Off-the-shelf NK Cells (KDS-1000) as Immunotherapy for COVID-19
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|ClinicalTrials.gov Identifier: NCT04797975|
Recruitment Status : Withdrawn (The sponsor decided to withdraw this study)
First Posted : March 15, 2021
Last Update Posted : August 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Biological: KDS-1000 Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 1/2a Multicenter Randomized Double-blind Placebo-controlled Trial of Off-the-shelf Natural Killer Cells (KDS-1000) as Immunotherapy for Adult Patients With Mild to Moderate COVID-19 Symptoms at Risk for Complications|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
NK cells expanded ex vivo using PM21 membrane particles:
Non-randomized part of study:
Randomized part of the study (Can start when there are no safety concerns in the non-randomized cohorts):
Placebo Comparator: Control
0.9% Normal Saline
0.9% Normal Saline
- Determine the safety of KDS-1000 given at low and high doses compared to placebo by collecting the rate and severity of adverse events (AE) [ Time Frame: 28 Days ]Rate and severity of AE.
- Determine the efficacy KDS-1000 given at low and high doses compared to placebo by COVID-19 specific questionnaire. [ Time Frame: 90 Days ]Improvement in COVID-19 disease symptoms/progression of disease.
- Determine the efficacy KDS-1000 given at low and high doses compared to placebo by measurement of SARS-CoV-2 clearance. [ Time Frame: 28 days ]Determined by real time reverse transcription polymerase chain reaction (rRT-PCR).
- Determine the safety of KDS-1000 given at low and high doses compared to placebo by collecting the rate and severity of AE. [ Time Frame: 90 Days ]Rate and severity of AE.