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IRCT20140528017891N8 IRCT 2020-03-28 MOM research and innovation center The effect of stem cell transplantation in the treatment of COVID-19 Evaluation of the efficacy and safety of cord-derived mesenchymal stem cell transplantation in the treatment of COVID-19 2020-03-24 anticipated 10 Complete https://irct.ir/trial/46623 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use a randomization method to minimize the researchers' opinion to select participation in study groups to control bias. After selection, participants will be assigned to the groups using a simple randomization method for received intervention and placebo in each participant. The randomization process will be performed using Random Allocation software, and since this study consists of two groups, the allocation outputs of the participants will be identified by A and B so the assign of each patient in each group is unpredictable to other members of the research team. We will notify the team manager after selecting each patient and they will send out each patient's intervention type based on the software output, without the known of other team members. But only the clinical care will be aware of any patient's intervention in cases where the patient's condition is inappropriate, Blinding description: After selecting each patient to the study, the patients will be selected based on the randomization output was taken from the randomization software and matching it with the patient number of the intervention in such a way that both the patients and outcome assessor will not determine the type of intervention the patients receive. Blinding in this study was double blind. To maintain the blindness of the injection shape, color of the placebo will be similar to the main intervention so that patients and physicians evaluating the final outcome will be blind of the participant's interventions to minimize the bias in outcome measurement. 3 COVID-19. Intervention 1: Intervention group: In this group, mesenchymal stem cells will be injected at an initial dose of 0.5-1 milion/ kg. This process will be performed on the first, third and sixth days. This intervention will be done along with other treatments for this type of patients, varying in severity of COVID Infectious, and in accordance with national and international guidelines. Mesenchymal Stem Cell is GMP-approved by SinaCell. Intervention 2: Control group:This group, like the intervention group, will receive all routine medication according to national and international guidelines, depending on the severity of COVID-19. But on the first, third and sixth day, placebo (normal saline) will be injected. 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 Has not been proposed in the research team.
public Nader Tavakoli
Rasoul Akram Hospital, Niyayesh St, Sattarkhan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6653 9260 tavakoli.n@iums.ac.ir Iran University of Medical Sciences scientific Omid Moradimoghadam
Rasoul Akram Hospital, Niyayesh St, Sattarkhan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6653 9260 moradimoghadam.o@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients in acute phase Laboratory confirmation of SARS-COV-2 infection Pneumonia confirmed by chest x-ray or tomography Respiratory rate> 30 times / minute Oxygen Saturation less than 93% Arterial oxygen partial pressure (Pao2) /oxygen inhalation(Fio2) less than 300 mmHg No history of tumor or malignant disease 18 years 95 years Both Pregnant patient with a positive pregnancy test or during lactation or who is planning to become pregnant during the study The definitive history of acquired or inherited immune deficiency diseases The definitive psychotic illness A history of serious mental illness or a history of suicide The use of NG tube Creatinine greater than 1.7 or hepatic enzymes three times normal or white blood cell count lower than 3000 and hemoglobin less than 10 Co-infection of human immunodeficiency viruses, Hepatitis B, Hepatitis C and Human T-lymphotropic virus RA01.0 Severe Acute Respiratory Syndrome coronavirus Treatment - Drugs Placebo Intervention group: In this group, mesenchymal stem cells will be injected at an initial dose of 0.5-1 milion/ kg. This process will be performed on the first, third and sixth days. This intervention will be done along with other treatments for this type of patients, varying in severity of COVID Infectious, and in accordance with national and international guidelines. Mesenchymal Stem Cell is GMP-approved by SinaCell Control group:This group, like the intervention group, will receive all routine medication according to national and international guidelines, depending on the severity of COVID-19. But on the first, third and sixth day, placebo (normal saline) will be injected Death. Timepoint: Up to 28 days after starting the study. Method of measurement: Patient observation and evaluation of vital signs. Evaluation of Pneumonia Severity Index. Timepoint: Up to 28 days. Method of measurement: PSI. Evaluation of oxygen supply index. Timepoint: Discharge from ICU. Method of measurement: Pulse Oximeter. C- Reactive protein. Timepoint: 28 days or until the marker is normalized. Method of measurement: Blood sample. Procalcitonin. Timepoint: Until the marker is normalized. Method of measurement: Blood sample. Lymphocyte count. Timepoint: Until the marker is normalized. Method of measurement: CBC. Counting of CD3 +, CD4 + and CD8 + T cells. Timepoint: Before the first injection and after the third injection. Method of measurement: Flow cytometry. + CD4 + / CD8 ratio. Timepoint: Before the first injection and after the third injection. Method of measurement: Flow cytometry. Improve pneumonia evaluated by CT scan. Timepoint: After the second and third infusions. Method of measurement: CT scan. MOM research and innovation center Approved 2020-03-16 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)