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IRCT20200621047859N2 IRCT 2020-12-29 Motamed Cancer Institute Immune cell therapy for patients with COVID-19 related pneumonia using allogenic ex vivo NK cells NKCTC Phase I clinical trial using ex vivo-expanded allogeneic donor-derived NK cells in patients with lower respiratory disease (Moderate) caused by COVID-19. 2020-08-22 anticipated 15 Complete https://irct.ir/trial/49382 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 SARS-COV-2 related pneumonia. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Decision will be made after sampling
public Dr Ramin Sarrami Forooshani
No146-Vanaq- South Ghandi- Square
Tehran Iran (Islamic Republic of) 1517964311 +98 21 8879 6003 rsf1351@gmail.com Iranian academic center for education culture and research scientific Dr Ramin Sarrami Forooshani
No 146-South Ghandi-Vanaq Aquare
Tehran Iran (Islamic Republic of) 1517964311 +98 21 8879 6003 rsf1351@gmail.com Iranian academic center for education culture and research Iran (Islamic Republic of) 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) 18 years no limit Both 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 B34.2 Coronavirus infection, unspecified Treatment - Other Treatment - Other 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. 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. 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. Improve severe respiratory symptoms. Timepoint: Daily to release date. Method of measurement: Blood oxygen levels, respiration volume, physical examinations. 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. Modiriat Atiye Bahman Company Motamed Cancer Institute Modiriat Atiye Bahman Company Approved 2020-05-06 Research Ethics Committee of Motamed Cancer Institute Academic Center for Education Culture and Rese No 146- South Ghandi-Vanaq Square Tehran Tehran Iran (Islamic Republic of)