COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49224

Lunxu Liu

lunxu_liu@aliyun.com

2020-02-08

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Aged over 18 years, 2. Real-time fluorescent RT-PCR for respiratory or blood specimens to detect novel coronavirus nucleic acid positive, 3. The sequence of virus genes in respiratory or blood samples was highly homologous with the known novel coronavirus, 4. A common or severe type of new type of coronavirus pneumonia was diagnosed. The common patients diagnosed with novel coronavirus pneumonia that have fever, respiratory symptoms, and imaging shows pneumonia. Some severe patients could be included. Accord with any of the following: (1) Respiratory distress, RR >= 30 times / minute, (2) In resting state, means oxygen saturation <= 93%, (3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <= 300mmHg.

1. Pregnant or lactating women, 2. Patients who cannot be inhaled by atomization, 3. Patients who are intolerant or allergic to interferon preparations, 4. Other patients were judged unsuitable for inclusion in the trial by researchers.

2

West China Hospital; Sichuan University

18

75

China

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

disease remission;time to clinical improvement;overall rates of clinical improvement assessed at days 7; 14; and 28;time to chest CT improvement; time to virus nucleic acid negative-conversion;overall rates of radiological improvement on days 7; 14; and 28;overall rates of virus nucleic acid negative-conversion on qRT-PCR in nasopharyngeal swabs samples on days 7; 14; and 28;serious adverse events;

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

Phase 0

[{"arm_notes": "", "treatment_id": 664, "treatment_name": "Interferon alpha", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1090, "treatment_name": "Recombinant super-compound interferon (rsifn-co)", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}]