PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway

Summary

The goal of this clinical trial is to compare treatment with oral Paxlovid (nirmatrelvir/ritonavir) and placebo for acute COVID-19 as an intervention to prevent long-COVID (post-COVID-19 condition) in adults aged 18-64 years old. The main question it aims to answer is: Does treatment with Paxlovid for acute COVID-19 reduce the prevalence of long-COVID compared to placebo. Participants with acute COVID-19, documented with positive lateral flow test or PCR, within the last 5 days will be randomised to take either Paxlovid or placebo. All participants will receive standard of care in addition. Participants will respond to electronic questionnaires at 14 time points during follow-up. The primary outcome is presence of long-COVID symptoms at 3 months follow-up. Researchers will compare participants who received Paxlovid and placebo to see if Paxlovid treatment can prevent the occurrence of long-COVID.

Timeline

Start

2023-05-12

Primary completion

2025-09-09

Completion

2027-06-11

Publications

• Background Blomberg B, Cox RJ, Langeland N. Long COVID: A growing problem in need of intervention. Cell Rep Med. 2022 Feb 14;3(3):100552. doi: 10.1016/j.xcrm.2022.100552. eCollection 2022 Mar 15.
• Background Blomberg B, Mohn KG, Brokstad KA, Zhou F, Linchausen DW, Hansen BA, Lartey S, Onyango TB, Kuwelker K, Saevik M, Bartsch H, Tondel C, Kittang BR; Bergen COVID-19 Research Group; Cox RJ, Langeland N. Long COVID in a prospective cohort of home-isolated patients. Nat Med. 2021 Sep;27(9):1607-1613. doi: 10.1038/s41591-021-01433-3. Epub 2021 Jun 23.
• Background Fjelltveit EB, Blomberg B, Kuwelker K, Zhou F, Onyango TB, Brokstad KA, Elyanow R, Kaplan IM, Tondel C, Mohn KGI, Ozgumus T, Cox RJ, Langeland N; Bergen COVID-19 Research Group. Symptom Burden and Immune Dynamics 6 to 18 Months Following Mild Severe Acute Respiratory Syndrome Coronavirus 2 Infection (SARS-CoV-2): A Case-control Study. Clin Infect Dis. 2023 Feb 8;76(3):e60-e70. doi: 10.1093/cid/ciac655.
• Background Hippisley-Cox J, Coupland CA, Mehta N, Keogh RH, Diaz-Ordaz K, Khunti K, Lyons RA, Kee F, Sheikh A, Rahman S, Valabhji J, Harrison EM, Sellen P, Haq N, Semple MG, Johnson PWM, Hayward A, Nguyen-Van-Tam JS. Risk prediction of covid-19 related death and hospital admission in adults after covid-19 vaccination: national prospective cohort study. BMJ. 2021 Sep 17;374:n2244. doi: 10.1136/bmj.n2244.
• Background Stokel-Walker C. The search for antivirals for covid-19. BMJ. 2021 Sep 20;374:n2165. doi: 10.1136/bmj.n2165. No abstract available.
• Background Kim PS, Read SW, Fauci AS. Therapy for Early COVID-19: A Critical Need. JAMA. 2020 Dec 1;324(21):2149-2150. doi: 10.1001/jama.2020.22813. No abstract available.
• Background Cevik M, Tate M, Lloyd O, Maraolo AE, Schafers J, Ho A. SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis. Lancet Microbe. 2021 Jan;2(1):e13-e22. doi: 10.1016/S2666-5247(20)30172-5. Epub 2020 Nov 19.
• Background Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16.
• Background Gastine S, Pang J, Boshier FAT, Carter SJ, Lonsdale DO, Cortina-Borja M, Hung IFN, Breuer J, Kloprogge F, Standing JF. Systematic Review and Patient-Level Meta-Analysis of SARS-CoV-2 Viral Dynamics to Model Response to Antiviral Therapies. Clin Pharmacol Ther. 2021 Aug;110(2):321-333. doi: 10.1002/cpt.2223. Epub 2021 May 1.
• Background Laouenan C, Guedj J, Mentre F. Clinical trial simulation to evaluate power to compare the antiviral effectiveness of two hepatitis C protease inhibitors using nonlinear mixed effect models: a viral kinetic approach. BMC Med Res Methodol. 2013 Apr 25;13:60. doi: 10.1186/1471-2288-13-60.
• Background Ertesvag NU, Iversen A, Blomberg B, Ozgumus T, Rijal P, Fjelltveit EB, Cox RJ, Langeland N; Bergen COVID-19 research group. Post COVID-19 condition after delta infection and omicron reinfection in children and adolescents. EBioMedicine. 2023 Jun;92:104599. doi: 10.1016/j.ebiom.2023.104599. Epub 2023 May 5.
• Oppegaard O, Blomberg B, Cox RJ, Iversen A, Myklebust NN, Glambek M, Tondel C, Dahl TB, Friis T, Mjos E, Lehmann ME, Sandvig A, Devold V, Wilhelmsen M, Troseid M, Lie RT, Aukrust P, Langeland N; PANORAMIC Norway Working Group. Nirmatrelvir for acute COVID-19 to prevent long COVID (PANORAMIC Norway): a double-blind, randomised, placebo-controlled trial. Lancet Infect Dis. 2026 Jul 16:S1473-3099(26)00244-6. doi: 10.1016/S1473-3099(26)00244-6. Online ahead of print.
• Blomberg B, Myklebust NN, Oppegaard O, Tondel C, Cox RJ, Iversen A, Lehmann ME, Sandvig A, Dahl TB, Valderhaug VD, Szodoray P, Wilhelmsen M, Kirsebom BE, Glambek M, Kaarboe O, Aukrust P, Lie RT, Langeland N. Randomized trial of nirmatrelvir/ritonavir versus placebo for adults with acute COVID-19 to prevent long COVID: PanoramicNOR Trial. Trials. 2025 Nov 6;26(1):477. doi: 10.1186/s13063-025-09226-6.

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