NK Cells Treatment for COVID-19

Conditions

Novel Coronavirus Pneumonia

Brief summary

Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.

Hernández-Blanco C, Al-Akioui-Sanz K, Herrera L, Aguirre-Portolés C, Lozano-Ojalvo D, Pérez-Rodriguez L, Cano-Ochando J, Guerra-García P, Martín-Quirós A, Vicario JL, Santos S, Pérez-Vaquero MÁ, Vesga MÁ, Borobia AM, Carcas AJ, Balas A, Moreno MÁ, Pérez de Diego R, Gasior M, Soria B, Eguizabal C, Pérez-Martínez A.

2024-12-271 citations

10.1016/j.isci.2024.111698

Safety and feasibility study of ex vivo expanded allogeneic-NK cells infusion in patients with acute pneumonia caused by COVID-19

Mohammad Ahmadvand, Mahdieh Shokrollahi Barough, Zahra Sadat Hashemi, Hassan Sanati, Fereshteh Abbasvandi et al. (12 authors)

Pilot and Feasibility Studies2023-08-0416 citations

10.1186/s40814-023-01355-6

A phase I/II dose-escalation multi-center study to evaluate the safety of infusion of natural killer cells or memory T cells as adoptive therapy in coronavirus pneumonia and/or lymphopenia: RELEASE study protocol

Irene García-García, Pilar Guerra‐García, Cristina Ferreras, Alberto M. Borobia, Antonio J. Carcas et al. (12 authors)

Trials2021-10-0212 citations

10.1186/s13063-021-05625-7

Interventions

BIOLOGICALNK Cells

twice a week of NK cells (0.1-2\*10E7 cells/kg body weight)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* 1\. Male or female, aged at 18 years-65 years old * 2\. Pneumonia that is judged by chest radiograph or computed tomography * 3\. Laboratory confirmation of NCP infection by reverse-transcription polymerase chain reaction(RT-PCR) from any diagnostic sampling source

Exclusion criteria

* 1\. Pregnancy or breastfeeding * 2\. Known HIV, HBV or HCV infection * 3\. Patients with malignant tumor, other serious systemic diseases and psychosis * 4\. Patients who are participating in other clinical trials * 5\. Inability to provide informed consent or to comply with test requirements

Design outcomes

Primary

Measure	Time frame	Description
Improvement of clinical symptoms including duration of fever	Measured from day 0 through day 28	Evaluation of pneumonia improvement
Improvement of clinical symptoms including respiratory frequency	Measured from day 0 through day 28	Evaluation of pneumonia improvement
Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0	Measured from day 0 through day 28	Safety evaluation

Secondary

Measure	Time frame	Description
Time of virus nucleic acid test negative	Measured from day 0 through day 28	Marker for 2019-nCoV
Size of lesion area by thoracic imaging	Measured from day 0 through day 28	Recovery of lung injury
CD4+ and CD8+ T cell count	Measured from day 0 through day 28	Marker of immunological function
Rate of mortality within 28-days	Day 28	Marker for efficacy of treatment

Countries

China

Outcome results

None listed