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The Following is a summary of “nirmaretrelvir-ritonavir versus placebo-ritonavir in individuals with long covid in the USA (pax LC): a double-blaind, randomised, placebo-controlled, phase 2, decentralied trial,” published in the april 2025 ISSUE OF OF Lancet Infectious Diseases by Sawano et al.
Researchers Drive the Retrospective Study to Evaluate The Effficacy, Safety, and Tolerability of Nirmarlvir-ritonavir in Treating Post-Covid-19 Condition (Long Covid).
They Caried Out a Randomized Controlled Trial (RCT) Across 48 Continued US States, Adults (AGED ≥18 Years) with documentimed sars-cov-2 infection and long covid symptoms Persisting for at Least 12 Weeks. EXCLUSION CRITERIA INCLUDED NIRMARELVIR-ARITONAVIR USE WETIN 2 Fions, CYP3A4-Dependent Medications or Strong Indurs, Acute Illness Such As Sars-Cov-2 Infection in the Past 2 Weeks, Active Liver Disease, Renal Impairment, and ImmunePromise. Participants Were Randomly Assigned (1: 1) via Stratified Block Randomization Software to Receive Either Nirmalvir (150 mg, 2 tablets) Plus Ritonavir (100 mg) or placebo Plus Ritonavir (100 mg), Taken Orally Twice Daily for 15 days, Stratified BY AGE, Sex at Birth, and Covid-19 Vaccination Status. Blinding was maintained for participants, clinicians, and the study team. The Primary Efficacy Endpoint was the Change in the Patient-Reported Outcomes Measurement Information System (Promis) -29 Physical Health Summary Score (PHSS) from Baseline to Day 28, Analyzed by Intention to Treat. Safety Outcomes Were Monitored from Baseline to Week 6. This trial was registered with clinicaltrials.gov (NCT0568091).
The Results Showed that from April 14, 2023, to February 26, 2024, 119 Individuals Were Screened, and 100 Were Enrolled (66% Female (66 of 100), 34% Male (34 of 100)). The Nirmarlvir-ritonavir Group Included 49 Individuals, While the placebo-ritonavir group Had 51 (Intenti-to-Treat Population), 5 Whdrew Before Treatment Initiation (3 in the nirmalvir-ritonavir group, 2 in the placebo-ritonavir goup) and were excluded from The Safety Analysis. The Mean Promis-29 pHS at Baseline Was 39.6 (95% CI, 37.4 to 41.9) In The Nirmarlvir-ritonavir Group and 36.3 (95% CI, 34.4 to 38.2) In the placebo-ritonavir group. ADJUSTED CHANGES FROM Baseline to Day 28 WERE 0.45 (95% CI, –0.93 TO 1.83) FOR NIRMARELVIR – ARITONAVIR AND 1.01 (95% CI, -30 TO 2.31) FOR PLACEBORTONAVIR (ADJUSTED MEAN DIFFERENCE, –0.55 (95% CI, –2.32 TO 1.21); P = 0.54). At Deaths or Serious Adverse Events (AES) Occred Throud Week 6. Treatment-Esmergent aes Were More Frequent with Nirmarlvir-ritonavir (76% (35 of 46)) Than placebo-ritonavir (55% (27 of 49)), primarily due to dysgeusia. Treatment Discontinuation Due to Aes Occrede in 2 Individuals Receueving Nirmalvir – ritonavir and 1 receiving placebo – ritonavir.
Investigators Concluded that a 15-day course of nirmalvir-ritonavir did not improve long covid Outcomes compared to placebo-ritonavir at 28 days.
Source: Thelancet.com/journals/lanif/article/piis1473-3099(25)00073-8/fulltext
