NSAIDs/Nitazoxanide/Azithromycin Immunomodulatory Protocol Used in Adults, Geriatric, Pediatric, Pregnant, and Immunocompromised COVID-19 Patients: A Prospective Observational Study and Case-Series

Abstract

Introduction: COVID-19 management still lacks a protocol of proven\nefficacy and we present a novel COVID-19 immunomodulatory protocol\nbasing on our early pioneering article that justified repurposing\nnitazoxanide/azithromycin combination for early COVID-19 which was\nfollowed by two articles to justify addition of non-steroidal\nanti-inflammatory drugs to nitazoxanide/azithromycin as well as by our\nrecent article that illustrates the potential immunomodulatory\nmechanisms by which all the drugs used in this manuscript might benefit\nCOVID-19 patients.\n Methods: We present a case series of 38 confirmed and highly suspected\nCOVID-19 consented native Arabic speaking patients, including 12\nconfirmed by PCR, and the others diagnosed by other measures who were\nmanaged by telemedicine. The patients included 15 adult males including\nan immunocompromised patient, 16 adult females including one lactating,\n3 pregnant patients including one confirmed by PCR as well as 4\nchildren. All patients have received a short 5-day-regimen of NSAIDs /\nnitazoxanide/ azithromycin +/- cefoperazone either in full or in part.\nThe primary endpoint of this protocol was a full relief of all serious\nCOVID-19 clinical manifestations.\n Results: The primary endpoint was fully achieved within two weeks. Most\nof the patients who were treated early, have fully recovered during its\ndescribed five days; the leucocytic/lymphocytic count was significantly\nimproved for those with prior leucopenia or leucocytosis/lymphopenia.\nNeither significant adverse effects, nor post/para COVID syndrome was\nreported.\n Conclusions: a novel 5-day-protocol to safely and effectively cure\nCOVID-19 using repurposed immunomodulatory safe and inexpensive FDA\napproved drugs is illustrated and we recommend performing sufficiently\npowered double-blind randomized clinical trials.