COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=48809

Gong Guozhong

gongguozhong@csu.edu.cn

2020-02-03

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

(1) aged 18 to 70 years, (2) Light and heavy patients with new coronavirus infection confirmed by etiology.

(1) any situation in which the program cannot proceed safely, (2) allergic constitution, (3) serious basic diseases affecting survival, including uncontrolled malignant tumors with multiple metastases that cannot be resected, blood diseases, malignant fluid, active bleeding, severe malnutrition, HIV, etc., The main organ function is abnormal (4) liver function was obviously abnormal: ALT/AST increased by more than 5 times the normal upper limit, increase of total bilirubin more than 2 times of normal upper limit, (5) obstructive pneumonia, severe pulmonary fibrosis, alveolar proteinosis and allergic alveolitis caused by lung tumors, (6) pregnancy: positive pregnancy test for women of child-bearing age, (7) the patient may be transferred to a non-participating hospital within 72h, (8) continuous use of immunosuppressants or organ transplants within the past 6 months, (9) in vitro life support patients (ECMO, ECCO2R, RRT), (10) expected survival no more than 48 hours.

3

The First Hospital of Changsha; The Second Xiangya Hospital of Central South University

18

70

China

No restriction on type of patients

0: No restriction on type of patients

90

novel coronavirus nucleic acid clearance rate;

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 4

[{"arm_notes": "", "treatment_id": 667, "treatment_name": "Interferon alpha2b", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1611, "treatment_name": "Interferon alpha2b+lopinavir+ritonavir", "treatment_type": "Interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}]