Timing of corticosteroids in non-severe non-hospitalized COVID-19 patients: open-label, two-center, randomized controlled study (TICS-COV19 study).

"No potential conflict of interest relevant to this article was reported."

"A parallel randomized controlled, open-label was conducted on COVID-19 non-vaccinated patients confirmed to have COVID-19 attending the outpatient clinics of two centers in Cairo, Egypt, from March 2021 to November 2021. COVID-19 was confirmed according to the positive results of SARS-COV-2 nucleotides following the WHO guidelines []. The medical research ethical committee (MREC) of the National Research Center (NRC) approved the study with approval number (011022021). The study has clinicaltrials.gov number NCT04530409. Informed consent was obtained from all participants. The nasopharyngeal or throat swab specimens were collected, and the SARS-COV-2 nucleotides were tested using real-time polymerase chain reaction (RT-PCR). Eligibility criteria required individuals who were 18 years or older, male or female, confirmed COVID-19 clinically, radiologically, and by PCR for RNA SARS-CoV-2 of mild or moderate severity with an elevated inflammatory marker (C-reactive protein [CRP], lactate dehydrogenase [LDH], or ferritin). However, patients with immunodeficiency disorders, receiving anti-cancer/immunosuppressive therapy, patients with confirmed bacterial infection, severe cases requiring immediate intensive care unit admission or on chronic steroid therapy or using CSs after progression to severe disease, refusing to participate, or participating in another study were excluded. We assessed the participants’ severity according to the local COVID-19 protocol: Ministry of Health (MOH) protocol version 1.4 November 2020 as follows: Mild cases (mild symptoms & normal computed tomography [CT] imaging & SpO2 > 92%) and moderate cases (positive CT, SpO2 > 92%) []."