COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49532

Pei Guangzhong

503818505@qq.com

2020-02-15

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

(1) aged >=18 years old, (2) real-time fluorescence rt-pcr of respiratory or blood samples presents the positive nucleic acid of COVID-19, or the viral gene sequencing of respiratory or blood samples was highly homologous with the known COVID-19. (3) patients diagnosed with novel coronavirus meet the diagnostic criteria of the latest clinical guidelines for novel coronavirus issued by the world health organization (WHO) on January 28, 2020 and the diagnostic criteria of the pneumonia diagnosis and treatment program for novel coronavirus infection (trial version 5) issued by National Health commission of the People's Republic of China.

(1) known or suspected allergy to the components of Azivudine tablets, (2) patients with malabsorption syndrome or any other condition that affects gastrointestinal absorption and requires intravenous nutrition or unable to take oral medication, (3) patients who is currently receiving anti-hiv treatment, (4) patients with one of the following conditions: respiratory failure and mechanical ventilation,Shock,Combined with other organ failure, intensive care unit(ICU) was needed. (5) women who are pregnant or breast-feeding or have a family planning plan during the trial period and within 6 months after the end of the trial, (6) participating in another clinical trials or using experimental drugs within 12 weeks prior to administration, (7) there are other conditions that are not suitable for participating in this experiment evaluated by the investigator.

2

People's Hospital of Guangshan County

18

None

China

No restriction on type of patients

0: No restriction on type of patients

20

time and rate of temperature return to normal;;time and rate of improvement of respiratory symptoms and signs (lung rhones; cough; sputum; sore throat; etc.);time and rate of improvement of diarrhea; myalgia; fatigue and other symptoms;time and rate of pulmonary imaging improvement;time and rate of change to negative COVID-19 nucleic acid test;time and rate of improvement of oxygenation measurement;improvement time and rate of CD4 count;rate of mild/modorate type to severe type; rate of severe type to critical type;length of hospitalization;mortality;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 0

[{"arm_notes": "", "treatment_id": 167, "treatment_name": "Azvudine", "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"}]