COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04399252

Anthony Sung, MD

Lauren Bohannon, lauren.bohannon@duke.edu (PI email not reported)

2020-05-22

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: - age >=1 year (as children <1 year may not be able to take oral probiotics) - household contact of someone diagnosed with covid-19 - willingness to stop taking other probiotics or to not take any other probiotic while on lgg/placebo (taking a probiotic at the time of screening will not be considered a reason for exclusion. however, subjects will be asked to stop taking their probiotic if they enroll on the study). - access to e-mail/internet to complete electronic consent via redcap

symptoms of covid-19 at enrollment, including: fever respiratory symptoms gi symptoms anosmia ageusia ->7 days since original patient associated with household contact was diagnosed with covid-19 taking hydroxychloroquine or remdesivir for any reason (as this would have the potential to decrease the expected rate of covid-19 in this population and affect our power and sample size calculations) enrolled in a covid-19 prophylaxis study (as this would have the potential to decrease the expected rate of covid-19 in this population and affect our power and sample size calculations) any 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) increased infection risk due to immunosuppression due to: chronic immunosuppressive medication prior organ or hematopoietic stem cell transplant known neutropenia (anc <500 cells/ul) hiv and cd4 <200 cells/ul increased infection risk due to endovascular due to: rheumatic heart disease congenital heart defect, mechanical heart valves endocarditis endovascular grafts permanent endovascular devices such as permanent (not short-term) hemodialysis catheters, pacemakers, or defibrillators increased infection risk due to mucosal gastrointestinal due to: gastroesophageal or intestinal injury, including active bleeding

2

Duke University

1

None

United States

Close contacts to covid patients

N/A

182

Incidence of one or more symptoms of COVID-19 during the study period

None

Not reported

[{"arm_notes": "nan", "treatment_id": 707, "treatment_name": "Lactobacillus", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]