A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir in Adults with Long COVID.

Summary

This decentralized trial is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled study in an anticipated 100 non-hospitalized highly symptomatic adult participants with long COVID. It seeks to determine the efficacy, safety, and tolerability of 15 days of Paxlovid (nirmatrelvir/ritonavir), an anti-viral agent, compared with placebo plus ritonavir. The hypothesis is that viral persistence contributes to long COVID in some patients and nirmatrelvir/ritonavir compared with placebo/ritonavir can improve general health status in participants with long COVID. The study will also seek immune signatures associated with treatment response (overseen by Professor Akiko Iwasaki). The decentralized study does not require site visits, and participants in all 48 states including the District of Columbia, who meet entry criteria can enroll. It is designed to make it convenient to participate. The study drugs will be delivered to the participant's designated address. Long COVID is also known as post-acute sequelae of SARS-CoV-2 (PASC).

Timeline

Start

2023-04-14

Primary completion

2024-04-09

Completion

2024-08-21

Publications

• Sawano M, Bhattacharjee B, Caraballo C, Khera R, Li SX, Herrin J, Christian D, Coppi A, Warner F, Holub J, Henriquez Y, Johnson MA, Goddard TB, Rocco E, Hummel AC, Mouslmani MA, Hooper WB, Putrino DF, Carr KD, Charnas L, De Jesus M, Nepert D, Abreu P, Ziegler FW 3rd, Spertus JA, Iwasaki A, Krumholz HM. Nirmatrelvir-ritonavir versus placebo-ritonavir in individuals with long COVID in the USA (PAX LC): a double-blind, randomised, placebo-controlled, phase 2, decentralised trial. Lancet Infect Dis. 2025 Aug;25(8):936-946. doi: 10.1016/S1473-3099(25)00073-8. Epub 2025 Apr 3.

Drugs

Indications