Title: 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 efficacy and we present a novel COVID-19 immunomodulatory protocol basing on our early pioneering article that justified repurposing nitazoxanide/azithromycin combination for early COVID-19 which was followed by two articles to justify addition of non-steroidal anti-inflammatory drugs to nitazoxanide/azithromycin as well as by our recent article that illustrates the potential immunomodulatory mechanisms by which all the drugs used in this manuscript might benefit COVID-19 patients. Methods: We present a case series of 38 confirmed and highly suspected COVID-19 consented native Arabic speaking patients, including 12 confirmed by PCR, and the others diagnosed by other measures who were managed by telemedicine. The patients included 15 adult males including an immunocompromised patient, 16 adult females including one lactating, 3 pregnant patients including one confirmed by PCR as well as 4 children. All patients have received a short 5-day-regimen of NSAIDs / nitazoxanide/ azithromycin +/- cefoperazone either in full or in part. The primary endpoint of this protocol was a full relief of all serious COVID-19 clinical manifestations. Results: The primary endpoint was fully achieved within two weeks. Most of the patients who were treated early, have fully recovered during its described five days; the leucocytic/lymphocytic count was significantly improved for those with prior leucopenia or leucocytosis/lymphopenia. Neither significant adverse effects, nor post/para COVID syndrome was reported. Conclusions: a novel 5-day-protocol to safely and effectively cure COVID-19 using repurposed immunomodulatory safe and inexpensive FDA approved drugs is illustrated and we recommend performing sufficiently powered double-blind randomized clinical trials.