The First Hospital of Zibo City, Shandong Province: recruitment of new crown patients, eligible for contact with the hospital

January 3, 2023January 3, 2023

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The Department of Respiratory and Critical Care Medicine at the First Hospital of Zibo is conducting a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of GS221 in patients with mild or common novel coronavirus pneumonia, Protocol No. GS221-2022-001. Patients with mild or common novel coronavirus pneumonia are being recruited for this study, to be conducted at approximately 20 clinical research centers nationwide, with a total of 312 patients expected to be enrolled in Part B.

Primary Study Description.

There will be 2 treatment groups in this trial, and after screening, eligible subjects will be randomized in a 3:1 ratio to receive either 5 days of GS221 treatment or placebo, with each subject receiving the study drug (GS221 or placebo) with warm water, not chewed. Oral doses of 375 mg once daily on the first day and a maintenance dose of 125 mg once daily on the subsequent 4 days for a total of 5 days were followed until confirmation of nucleic acid conversion and complete resolution of clinical symptoms or study day 14.

Patients should contact the institution if they initially meet the following criteria.

18 ≤ age ≤ 70 years.
a diagnosis of neocrown pneumonia in patients with mild and common types.
is positive by nucleic acid testing or antigen testing.
the presence of cough, shortness of breath or dyspnea, fever, chills, fatigue, body aches or muscle pain, diarrhea, nausea, vomiting, headache, sore throat, nasal congestion, runny nose, loss of taste or smell any symptoms associated with New Coronary Pneumonia
negative pregnancy test prior to enrollment for women of childbearing age.
Not participating in other clinical trials within one month.