Clinical trial NCT04581018: An Evaluation of a Synbiotic Formula for Patients With COVID-19 Infection
Official title: An Evaluation of a Synbiotic Formula for Symptom Improvement in Hospitalised Patients With COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Microbiota
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In December 2019, a cluster of pneumonia cases of unidentified cause emerged in Wuhan,was identified as the culprit of this disease currently being identified as "Coronavirus Disease 2019" (COVID-19) by World Health Organization.

Coronavirus was found to not only target the patient's lungs but also multiple organs. Around 2-33% of Coronavirus Disease-19 patients developed gastrointestinal symptoms. Studies have shown that Severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) was found in patient's feces, suggesting that the virus can spread through feces. In our previous study, stool samples from 15 patients with COVID-19 were analysed. Depleted symbionts and gut dysbiosis were noted even after patients were detected negative of SARS-CoV-2. A series of microbiota were correlated inversely with the disease severity and virus load. Gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes.

The investigators are uncertain about the impact of synbiotic on patients with COVID-19. However, a therapeutic strategy aiming at investigating the gut Imicrobiota of patients with COVID-9 who take synbiotic or not, leading to lesser progression to severe disease, less hospital stay and improved quality of life.

Detailed description: In December 2019, a cluster of pneumonia cases of unidentified cause emerged in Wuhan, Hubei province, China. In early January, a novel betacoronavirus forming another clade within the subgenus sarbecovirus, now named SARS-CoV-2, was identified as the culprit of this disease currently being identified as "Coronavirus Disease 2019" (COVID-19) by WHO.

Coronavirus was found to not only target the patient's lungs, but also multiple organs. Around 2-33% of COVID-19 patients developed gastrointestinal symptoms. Studies have shown that SAR-CoV-2 was found in patient's feces, suggesting that the virus can spread through feces. In our previous study, stool samples from 15 patients with COVID-19 were analysed. Depleted symbionts and gut dysbiosis were noted even after patients were detected negative of SARS-CoV-2. A series of microbiota were correlated inversely with the disease severity and virus load. Gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes.

In July 2020, there are more than 15 million confirmed cases globally with 620 thousand deaths. Currently, there are more than 2000 confirmed cases of COVID-19 in Hong Kong. The investigators are uncertain about the impact of synbiotic on patients with COVID-19. However, a therapeutic strategy aiming at investigating the gut Imicrobiota of patients with COVID-9 who take synbiotic or not, leading to lesser progression to severe disease, less hospital stay and improved quality of life.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 or above; and
2. A confirmed diagnosis of SARS-CoV-2 infection using the PCR according to the standard of according to Centre for Health Protection, Department of Health, HK at recruitment and that require admission to the hospitalization area; and
3. Written informed consent is obtained

Exclusion Criteria:

1. Subjects admitted to Intensive Care Unit or on ventilator
2. Known allergy or intolerance to the intervention product or its components
3. Any known medical condition that would prevent taking oral probiotics or increase risks associated with probiotics including but not limited to inability to swallow/aspiration risk and no other methods of delivery (e.g no G/J tube)
4. Known increased infection risk due to immunosuppression such as:

   * Prior organ or hematopoietic stem cell transplant
   * Neutropenia (ANC \<500 cells/ul)
   * HIV and CD4 \<200 cells/ul
5. Known history or active endocarditis
6. Recent on CAPD or hemodialysis-
7. Documented pregnancy

Primary outcomes:
measure: Combined symptom score
timeFrame: 4 weeks
Secondary outcomes:
measure: Clinical improvement
timeFrame: 4 weeks
measure: Time to develop antibody against SARS-CoV-2
timeFrame: 16 days
measure: Quality of life measured by EQ-5D-5L
timeFrame: 4 weeks
measure: Quality of life measured by SF-12
timeFrame: 4 weeks
measure: Duration of hospital stay
timeFrame: up to 3 months
measure: Time to negative PCR
timeFrame: through study completion, an average of 1 year
measure: Trend of symptom score
timeFrame: 4 weeks
measure: Gastrointestinal symptoms
timeFrame: 4 weeks
measure: Changes in fecal bacteria metabolites
timeFrame: weeks 2, 4, 5 and 8 months 3, 6, 9 and 12
measure: Change in plasma cytokines level
timeFrame: week 2 and week 5
measure: Changes in the gut microbiome
timeFrame: weeks 1, 2, 3, 4, 5, 8 and months 3, 6, 9 and 12
measure: Number of admission to Intensive Care Unit
timeFrame: 4 weeks
measure: Number of subjects with home discharge
timeFrame: 4 weeks
measure: Number of mortality
timeFrame: 4 weeks
measure: Number of days absent from work
timeFrame: 3 months
measure: Change of quality of life questionnaire
timeFrame: week 8, months 3, 6, 9 and 12
measure: Number of adverse event
timeFrame: 3 months
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Siew Chien Ng
role: PRINCIPAL_INVESTIGATOR
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