Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT04260594
Eligibility Criteria:
Inclusion Criteria:
1. aged 18 to 65 years old (including 18 and 65 years);
2. male and non-pregnant female;
3. respiratory tract specimens or hematology samples detected positive results of SARS-CoV-2 by real-time transcriptase polymerase chain reaction (RT-PCR).
4. mild clinical status, defined as having mild clinical symptoms but no signs of pneumonia on imaging or moderate clinical status, defined as having fever, respiratory symptoms and pneumonia on imaging or severe clinical status, defined as having an oxygen saturation (SaO2) of 93% or less at ambient air or a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at or below 400 mgHg, which can be rectified by oxygen inhalation through nasal catheter or face mask.
Exclusion Criteria:
included a physician decision that involvement in the trial was not in the patient's best interest, known allergic reaction and / or severe allergic to arbidol, blood system dysfunction (platelet count \<100×109/L, hemoglobin level \<90g/L), severe liver dysfunction (total bilirubin level \>2 times the normal upper limit, aspartic aminotransferase and alanine aminotransferase levels \>3 times normal upper limit),severe renal dysfunction (serum creatinine \>1.5 times the upper limit of normal value, calculated creatinine clearance rate \<50 ml/min), treated with arbidol before admission, history of severe heart disease or clinically significant arrhythmia considered unsafe for the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04260594
Study Brief:
Protocol Section:
NCT04260594