COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04486482

Mark Wingertzahn, PhD

clinicalstudies@kaleido.com

2020-07-24

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

to be considered for enrollment into this study, each patient must meet all of the following inclusion criteria: be male or female, ≥18 years of age be willing and able to give informed consent screening/randomization telemedicine visit within 2 days of testing positive test for covid-19 having self-reported fever or cough for not more than 72 hours prior to covid-19 testing mild to moderate covid-19 able to adhere to the study visit schedule and other protocol requirements patients who meet any of the following exclusion criteria at the randomization visit will not be enrolled into the study: patients who are hospitalized for in-patient treatment or currently being evaluated for potential hospitalization at the time of informed consent for conditions other than covid-19 history of chronic lung disease ongoing requirement for oxygen therapy shortness of breath in resting position diagnosis of sleep apnea requiring bilevel positive airway pressure (bipap) / continuous positive airway pressure (cpap) female patients who are pregnant, trying to become pregnant or lactating. is considered, in the opinion of the pi, to be unlikely for any reason to be able to comply with study procedures

None

2

Kaleido Biosciences

18

100

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

49

Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)

None

Not reported

[{"arm_notes": " ", "treatment_id": 701, "treatment_name": "Kb109", "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"}]