Trial NCT04414124
Publication Haran J, medRxiv, 2021 (preprint)
Dates: 2020-07-02 to 2020-12-23
Funding: Private (Kaleido Biosciences, Inc.)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / USA Follow-up duration (days): 35 | |
| Inclusion criteria | ≥18 years of age; tested positive for COVID-19; mild to moderate COVID-19; self-reported outpatient management. Patients symptomatic at the time of COVID-19 testing must have reported new or worsening symptoms at baseline that were not present for more than 5 days; symptomatic patients were screened and randomized within 48 hours of a positive COVID-19 test result; Patients pre-symptomatic at the time of testing had to report new cardinal symptoms within 7 days of a positive test result and were screened and randomized within 5 days of developing symptoms; Patients were also required to have consistent internet or cellphone access with a data plan and access to a smartphone, tablet, or computer. |
| Exclusion criteria | Likely to require hospitalization for COVID-19 or hospitalized for inpatient treatment ; currently being evaluated for potential hospitalization at the time of informed consent for conditions other than COVID-19. |
| Interventions | |
| Treatment
KB109 Escalating dose schedule: 9 g orally 2 times a day on days 1 and 2; 18 g orally 2 times a day on days 3 and 4; and 36 g orally 2 times a day on days 5 through 14. |
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| Control
Standard care ( / ) Definition of Standard care: Supportive self care included over-the-counter cough, cold, and anti-pyretic medication that was used as necessary by patients in accordance with their respective drug facts label or as instructed by their healthcare provider. | |
| Participants | |
| Randomized 350 participants (n1=174 / n2= 176) | |
| Characteristics of participants N=350 Mean age : NR 143 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 to Day 35 ] | |
| In the report Number of patients experiencing KB109-related TEAEs | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated
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| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment |