COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49321

Dong Liang

dl5506@126.com

2020-02-18

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Patients or his/her legal representatives agreed to participate the study and signed the informed consent. 2. Those diagnosed with mild or moderate novel coronavirus pneumonia (NCP) or those with severe NCP but can take medicines orally or via stomach tube. The confirmed patients were defined as those NCP suspects with one of the following pathogenic evidences: 1) The novel coronavirus in respiratory or blood specimens were confirmed by real time RT-PCR. 2) The genetic sequence of the virus detected in respiratory or blood specimen are highly homologous with the known coronavirus, 3. Adult patient aged>=18 years, 4. Those who are able to communicate well with investigators and to complete the study according to the protocol.

1. The serious NCP patients who can neither swallow medicines nor take medicine via stomach tube, and the critical serious NCP patients, 2. Those with severe hypo-immunity due to, but not limited to, one of the following reasons: 1) HIV/AIDS, the condition is still unstable in the process of mediation and /or the last detection value of CD4 plus T lymphocyte is less than 200, 2) Those who received organ transplantation and are given systematic immune treatment, 3) Long-term systematic administration of corticosteroids is defined as daily intake of over 40 mg of Prednisone or equivalent in 14 days before the first medication, 4. Patients who are unable to take medicines orally or via stomach tube, 5. Patients who are allergic to the test medicines, 6. Those with poor communication skills, understanding, cooperation or compliance and those cannot follow protocol to complete the study, 7. Those suffered with serious diseases such as malignancy, mental diseases and so on, or those ineligible to participate the study according to investigators judgement.

2

Qingdao East Sea Pharmaceutical Co.; Ltd.

18

None

China

No restriction on type of patients

0: No restriction on type of patients

300

Time to Clinical recovery;Butyrate in feces;

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

Phase 0

[{"arm_notes": "", "treatment_id": 1022, "treatment_name": "Probiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]