TY - JOUR
AU - Harris, Victoria C.
AU - Holmes, Jane
AU - Gbinigie-Thompson, Oghenekome
AU - Rahman, Najib M.
AU - Richards, Duncan B.
AU - Hayward, Gail
AU - Dorward, Jienchi
AU - Lowe, David M.
AU - Standing, Joseph F.
AU - Breuer, Judith
AU - Khoo, Saye
AU - Petrou, Stavros
AU - Hood, Kerenza
AU - Ahmed, Haroon
AU - Carson-Stevens, Andrew
AU - Nguyen-Van-Tam, Jonathan S.
AU - Patel, Mahendra G.
AU - Saville, Benjamin R.
AU - Francis, Nick
AU - Thomas, Nicholas P.B.
AU - Evans, Philip
AU - Dobson, Melissa
AU - Png, May Ee
AU - Lown, Mark
AU - van Hecke, Oliver
AU - Jani, Bhautesh D.
AU - Hart, Nigel D.
AU - Butler, Daniel
AU - Cureton, Lucy
AU - Patil, Meena
AU - Andersson, Monique
AU - Coates, Maria
AU - Bateman, Clare
AU - Davies, Jennifer C.
AU - Raymundo-Wood, Ivy
AU - Ustianowski, Andrew
AU - Yu, Ly-Mee
AU - Hobbs, F.D. Richard
AU - Little, Paul
AU - Butler, Christopher C.
AU - Moftah, Areej
AU - Goodman, Anna L.
AU - Halifax, Rob
AU - Turnbull, Chris D.
AU - Sundaralingam, Anand
AU - Agyeman, Akosua A.
AU - Shah, Divya
AU - Brown, Julianne Rose
AU - Thalasselis, Chris
AU - Woodall, Maximillian N.J.
AU - Yongblah, Francis
AU - Howell, Aleksandra
AU - Patel, Kavil
AU - Hussain, Iqbal
AU - Penfold, Ruth
AU - Hutchinson, Simon
AU - Poonian, Satveer
AU - Imlach, Marie
AU - Popoola, Olajide
AU - Irving, Greg
AU - Pora, Alexander
AU - Jacobsen, Nicholas
AU - Prasad, Vibhore
AU - Kennard, James
AU - Prasad, Rishabh
AU - Khan, Umar F.
AU - Razzaq, Omair
AU - Knox, Kyle
AU - Richardson, Scot
AU - Krasucki, Christopher
AU - Royal, Simon
AU - Law, Tom
AU - Safa, Afsana
AU - Lee, Rem
AU - Sehdev, Satash
AU - Lester, Nicola
AU - Sevenoaks, Tamsin
AU - Lewis, David
AU - Sheikh, Aadil
AU - Lunn, James
AU - Short, Vanessa
AU - Mackintosh, Claire L.
AU - Singh Sidhu, Baljinder
AU - Mathukia, Mehul
AU - Singh, Ivor
AU - Moore, Patrick
AU - Soni, Yusuf
AU - Morton, Seb
AU - Wilson, Pete
AU - Murphy, Daniel
AU - Wingfield, David
AU - Nally, Rhiannon
AU - Wong, Michael
AU - Ndukauba, Chinonso
AU - Wooding, Nick
AU - Ogundapo, Olufunto
AU - Woods, Sharon
AU - Okeke, Henry
AU - Yong, Joanna
AU - Ahmed, Tanveer
AU - Allcock, Damien
AU - Atherton, George
AU - Beltran-Martinez, Adrian
AU - Benedict, Oluseye Emmanuel
AU - Bird, Nigel
AU - Brennan, Laura
AU - Burns, Gerard
AU - Butler, Mike
AU - Butler, Daniel
AU - Carson-Stevens, Andrew
AU - Cheng, Zelda
AU - Danson, Ruth
AU - de Kare-Silver, Nigel
AU - Dhasmana, Devesh
AU - Dickson, Jon
AU - Engamba, Serge
AU - Fisher, Stacey
AU - Fox, Robin
AU - Frost, Eve
AU - Gaunt, Richard
AU - Ghosh, Sarit
AU - Gilkar, Ishtiaq
AU - Goodman, Anna L.
AU - Granier, Steve
AU - Packham, Alice
AU - Dowsell, Sarah
AU - Gulati, Radhika
AU - Patel, Amit
PY - 2024
DA - September
TI - Health outcomes 3 months and 6 months after molnupiravir treatment for COVID-19 for people at higher risk in the community (PANORAMIC): a randomised controlled trial
JO - The Lancet Infectious Diseases
DO - http://dx.doi.org/10.1016/S1473-3099(24)00431-6
AB - Background: No randomised controlled trials have yet reported on the effectiveness of molnupiravir on longer term outcomes for COVID-19. The PANORAMIC trial found molnupiravir reduced time to recovery in acute COVID-19 over 28 days. We aimed to report the effect of molnupiravir treatment for COVID-19 on wellbeing, severe and persistent symptoms, new infections, health care and social service use, medication use, and time off work at 3 months and 6 months post-randomisation. Methods: This study is a follow-up to the main analysis, which was based on the first 28 days of follow-up and has been previously reported. For this multicentre, primary care, open-label, multi-arm, prospective randomised controlled trial conducted in the UK, participants were eligible if aged at least 50 years, or at least 18 years with a comorbidity, and unwell 5 days or less with confirmed COVID-19 in the community. Participants were randomly assigned to the usual care group or molnupiravir group plus usual care (800 mg twice a day for 5 days), which was stratified by age (&lt;50 years or ≥50 years) and vaccination status (at least one dose: yes or no). The primary outcome was hospitalisation or death (or both) at 28 days; all longer term outcomes were considered to be secondary outcomes and included self-reported ratings of wellness (on a scale of 0–10), experiencing any symptom (fever, cough, shortness of breath, fatigue, muscle ache, nausea and vomiting, diarrhoea, loss of smell or taste, headache, dizziness, abdominal pain, and generally feeling unwell) rated as severe (moderately bad or major problem) or persistent, any health and social care use, health-related quality of life (measured by the EQ-5D-5L), time off work or school, new infections, and hospitalisation. Findings: Between Dec 8, 2021, and April 27, 2022, 25 783 participants were randomly assigned to the molnupiravir plus usual care group (n=12 821) or usual care group (n=12 962). Long-term follow-up data were available for 23 008 (89·2%) of 25 784 participants with 11 778 (91·9%) of 12 821 participants in the molnupiravir plus usual care group and 11 230 (86·6%) of 12 963 in the usual care group. 22 806 (99·1%) of 23 008 had at least one previous dose of a SARS-CoV-2 vaccine. Any severe (3 months: adjusted risk difference –1·6% [–2·6% to –0·6%]; probability superiority [p(sup)]&gt;0·99; number needed to treat [NNT] 62·5; 6 months: –1·9% [–2·9% to –0·9%]; p(sup)&gt;0·99, NNT 52·6) or persistent symptoms (3 months: adjusted risk difference –2·1% [–2·9% to –1·5%]; p(sup)&gt;0·99; NNT 47·6; 6 months: –2·5% [–3·3% to –1·6%]; p(sup)&gt;0·99; NNT 40) were reduced in severity, and health-related quality of life (measured by the EQ-5D-5L) improved in the molnupiravir plus usual care group at 3 months and 6 months (3 months: adjusted mean difference 1·08 [0·65 to 1·53]; p(sup)&gt;0·99; 6 months: 1·09 [0·63 to 1·55]; p(sup)&gt;0·99). Ratings of wellness (3 months: adjusted mean difference 0·15 (0·11 to 0·19); p(sup)&gt;0·99; 6 months: 0·12 (0·07 to 0·16); p(sup)&gt;0·99), experiencing any more severe symptom (3 months; adjusted risk difference –1·6% [–2·6% to –0·6%]; p(sup)=0·99; 6 months: –1·9% [–2·9% to –0·9%]; p(sup)&gt;0·99), and health-care use (3 months: adjusted risk difference –1·4% [–2·3% to –0·4%]; p(sup)&gt;0·99; NNT 71·4; 6 months: –0·5% [–1·5% to 0·4%]; p(sup)&gt;0·99; NNT 200) had high probabilities of superiority with molnupiravir treatment. There were significant differences in persistence of any symptom (910 [8·9%] of 10 190 vs 1027 [11%] of 9332, NNT 67) at 6 months, and reported time off work at 3 months (2017 [17·9%] of 11 274 vs 2385 [22·4%] of 10 628) and 6 months (460 [4·4%] of 10 562 vs 527 [5·4%] of 9846; NNT 100). There were no differences in hospitalisations at long-term follow-up. Interpretation: In a vaccinated population, people treated with molnupiravir for acute COVID-19 felt better, experienced fewer and less severe COVID-19 associated symptoms, accessed health care less often, and took less time off work at 6 months. However, the absolute differences in this open-label design are small with high numbers needed to treat.
PB - Elsevier
UR - https://eprints.gla.ac.uk/334774/
KW - Coronavirus (COVID-19)
ER