Study design
mild-moderate disease
GROUP B
This phase 2 study was a randomized, placebo-controlled open clinical trial conducted in México City from January to August 2022 by SPV TIMSER company, when the main circulating SARS-CoV-2 variant in México was Omicron (Using G*Power software version 3.1.9.7, a minimum sample size of 20 patients per group was determined with an α of 0.05. Sixty-five COVID-19 positive subjects were recruited and randomized into the following 3 treatment groups: Group A received dose A of 30/2 mg GA/18β (n=20); Group B received dose B of 90/4 mg GA/18β (n=22); and the control group received 0.9% saline solution (n=23).COVID‐19 positive status was confirmed through PCR testing, with enrolled patients exhibiting mild-moderate disease severity in accordance with the World Health Organization’s Clinical Guide for COVID-19 treatment (2021) (Schematic of the trial design. D0-D30 indicates sample collection days.