An Observational Clinical Study to Evaluate COVID-19 Symptoms in "Long Hauler" Patients Who Participated in K031-120 or K032-120

Completed

• Conditions: COVID-19
• Interventions: Other: Self Supportive Care (SSC) Alone; Other: KB109 + Self Supportive Care

• Registration Number: NCT04814914
• Lead Sponsor: Kaleido Biosciences

Brief Summary

This observational clinical study aims to evaluate the presence of symptoms of COVID-19 infection in patients who participated in K031-120 or K032-120 ("long hauler").

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Study Start: 2021-03-25
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

Inclusion Criteria

• Have consented to participate over the telephone
• Have been randomized in either the K031-120 or K032-120 study

Exclusion Criteria

• Have withdrawn consent from K031-120 or K032-120

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Self Supportive Care (SSC) Alone	Self Supportive Care (SSC) Alone	-
KB109 + Self Supportive Care (SSC)	KB109 + Self Supportive Care	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with persistent COVID-19 symptoms for at least 12-weeks post-randomization in K031-120 or K032-120 study.	12-weeks from randomization in K031-120 or K032-120

Trial Locations

Locations (2)

HealthStar Research, LLC; 🇺🇸 Hot Springs, Arkansas, United States

Quad Clinical Research; 🇺🇸 Chicago, Illinois, United States