NHLBI is issuing this Notice of Special Interest (NOSI) due to the urgent need for early phase clinical trials to evaluate new or existing interventions that may prevent or treat Coronavirus Disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). NHLBI seeks to leverage existing clinical trials expertise and, using NHLBI programs that are actively conducting Phase I-III clinical trials, to rapidly initiate and conduct Phase I-Phase I/II (bridging) clinical trials in patients at risk for SARS-CoV-2 infection and/or patients with COVID-19. It is strongly recommended that the parent activity code be one of the following: P01, R01, R33, R41, R42, R43, R44, U01, U24, U54, UH3, or UM1.
Topics of specific interest to the NHLBI include the safety and efficacy of interventions for primary prevention and/or treatment of COVID-19, associated clinical phenotypes, and surrogate outcomes, relevant to heart, lung, and blood (HLB) diseases.
Programs currently conducting research without an active Phase I-III clinical trial may wish to consider applications to NOT-HL-20-757.
Background
Coronaviruses are a diverse family of viruses that cause a range of disease in humans and animals, and there are currently no approved coronavirus vaccines or therapeutics. In January 2020, a novel coronavirus, SARS-CoV-2, was identified as the causative agent of an outbreak of viral pneumonia centered around Wuhan, China. Current information regarding confirmed cases is changing daily and can be found on the Centers for Disease Control and Prevention website (https://www.cdc.gov/coronavirus/index.html).
Patients diagnosed with this illness have reported symptoms such as fever, cough, shortness of breath, fatigue, myalgias, headache, sore throat, abdominal pain, and diarrhea. Patients admitted to the hospital generally have pneumonia and abnormal chest imaging, and complications include acute respiratory failure, acute respiratory distress syndrome (ARDS), and acute myocardial injury. The severity of illness and course of the infection is heterogenous and appears to be more severe in the elderly and in individuals with underlying comorbidities, including cardiovascular and chronic respiratory diseases. Emerging evidence indicates that cytokine storm is associated with severity and early cardiac injury. Additionally, ARDS, thrombocytopenia and disseminated intravascular coagulopathy (DIC) are associated with severity and mortality.