Statistical Analysis Plan for the Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID) Randomized Controlled Trial

  1. Yaseen Arabi
  2. Haytham Tlayjeh
  3. Sara Aldekhyl
  4. Hasan Al-Dorzi
  5. Sheryl Ann Abdukahil
  6. Jesna Jose
  7. Mohammad Khulaif Al Harbi
  8. Husain Al Haji
  9. Mohammed Al Mutairi
  10. Omar Al Zumai
  11. Eman Al Qasim
  12. Wedyan Al Wehaibi
  13. Saad Al Qahtani
  14. Mohammed Alshahrani
  15. Talal Albrahim
  16. Ahmed Mady
  17. Ali Al Bshabshe
  18. Zohair Al Aseri
  19. Zainab Al Duhailib
  20. Ayman Kharaba
  21. Rakan Alqahtani
  22. Haifa Algethamy
  23. Omar Alfaris
  24. Omar Alnafel
  25. Abdulrahman A Al-Fares
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Abstract

Background and objective

Noninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19). Helmet noninvasive ventilation having multiple advantages over other support modalities but data about effectiveness are limited.

Methods

In this multicenter randomized trial of helmet non-invasive ventilation for COVID-19 patients (Helmet-COVID), 320 adult ICU patients with suspected or confirmed COVID-19 and acute hypoxemic respiratory failure (with a ratio of arterial oxygen partial pressure to fraction (percent) of inspired oxygen (PaO2/FiO2) <200 despite supplemental oxygen with a partial/non-rebreathing mask at a flow rate >10 L/min or above) will be randomized to helmet-noninvasive ventilation with usual care or usual care alone. The primary outcome is death from any cause within 28 days after randomization. The trial has 80% power to detect a 15% absolute risk reduction from 40% to 25%.

Conclusion

Consistent with international guidelines, we developed a detailed plan to guide the analysis of the Helmet-COVID trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes to facilitate unbiased analyses of clinical data.

Trial registration

Clinicaltrials.gov: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04477668">NCT04477668</ext-link> (registered on July 20, 2020)

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