REMAP-CAP

                            

Sites open

Global: 332  UK: 143

Patients randomised (all)

Global: 11,519 UK: 5,666

Patients randomised (COVID-19)

Global: 9,945 UK: 5,539

 

What is this study about?

REMAP-CAP is an international (15 countries) adaptive platform trial in community acquired pneumonia, that was specifically designed to be employed in a pandemic to evaluate multiple interventions simultaneously in critically ill patients. In addition to recruiting patients with community acquired pneumonia who have been admitted to critical care, we are also recruiting patients with COVID-19 to understand optimal treatment strategies.

The trial is modular so that new domains (groups of similar treatment options) can be added over time.

COVID-19 treatment domains:

ICU only

• Statin Two interventions: (1) No statin therapy; (2) Simvastatin

• Anticoagulation 
  • No prior therapeutic anticoagulation - Two interventions: (1) Conventional low dose thromboprophylaxis; (2) Intermediate dose thromboprophylaxis 
  • Prior therapeutic anticoagulation - Three interventions: (1) Conventional low dose thromboprophylaxis; (2) Intermediate dose thromboprophylaxis

• Cysteamine Two interventions: (1) No cysteamine; (2) Cysteamine

ICU and Ward

• Updated Immunoglobulin Two interventions: (1) High titer convalescent plasma; (2) No immunoglobulin

Domains closed/paused to recruitment:

• Corticosteroids (1) Letter to sites 13JUL2020; (2) JAMA publication – Effect of Hydrocortisone on Mortality and Organ Support in Patients with Severe COVID-19; (3) JAMA  publication - Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis

• Antivirals (1) Letter to sites 13JUL2020; (2) Letter to sites 19NOV2020; (3) Nat Commun publication - Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials (4) Letter to sites 09SEP2022

• Immunoglobulin therapy (1) Letter to sites 07JAN2021

• Therapeutic anticoagulation  (1) Letter to sites 19DEC2020; (2) Letter to sites 08JAN2021; (3) Letter to sites 22JAN2021; (4) ATTACC, ACTIV-4a & REMA-CAP Multiplatform RCT: Results of Interim Analysis; (4) Pre-print - Therapeutic Anticoagulation in Critically Ill Patients with Covid-19 – Preliminary Report, The REMAP-CAP, ACTIV-4a, and ATTACC Investigators; (5) Pre-print - Therapeutic Anticoagulation in Non-Critically Ill Patients with Covid-19, The ATTACC, ACTIV-4a, and REMAP-CAP Investigators
  

• Immune modulation (1) Press release 19NOV2020; (2) Letter to sites 07JAN2021; (3) NEJM publication - Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19; (4) Letter to sites 09APR2021; (5) Pre-print - Effectiveness of Tocilizumab, Sarilumab and Anakinra for Critically Ill Patients with Covid-19

• Antiplatelet (1) Letter to sites 23JUN2021; (2) Press release 30JUN2021

• ACE2 RAS (1) Letter to sites 16JUN2022

• Continuation of therapeutic dose anticoagulation (1) Letter to sites 06JUL2022

• Vitamin C (in pandemic stratum) (1) Letter to sites 16JUL2022

Community Acquired Pneumonia treatment domains:

• Antibiotics Five interventions: (1) Ceftriaxone + Macrolide; (2) Moxifloxacin or Levofloxacin; (3) Piperacillin-tazobactam + Macrolide (4) Ceftaroline + Macrolide (5) Amoxicillin-clavulanate + Macrolide

• Macrolide duration Two interventions: (1) Standard course (3-5 days); (2) Extended course (14 days)

• Corticosteroids Three interventions: (1) No steroids; (2) Steroids for 7 days (3) Steroids if shock present

• Antivirals (influenza) Three interventions: (1) No antiviral for influenza; (2) Oseltamivir (5 days); (3) Oseltamivir (10 days)

• Cysteamine Two interventions: (1) No cysteamine; (2) Cysteamine

 

Domains closed/paused to recruitment:

• Vitamin C (in non-pandemic stratum) (1) Letter to sites 17JUN2022

Further information can be found on the global REMAP-CAP website https://www.remapcap.org

COVID-19 Summary of study results (19MAY2021)

Information for sites

Information is available for participating sites on set-up, randomisation, pharmacy arrangements and FAQs.

Chief Medical Officers' letter of support

REMAP-CAP has been named as one of the three national randomised trials in COVID-19. Please find the letter of support encouraging participation of all hospitals into these studies.

Registration 

REMAP-CAP is registered: NCT02735707
EudraCT number: 2015-002340-14

Funding and support