The protocol aims to improve standard of care, by ensuring an agile research infrastructure, with an ability to rapidly assess interventions during epidemic transmission of one or more respiratory pathogens adversely affecting public health.
Trials within this protocol can be adaptive, will be randomized, and will have superiority as the primary objective. Comparisons in the trials may be between an unlicensed agent to a blinded placebo plus standard of care (SOC), between an approved off-label agent to a blinded placebo plus SOC, among several active interventions (blinded or non-blinded; i.e., a comparative effectiveness study), or among different treatment strategies.
The purpose of this double-blind, randomized, study is to obtain information on the safety and impact on respiratory function of 150 ppm nitric oxide (NO), given in addition to the standard of care of patients with viral community-acquired pneumonia. The trial is comprised of a treatment period of up to 7 days and follow-up to 180 days post-baseline. Subjects will be randomized 1:1 to receive Treatment or Control. Inhalation treatments will be delivered using LungFit® PRO every 4.5 hours (±30 min). The treatment schedule must be stopped during the night for a recess of at least 7 hours (but not more than 12 hours) in order to ensure the subject's well-being and time to sleep (preferably between 24:00-7:00). This recess will not affect the number of inhalations given in a 24-hour period (4 inhalations in 24 hours).