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Trial - ChiCTR2000030922


Column Value
Trial registration number ChiCTR2000030922
Full text link
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Bin Zhang/Yinong Ye

Contact
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

FSYYN001@126.com

Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-03-17

Recruitment status
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

(1) Aged 18 to 65 years old, (2) Patients with mild or normal type who have been diagnosed with new type of coronavirus infection [in accordance with the diagnostic criteria of the Notice on Printing and Distributing New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Implementation) issued by the National Health and Medical Commission], (3) According to the National Health and Health Commission's antiviral treatment for more than 10 days, the COVID-19 nucleic acid examination of the throat swabs/putum /stool samples was still positive or weakly positive.

Exclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

(1) Female patients who are pregnant or planning to become pregnant within 7 months, (2) ALT is higher than 10 times the upper limit of normal value, or total bilirubin is highter than 2 times the upper limit of normal value, or the stage of decompensation of cirrhosis, or has had decompensation of cirrhosis, (3) The number of peripheral blood leukocytes and/or platelets is lower than the lower limit of normal value, (4) There are serious important organs such as cardiovascular,lung,kidney,brain lesions and fundus lesions, (5) Combined with autoimmune disease,mental illness,diabetes,and abnormal thyroid function (hyperthyroidism or hypothyroidism), (6) Those diagnosed or suspected of malignant tumors, (7) Those who are using immunosuppressive drugs or after organ transplantation or who are preparing to undergo organ transplantation, (8) Drug addicts or people with HIV infection, (9) Those who are allergic to interferon, (10) There are other situations in which interferon is not suitable for use by the doctor in charge, (11) Men who did not take effective contraception during and after the treatment period.

Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Foshan First People's Hospital

Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

65

Countries
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

China

Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mild/moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

30

primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

COVID-19 nucleic acid negative conversion rate;Causal mortality;All-cause mortality;

Notes
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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

Phase
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 2210, "treatment_name": "Interferon alpha 2a+ribavirin", "treatment_type": "Interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1724, "treatment_name": "Interferon alpha+umifenovir", "treatment_type": "Interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}]