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Off-the-shelf NK Cells (KDS-1000) as Immunotherapy for COVID-19

NCT04797975 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-08-30

No results posted yet for this study

Summary

It is hypothesized that immunotherapy with off-the-shelf NK cells (KDS-1000) early in the course of COVID-19 disease is safe and may augment innate immunity, thereby limiting disease progression and improving survival.

Conditions

  • Covid19

Interventions

BIOLOGICAL

KDS-1000

Non-randomized part of study: * At the beginning of each dose level (Cohort), 3 patients will receive KDS-1000. These initial patients will be enrolled in a staggered manner to ensure detection of any early safety signals. Randomized part of the study (Can start when there are no safety concerns in the non-randomized cohorts): * Cohort 1: Low Dose, 2x10E8 cells/dose * Cohort 2: High Dose, 1x10E9 cells/dose

OTHER

Placebo

0.9% Normal Saline

Sponsors & Collaborators

  • Kiadis Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2021-04-30
Completion
2021-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04797975 on ClinicalTrials.gov