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Phase I clinical trial using ex vivo-expanded allogeneic donor-derived NK cells in patients with lower respiratory disease (Moderate) caused by COVID-19.

Protocol summary

Study aim
Determination of the treatment side effects such as fever, rash, changes in blood homeostasis and blood sugar, cardiopulmonary problems after allogeneic Natural Killer Cell (NK cell) infusion in treatment-resistant Coronavirus disease 2019 (COVID-19) patients. • Determining the percentage of lung saturation in computerized tomography (CT)-Scan graphs of patients before and after allogeneic NK cell infusion in patients with resistant COVID-19
Design
8 patients in the case group and 6 patients in the control group are nominated for cell therapy and vital signs, allergic reactions after injection are monitored until release.
Settings and conduct
Intravenous injection of NK cells to patients with COVID-19 related severe pneumonia (2x10^6 cell /kg) in the intensive care unit (ICU) and infusion safety assessment in patients until the release date
Participants/Inclusion and exclusion criteria
Inclusion Criteria - pneumonia that is confirmed by chest imaging (glass turbidity in HRCT) - Laboratory Confirmation of Infection (NCP, Novel Coronavirus Pneumonia,) with Reverse chain Polymerase (RT-PCR) - Ordinary transthoracic echocardiogram Exclusion Criteria -A known case of HBV, HIV, HCV -Patients with other serious systemic diseases or malignancies
Intervention groups
1. Patients with "treatment-resistant" pneumonia of COVID-19 infection will receive one-dose of NK cell infusion (2-10x10^6/Kg). The routine treatments will not be stopped. 2. Control Group: Patients with "treatment-resistant" pneumonia of COVID-19 infection who are aligned with group1 in case of age, body weight, and clinical status. They will not receive cell therapy and the routine treatment would be executed.
Main outcome variables
Safety assessment in case of allergic symptoms evaluation such as fever, Heart rate, Pulse rate, artemia cardiac, Respiratory rate, saturation status, and reduction of acute respiratory symptoms

General information

Reason for update
Acronym
NKCTC
IRCT registration information
IRCT registration number: IRCT20200621047859N2
Registration date: 2020-12-29, 1399/10/09
Registration timing: retrospective

Last update: 2020-12-29, 1399/10/09
Update count: 0
Registration date
2020-12-29, 1399/10/09
Registrant information
Name
Ramin Sarrami Forooshani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 6003
Email address
rsf1351@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
2020-09-01, 1399/06/11
Actual recruitment end date
2020-09-08, 1399/06/18
Trial completion date
2020-12-08, 1399/09/18
Scientific title
Phase I clinical trial using ex vivo-expanded allogeneic donor-derived NK cells in patients with lower respiratory disease (Moderate) caused by COVID-19.
Public title
Immune cell therapy for patients with COVID-19 related pneumonia using allogenic ex vivo NK cells
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Man or woman, aged 18-70 years pneumonia that is confirmed by chest imaging (glass turbidity in High-resolution computed tomography[HRCT]) Laboratory confirmation of infection (NCP, Novel Coronavirus Pneumonia) with reverse polymerase chain reaction (RT-PCR) response from any diagnostic sampling source. Ordinary transthoracic echocardiogram Adequate kidney function, which is estimated based on glomerular filtration rate (CrCl> 60) ml / min or ml per minute / 1.73 square meters, (CrCl: Creatinine Clearance)
Exclusion criteria:
Pregnancy or lactation Infection for human immunodeficiency viruses (HIV) , hepatitis B virus (HBV) or hepatitis C virus (HCV) Patients with other serious systemic diseases or malignancies Inability to provide informed consent or compliance with test conditions
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 15
Actual sample size reached: 14
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Motamed Cancer Institute Academic Center for Education Culture and Rese
Street address
No 146- South Ghandi-Vanaq Square
City
Tehran
Province
Tehran
Postal code
1517964311
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.ACECR.IBCRC.REC.1399.005

Health conditions studied

1

Description of health condition studied
SARS-COV-2 related pneumonia
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Possible hypersensitivity, Allergy symptoms
Timepoint
Daily to release date
Method of measurement
Physical examinations, Vital signs and respiratory symptoms monitoring via ICU equipment's and blood tests

2

Description
Improve severe respiratory symptoms
Timepoint
Daily to release date
Method of measurement
Blood oxygen levels, respiration volume, physical examinations

3

Description
Anaphylactic shock
Timepoint
Daily to release date
Method of measurement
Physical examinations, Vital signs and respiratory symptoms monitoring via ICU equipment's and blood tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with resistant pneumonia caused by COVID-19 infection with acute symptoms of pneumonia who have not responded to routine treatments. This group will receive 2 to 10*10^6 cells/Kg Good manufacturing practices (GMP)-grade Natural Killer cell infusion over 10 minutes. The common treatments of patients will not be stopped.
Category
Treatment - Other

2

Description
Control group: Patients with resistant pneumonia caused by COVID-19 infection with acute symptoms of pneumonia who did not respond to routine treatments. This group would be normalized in case of age and gender and given routine treatments.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Dr Atefeh Abedini
Street address
No146-South Ghandi-Vanaq Square
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 6003
Email
dr.abedini110@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Motamed Cancer Institute
Full name of responsible person
Dr Keivan Majidzadeh Ardebili
Street address
No 146-South Ghandi -Vanaq Square
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 6003
Email
K1majidzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Motamed Cancer Institute
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

2

Sponsor
Name of organization / entity
Modiriat Atiye Bahman Company
Full name of responsible person
Sina Hasanalizadeh
Street address
No-1,Ghasemi-tabatabaei
City
Tehran
Province
Tehran
Postal code
1459973114
Phone
+98 21 8879 6003
Email
rsf1351@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Modiriat Atiye Bahman Company
Proportion provided by this source
90
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr Ramin Sarrami Forooshani
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
No146-Vanaq- South Ghandi- Square
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 6003
Email
rsf1351@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr Ramin Sarrami Forooshani
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
No 146-South Ghandi-Vanaq Aquare
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 6003
Email
rsf1351@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Mahdieh Shokrollahi Barough
Position
Professor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
No 146-South Ghandi-Vanaq Square
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 6003
Email
m-shokrollahi@farabi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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