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A Randomized, Double-blind, Placebo-controlled trial for determination of the Efficacy and Safety of Baicalein in Hospitalized Adult Mild and Moderate Patients of novel coronavirus pneumonia (COVID-19)

A Randomized, Double-blind, Placebo-controlled trial for determination of the Efficacy and Safety of Baicalein in Hospitalized Adult Mild and Moderate Patients of novel coronavirus pneumonia (COVID-19)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033286
Enrollment
Unknown
Registered
2020-05-26
Start date
2020-02-15
Completion date
Unknown
Last updated
2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Experimental Group:Baicoli chewable tablets, 200mg / tablet, dosage 200mg / Time, 3 times a day, total 600mg / day, total course of treatment: 10 days
Control Group:Placebo 200 mg / day, 3 times a day, 600 mg / day, for 10 days

Sponsors

Xiangyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults (defined as those aged >=18 years) ; 2. The CT findings of patients with novel coronavirus infection or pneumonia confirmed by PCR; 3. In-patients, accompanied by fever (Temperature at Armpit > 37 degree C) or cough, dyspnea; 4. The interval between symptom onset and randomization was less than 8 days; 5. Agree to participate in the study and accept the randomization; 6. Who has not participated in a drug clinical trial within 3 months prior to signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The physician determines that participation in the study is not in the patient's interest, or in any other case that does not allow the program to proceed safely; 2. Severe liver disease, underlying cirrhosis or a five-fold increase in Alanine transaminase Aspartate transaminase; 3. Severe impairment of Renal Function (estimated glomerular filtration rate <=30 ml / min / 1.73 m2) or continuous renal repair, hemodialysis, peritoneal dialysis; 4. SPO2<=93% , or oxygenation index less than 300 MMHG; 5. Known Allergy or hypersensitivity to Bacoli; 6. Pregnancy: Women of child-bearing age who test positive for pregnancy or breast-feeding; 7. Patients may be transferred to a non-participating hospital within 72 hours. 8.Non-signed informed consent; 9.patients who have used Baicalein or other 2019-nCoV experimental treatment (including compassionate use or trial-related) within 30 days of the induction assessment.

Design outcomes

Primary

MeasureTime frame
time to recovery;

Secondary

MeasureTime frame
Treatment-to-fever time (for patients with fever at admission);Time between treatment and remission of cough (patients with moderate to severe cough when admitted);Time from treatment to dyspnea relief (defined as mild or no dyspnea, applicable to patients with moderate dyspnea at admission);14-day supplemental oxygen therapy or non-invasive mechanical ventilation rate;Treatment to upper respiratory tract specimen 2019-nCoV negative time detected by RT-PCR;14-day all-cause mortality;Incidence of aspiration failure at 14 days (defined as SPO2<=90% or PAO2 / FIO2 < 300 mmHg Without Oxygen Therapy or higher respiratory support);14-day ICU occupancy rate;14-day rate of SAE;

Countries

China

Contacts

Public ContactXiansheng Zeng

Xiangyang General Hospital

310355055@qq.com+86 0710-3516703

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026