PASSReviewer 1· 95% conf
The trial design is rigorous: randomized, double-blind, placebo-controlled, with a pre-specified sample size calculation, clear inclusion/exclusion criteria, and appropriate analysis populations.
Evidence
direct quote[Methods, Trial Procedures]
“participants were randomly assigned in a 1:1 ratio with the use of an interactive response technology system to receive either nirmatrelvir–ritonavir (300 mg of nirmatrelvir and 100 mg of ritonavir) or placebo (consisting of inactive filler ingredients) every 12 hours for 5 days (10 doses in total). Randomization was stratified according to geographic region, vaccination status, and time of Covid-19 symptom onset (≤3 days vs. >3 to 5 days before randomization).”direct quote[Methods, Trial Design and Participants]
“Blinding was performed by Pfizer by means of overencapsulation.”direct quote[Methods, Statistical Analysis]
“Initially, we planned to enroll 1140 participants to ensure that 800 participants would be enrolled within 3 days after symptom onset, which would provide 90% power to detect a 25% difference in the time to sustained alleviation of all targeted Covid-19 signs and symptoms (8 days vs. 6 days), assuming that 18% of the participants would discontinue participation and that approximately 30% of the participants would undergo randomization more than 3 days after symptom onset.”direct quote[Methods, Trial Design and Participants]
“Eligible participants were at least 18 years of age and had reverse-transcriptase–polymerase-chain-reaction (RT-PCR)–confirmed or rapid antigen–confirmed SARS-CoV-2 infection and associated signs or symptoms of Covid-19 (Table S1 in the , available with the full text of this article at NEJM.org), with the onset of signs of symptoms occurring 5 or fewer days before randomization.”PASSReviewer 2· 95% conf
The trial design is rigorous: randomized, double-blind, placebo-controlled, with a pre-specified sample size calculation, clear inclusion/exclusion criteria, and appropriate analysis populations.
Evidence
direct quote[Methods, Trial Procedures]
“participants were randomly assigned in a 1:1 ratio with the use of an interactive response technology system to receive either nirmatrelvir–ritonavir (300 mg of nirmatrelvir and 100 mg of ritonavir) or placebo (consisting of inactive filler ingredients) every 12 hours for 5 days (10 doses in total).”direct quote[Methods, Trial Design and Participants]
“Blinding was performed by Pfizer by means of overencapsulation.”direct quote[Methods, Statistical Analysis]
“Initially, we planned to enroll 1140 participants to ensure that 800 participants would be enrolled within 3 days after symptom onset, which would provide 90% power to detect a 25% difference in the time to sustained alleviation of all targeted Covid-19 signs and symptoms (8 days vs. 6 days), assuming that 18% of the participants would discontinue participation and that approximately 30% of the participants would undergo randomization more than 3 days after symptom onset.”