COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04260594

Jieming QU, professor

Not reported

2020-02-07

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: aged 18 to 65 years old (including 18 and 65 years); male and non-pregnant female; respiratory tract specimens or hematology samples detected positive results of sars-cov-2 by real-time transcriptase polymerase chain reaction (rt-pcr). 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.

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.

2

Jieming QU

18

75

China

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

236

Virus negative conversion rate in the first week

None

Phase 4

[{"arm_notes": "", "treatment_id": 1336, "treatment_name": "Umifenovir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]