REMAP-COVID— Evaluating Multiple Treatments Worldwide

REMAP-COVID is a sub-study of REMAP-CAP (A Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia) and tests multiple interventions for the treatment of patients hospitalized with COVID-19.

REMAP-CAP was developed to test treatments for severe pneumonia both in non-pandemic and pandemic settings. In February 2020, REMAP-CAP rapidly pivoted to its pandemic mode (the REMAP-COVID sub-study), as per its original intent, to incorporate additional potential treatment regimens specifically targeting COVID-19. This trial is a multicenter, randomized platform study, with treatments tested within groupings or “domains” based on clinical action.

REMAP–COVID is open at more than 300 sites across 25 countries and, as of January 2021 has enrolled over 9,000 patients. Through partnerships with academia, industry, and healthcare systems, GCAR is sponsoring REMAP-COVID in the U.S. with the University of Pittsburgh serving as the U.S. Regional Coordinating Center for REMAP-CAP.

THE CHALLENGE

As of October 2022, over 6.5 million have lost their lives to COVID worldwide.

COVID-19 emerged as a public health crisis due to the global spread of SARS-CoV2. Highly contagious through respiratory droplets and with a high mortality rate in vulnerable populations, there is currently the need to develop additional approved therapies for clinicians to treat their patients.

It was critical to rapidly develop and implement a clinical protocol to generate evidence in a well-controlled clinical trial to establish the safety and efficacy of potentially life-saving treatments.

How is REMAP-CAP COVID different from other trials?

MULTIFACTORIAL & RANDOMIZED

The platform is multifactorial: each patient can be randomized to multiple treatments.

FREQUENT INTERIM ANALYSES

Use of frequent interim analyses: a question is concluded as soon as there is sufficient information to support a conclusion. Analyses can occur every week.

INTERVENTION COMPARISONS

It detects superiority, inferiority, or equivalence of interventions within the platform.

FLEXIBILITY TO ADD INTERVENTIONS

Additional interventions are added, as required, based on availability and external evidence.

MULTIPLE TREATMENTS

By assigning patients to ‘recipes’ of treatments, only a few patients receive no active therapy.

INTERNATIONALLY AVAILABLE

Actively enrolling COVID-19 patients in 25 countries.

20 x

SARS-CoV-2 (the COVID-19-causing virus) binds 10-20x more tightly to human cells than SARS-CoV (the virus responsible for SARS)

65 +

The greatest percentage of those who die from COVID-19 are age 65+ and living with a chronic disease

80 %

About 80% of COVID-19 infections are mild or asymptomatic, 15% result in moderate to severe symptoms and 5% are critical