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Long-term (180-Day) Outcomes in Critically Ill Patients With COVID-19 in the REMAP-CAP Randomized Clinical Trial.
Higgins, Alisa M; Berry, Lindsay R; Lorenzi, Elizabeth; Murthy, Srinivas; McQuilten, Zoe; Mouncey, Paul R; Al-Beidh, Farah; Annane, Djillali; Arabi, Yaseen M; Beane, Abi; van Bentum-Puijk, Wilma; Bhimani, Zahra; Bonten, Marc J M; Bradbury, Charlotte A; Brunkhorst, Frank M; Burrell, Aidan; Buzgau, Adrian; Buxton, Meredith; Charles, Walton N; Cove, Matthew; Detry, Michelle A; Estcourt, Lise J; Fagbodun, Elizabeth O; Fitzgerald, Mark; Girard, Timothy D; Goligher, Ewan C; Goossens, Herman; Haniffa, Rashan; Hills, Thomas; Horvat, Christopher M; Huang, David T; Ichihara, Nao; Lamontagne, Francois; Marshall, John C; McAuley, Daniel F; McGlothlin, Anna; McGuinness, Shay P; McVerry, Bryan J; Neal, Matthew D; Nichol, Alistair D; Parke, Rachael L; Parker, Jane C; Parry-Billings, Karen; Peters, Sam E C; Reyes, Luis F; Rowan, Kathryn M; Saito, Hiroki; Santos, Marlene S; Saunders, Christina T; Serpa-Neto, Ary.
  • Higgins AM; Monash University, Melbourne, Victoria, Australia.
  • Berry LR; Berry Consultants, Austin, Texas.
  • Lorenzi E; Berry Consultants, Austin, Texas.
  • Murthy S; University of British Columbia, Vancouver, British Columbia, Canada.
  • McQuilten Z; Monash University, Melbourne, Victoria, Australia.
  • Mouncey PR; Monash Health, Melbourne, Victoria, Australia.
  • Al-Beidh F; Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.
  • Annane D; Imperial College London, London, United Kingdom.
  • Arabi YM; Hospital Raymond Poincaré (Assistance Publique Hôpitaux de Paris), Garches, France.
  • Beane A; Université Versailles SQY - Université Paris Saclay, Montigny-le-Bretonneux, France.
  • van Bentum-Puijk W; King Saud bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
  • Bhimani Z; University of Oxford, Oxford, United Kingdom.
  • Bonten MJM; University Medical Center Utrecht, Utrecht, the Netherlands.
  • Bradbury CA; St Michael's Hospital Unity Health, Toronto, Ontario, Canada.
  • Brunkhorst FM; University Medical Center Utrecht, Utrecht, the Netherlands.
  • Burrell A; University of Bristol, Bristol, United Kingdom.
  • Buzgau A; Jena University Hospital, Jena, Germany.
  • Buxton M; Monash University, Melbourne, Victoria, Australia.
  • Charles WN; Monash University, Melbourne, Victoria, Australia.
  • Cove M; Global Coalition for Adaptive Research.
  • Detry MA; Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.
  • Estcourt LJ; Yong Loo Lin Scholle of Medicine, National University Singapore, Singapore.
  • Fagbodun EO; Berry Consultants, Austin, Texas.
  • Fitzgerald M; NHS Blood and Transplant, Oxford, United Kingdom.
  • Girard TD; Imperial College London, London, United Kingdom.
  • Goligher EC; Berry Consultants, Austin, Texas.
  • Goossens H; University of Pittsburgh, Pittsburgh, Pennsylvania.
  • Haniffa R; Peter Munk Cardiac Centre at University Health Network, Toronto, Ontario, Canada.
  • Hills T; University of Toronto, Toronto, Ontario, Canada.
  • Horvat CM; University of Antwerp, Antwerp, Belgium.
  • Huang DT; University of Oxford, Bangkok, Thailand.
  • Ichihara N; National Intensive Care Surveillance (NICST), Colombo, Sri Lanka.
  • Lamontagne F; Medical Research Institute of New Zealand (MRINZ), Wellington, New Zealand.
  • Marshall JC; UPMC Children's Hospital of Pittsburg, Pittsburg, Pennsylvania.
  • McAuley DF; University of Pittsburgh, Pittsburgh, Pennsylvania.
  • McGlothlin A; University of Tokyo, Tokyo, Japan.
  • McGuinness SP; Université de Sherbrooke, Sherbrooke, Québec, Canada.
  • McVerry BJ; St Michael's Hospital Unity Health, Toronto, Ontario, Canada.
  • Neal MD; Queen's University Belfast, Belfast, Northern Ireland.
  • Nichol AD; Royal Victoria Hospital, Belfast, Northern Ireland.
  • Parke RL; Berry Consultants, Austin, Texas.
  • Parker JC; Monash University, Melbourne, Victoria, Australia.
  • Parry-Billings K; Auckland City Hospital, Auckland, New Zealand.
  • Peters SEC; University of Pittsburgh, Pittsburgh, Pennsylvania.
  • Reyes LF; University of Pittsburgh, Pittsburgh, Pennsylvania.
  • Rowan KM; Monash University, Melbourne, Victoria, Australia.
  • Saito H; University College Dublin, Dublin, Ireland.
  • Santos MS; Auckland City Hospital, Auckland, New Zealand.
  • Saunders CT; University of Auckland, Auckland, New Zealand.
  • Serpa-Neto A; Monash University, Melbourne, Victoria, Australia.
JAMA ; 329(1): 39-51, 2023 01 03.
Article in English | MEDLINE | ID: covidwho-2287001
ABSTRACT
Importance The longer-term effects of therapies for the treatment of critically ill patients with COVID-19 are unknown.

Objective:

To determine the effect of multiple interventions for critically ill adults with COVID-19 on longer-term outcomes. Design, Setting, and

Participants:

Prespecified secondary analysis of an ongoing adaptive platform trial (REMAP-CAP) testing interventions within multiple therapeutic domains in which 4869 critically ill adult patients with COVID-19 were enrolled between March 9, 2020, and June 22, 2021, from 197 sites in 14 countries. The final 180-day follow-up was completed on March 2, 2022.

Interventions:

Patients were randomized to receive 1 or more interventions within 6 treatment domains immune modulators (n = 2274), convalescent plasma (n = 2011), antiplatelet therapy (n = 1557), anticoagulation (n = 1033), antivirals (n = 726), and corticosteroids (n = 401). Main Outcomes and

Measures:

The main outcome was survival through day 180, analyzed using a bayesian piecewise exponential model. A hazard ratio (HR) less than 1 represented improved survival (superiority), while an HR greater than 1 represented worsened survival (harm); futility was represented by a relative improvement less than 20% in outcome, shown by an HR greater than 0.83.

Results:

Among 4869 randomized patients (mean age, 59.3 years; 1537 [32.1%] women), 4107 (84.3%) had known vital status and 2590 (63.1%) were alive at day 180. IL-6 receptor antagonists had a greater than 99.9% probability of improving 6-month survival (adjusted HR, 0.74 [95% credible interval {CrI}, 0.61-0.90]) and antiplatelet agents had a 95% probability of improving 6-month survival (adjusted HR, 0.85 [95% CrI, 0.71-1.03]) compared with the control, while the probability of trial-defined statistical futility (HR >0.83) was high for therapeutic anticoagulation (99.9%; HR, 1.13 [95% CrI, 0.93-1.42]), convalescent plasma (99.2%; HR, 0.99 [95% CrI, 0.86-1.14]), and lopinavir-ritonavir (96.6%; HR, 1.06 [95% CrI, 0.82-1.38]) and the probabilities of harm from hydroxychloroquine (96.9%; HR, 1.51 [95% CrI, 0.98-2.29]) and the combination of lopinavir-ritonavir and hydroxychloroquine (96.8%; HR, 1.61 [95% CrI, 0.97-2.67]) were high. The corticosteroid domain was stopped early prior to reaching a predefined statistical trigger; there was a 57.1% to 61.6% probability of improving 6-month survival across varying hydrocortisone dosing strategies. Conclusions and Relevance Among critically ill patients with COVID-19 randomized to receive 1 or more therapeutic interventions, treatment with an IL-6 receptor antagonist had a greater than 99.9% probability of improved 180-day mortality compared with patients randomized to the control, and treatment with an antiplatelet had a 95.0% probability of improved 180-day mortality compared with patients randomized to the control. Overall, when considered with previously reported short-term results, the findings indicate that initial in-hospital treatment effects were consistent for most therapies through 6 months.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: JAMA Year: 2023 Document Type: Article Affiliation country: Jama.2022.23257

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: JAMA Year: 2023 Document Type: Article Affiliation country: Jama.2022.23257