Update on 2019_nCoV, part 5

All quiet at the 2019_nCoV outbreak front, today (so far), it seems. As the world is now informed about the R_0 concept, we can start thinking how to best provide medical care to patients. The evidence base is empty and needs to be filled, preferably with unbiased estimates from randomized studies. Yet, if we had to define research questions now, and then start looking for partners and then draft a protocol, find funding and wait for IRB approval, the first patient-in might coincide with the last patient affected by the virus. So, for pandemic research you better be PREPARED.

The Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) is an ”EU funded network for harmonized large-scale clinical research studies on infectious diseases (IDs), prepared to rapidly respond to any severe ID outbreak, providing real-time evidence for clinical management of patients and for informing public health responses.” The trick for better preparedness is to have ongoing large-scale studies in many different EU regions, that can capture a pandemic whenever it starts.

For this we started almost 6 years ago with what is now called “A Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP).” This is a perpetual European adaptive RCT evaluating the effectiveness of several interventions (antibiotics, corticosteroids) in improving outcome in adults admitted to ICU with severe CAP, see and here.

The study design allows addition of study domains, such as for instance diagnostic testing or new treatments, embedded in the existing study protocol. Only a “simple” amendment is required as IRBs already approved the possibility of such adaptations, in case of a pandemic.

REMAP-CAP is enrolling patients in 52 centres in 13 countries in Europe, Australia/New Zeeland and North-America and more ICUs are ready to start. The study team is discussing – on a daily basis – what interventions to add. Corticosteroids and macrolide use for immunomodulation are already included.

Any studies in China? Yes, 2 protocols posted. “A randomized, open-label, blank-controlled trial for the efficacy and safety of lopinavir-ritonavir and interferon-alpha 2b in hospitalization patients with novel coronavirus infection”, see. The comparator is standard care and the target is 160 patients. The other is “a prospective comparative study for Xue-Bi-Jing injection in the treatment of pneumonia cause by novel coronavirus infection”, see. Xue-Bi-Jing is Chinese herbal medication, which will be compared to standard of care, and here the target is 200 patients per study arm. Rumor has it that recruitment has already been completed.

Any news on R_0 today? Not much. A new publication was embraced as good news, as it showed a dramatic reduction of R_0 in time. Indeed, it started with 8 on December 29th and then rapidly declined to a steady 2.5-3 from Januari 2nd till 18th……2019_nCoV.

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