A prospective, multicenter, open-label, randomized, parallel-controlled trial for probiotics to evaluate efficacy and safety in patients infected with 2019 novel coronavirus pneumonia (COVID-19)

• Register: ChiCTR
• Last refreshed on: 25 February 2020
• Main ID: ChiCTR2000029974
• Date of registration: 2020-02-18
• Prospective Registration: No
• Primary sponsor: Qingdao East Sea Pharmaceutical Co., Ltd.
• Public title: A prospective, multicenter, open-label, randomized, parallel-controlled trial for probiotics to evaluate efficacy and safety in patients infected with 2019 novel coronavirus pneumonia (COVID-19)
• Scientific title: A prospective, multicenter, open-label, randomized, parallel-controlled trial for probiotics to evaluate efficacy and safety in patients infected with 2019 novel coronavirus pneumonia (COVID-19)
• Date of first enrolment: 2020-02-09
• Target sample size: Experimental group:150;Control group:150;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=49321
• Study type: Interventional study
• Study design: Parallel
• Phase: 0

Countries of recruitment

China

Contacts

• Name: CHEN Ying
• Affiliation: Qingdao East Sea Pharmaceutical Co., Ltd.

• Name: Dong Liang
• Affiliation: Qilu Hospital of Shandong University

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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.

Age minimum: 18
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Novel Coronavirus Pneumonia (COVID-19)

Intervention(s)

Experimental group:atic treatment medicines;Control group:Symptomatic treatment medicines;

Primary Outcome(s)

Time to Clinical recovery;Butyrate in feces;

Secondary Outcome(s)

Improvement of gastrointestinal symptoms;Secondary bacterial infection rate;Improvement of chest CT;All cause mortality;Frequency of respiratory progression;Time to defervescence (in those with fever at enrolment);Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate);Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnoea at enrolment rated as severe or moderate);Frequency of requirement for supplemental oxygen or non-invasive ventilation;Frequency of requirement for mechanical ventilation;Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen;Fecal flora;

Source(s) of Monetary Support

Health Commission of Shandong Province, Department of science and technology of Shandong Province, Qingdao East Sea Pharmaceutical Co., Ltd.

Ethics review

Status: Approved
Approval date: 09/02/2020
Contact:

WANG Tong