STOP-PASC
Trial question
What is the role of nirmatrelvir/ritonavir in patients with post-acute sequelae of COVID-19 infection?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
59.0% female
41.0% male
N = 155
155 patients (92 female, 63 male).
Inclusion criteria: adult patients with at least 3 months of moderate-to-severe post-acute sequelae of COVID-19 symptoms.
Key exclusion criteria: pregnancy or lactation; severe liver disease; acute COVID-19 infection; receipt of COVID-19-specific treatment within 30 days, COVID-19 vaccination within 28 days or other vaccine within 14 days of randomization; receipt of medications interacting with the study drug.
Interventions
N=102 nirmatrelvir/ritonavir (oral dose of 300/100 mg BID for 15 days).
N=53 placebo and ritonavir (matching oral placebo and ritonavir BID for 15 days).
Primary outcome
Reduction in severity of 6 core COVID-19 symptoms including fatigue, brain fog, shortness of breath, body aches, gastrointestinal symptoms, and cardiovascular symptoms at 10 weeks
23.02%
28%
28.0 %
21.0 %
14.0 %
7.0 %
0.0 %
Nirmatrelvir/ritonavir
Placebo and
ritonavir
No significant
difference ↔
No significant difference in reduction in severity of 6 core COVID-19 symptoms including fatigue, brain fog, shortness of breath, body aches, gastrointestinal symptoms, and cardiovascular symptoms at 10 weeks (23.02% vs. 28%; AD -4.98%, 95% CI -10.18 to 0.22).
Secondary outcomes
Borderline significant decrease in Patient Global Impression of Change score at 10 weeks (3.38 points vs. 3.13 points; B 0.1, 95% CI -0.48 to 0.67).
Borderline significant decrease in Patient Global Impression of Severity score at 10 weeks (4 points vs. 3.79 points; B 0.19, 95% CI -0.25 to 0.62).
No significant difference in the percentage of patients experiencing relief at 10 weeks (32.4% vs. 41.5%; OR 0.55, 95% CI 0.27 to 1.09).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In adult patients with at least 3 months of moderate-to-severe post-acute sequelae of COVID-19 symptoms, nirmatrelvir/ritonavir was not superior to placebo and ritonavir with respect to reduction in severity of 6 core COVID-19 symptoms including fatigue, brain fog, shortness of breath, body aches, gastrointestinal symptoms, and cardiovascular symptoms at 10 weeks.
Reference
Linda N Geng, Hector Bonilla, Haley Hedlin et al. Nirmatrelvir-Ritonavir and Symptoms in Adults With Postacute Sequelae of SARS-CoV-2 Infection: The STOP-PASC Randomized Clinical Trial. JAMA Intern Med. 2024 Sep 1;184(9):1024-1034.
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