

The most commonly reported adverse events in the nirmatrelvir–ritonavir group were dysgeusia (distorted sense of taste), diarrhea, and nausea.

What was the conclusion of the authors regarding the effectiveness of nirmatrelvir and ritonavir?

The authors concluded that among standard-risk outpatients or vaccinated high-risk outpatients with Covid-19, nirmatrelvir and ritonavir did not significantly shorten the time to symptom alleviation.

Where can the full trial results be found?

The full trial results are available at NEJM.org.