Paxlovid for Treatment of Long Covid

Summary

The purpose of this study is to compare whether being treated with nirmatrelvir plus ritonavir for 15 days works better than being treated with placebo plus ritonavir to reduce severe symptoms of Long Covid. Participants will have 5 planned visits to the study clinic over 15 weeks and will take the drug (or placebo) for the first 15 days. This study uses the term post-acute sequelae of SARS-CoV-2 (PASC), which is another name for "Long Covid."

Timeline

Start

2022-11-08

Primary completion

2023-08-14

Completion

2023-09-12

Outcome

Missed primary endpoint

paper no statistically significant difference in the model-derived severity outcome pooled across the 6 core symptoms at 10 weeks between the NMV/r and PBO/r groups. PMID 38848477 ↗

registry analysis (other test); Nirmatrelvir Plus Ritonavir vs Placebo Plus Ritonavir; p = 0.903; NCT05576662 ↗

Publications

• Results Geng LN, Bonilla H, Hedlin H, Jacobson KB, Tian L, Jagannathan P, Yang PC, Subramanian AK, Liang JW, Shen S, Deng Y, Shaw BJ, Botzheim B, Desai M, Pathak D, Jazayeri Y, Thai D, O'Donnell A, Mohaptra S, Leang Z, Reynolds GZM, Brooks EF, Bhatt AS, Shafer RW, Miglis MG, Quach T, Tiwari A, Banerjee A, Lopez RN, De Jesus M, Charnas LR, Utz PJ, Singh U. 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. doi: 10.1001/jamainternmed.2024.2007.
• Results Gunturkun F, Hedlin H, Botzheim B, Deng Y, Bonilla H, Jagannathan P, Quach TC, Kim S, Lin M, O'Riordan G, Tzeng H, Adamowicz L, Demanuele C, Cai X, Yang PC, Singh U, Geng LN. Digital Biometric Measures in Long COVID: A Secondary Analysis of the STOP-PASC Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2526901. doi: 10.1001/jamanetworkopen.2025.26901.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nirmatrelvir	Small molecule	300 mg	Oral
Background	Ritonavir	Other / unclassified	100 mg	Oral

Indications