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

Abstract

To date no treatment protocol of proven efficacy was approved to manage\nCOVID-19. We have developed a novel COVID-19 immunomodulatory protocol\nbasing on our early pioneering article that justified repurposing of\nnitazoxanide/azithromycin combination for early cases of COVID-19 which\nwas followed by two articles to justify addition of non-steroidal\nanti-inflammatory drugs to nitazoxanide/azithromycin. We are presenting\na prospective telemedicine protocol that managed more than 50 documented\nCOVID-19 patients while fully presenting a case series of 36\npatients/legal guardians COVID-19 Arab patients including 12 confirmed\nby PCR and 23 diagnosed by other measures. The patients included 14\nadult males including an immunocompromised patient, 15 adult females\nincluding one lactating, 3 pregnant patients including one confirmed by\nPCR as well as 4 children. All patients have received a short\n5-day-regimen of NSAIDs (diclofenac potassium in most of cases,\nibuprofen, lornoxicam, meloxicam, celecoxib, naproxen, ketoprofen or\nketorolac)/nitazoxanide/azithromycin +/- cefoperazone either in full or\nin part as illustrated in the manuscript. The primary endpoint of this\nprotocol was full relief of all serious COVID-19 clinical manifestations\nand it was fully achieved in all patients within two weeks. Most of the\npatients treated early have fully recovered during its described five\ndays; the leucocytic/lymphocytic count was significantly improved for\nthose with prior leucopenia/lymphopenia. No significant adverse effects\nwere reported. 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 against any current\nstandard protocol.