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IRCT20200217046526N2 IRCT 2020-04-13 Iranian academic center for education culture and research Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection: A Phase 2-3 Clinical Trial 2020-04-05 anticipated 60 Complete https://irct.ir/trial/47073 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The study will be done for the first ten of each intervention and then for the second ten of each intervention groups, Randomization description: Participants were randomly divided into three equal groups using a randomized tripled ABC blocking method based on a random number table. 2-3 Acute Respiratory Distress Syndrome of COVID-19. Intervention 1: Intervention group: The intervention group 1, Patients will receive three doses of MSCs. Two doses of 100×10e6 (±10%) cells will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0 and day 2. Intervention 2: The intervention group 3, Patients will receive two doses of MSCs intravenously and EVs. Two doses of 100×10e6 (±10%) MSCs will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0 and day 2. In days 4 and 6, the patients will receive two times the infusion of MSCs-EVs. Intervention 3: Control group: Patients will receive conventional therapy. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD can be shared When: 6 months after publication To whom: Researchers and clinicians Conditions: Planning of similar studies in other academic centers Where to obtain: Email How to obtain: 1-2 months after request Comments:
public Morteza Zarrabi
No. 2, Hafez St., Banihashem St., Resalat Ave
Tehran Iran (Islamic Republic of) 16635148 +98 21 2233 9940 m.zarrabi@rsct.ir Royan Institute scientific Hossein Baharvand
No. 2, Hafez St., Banihashem St., Resalat Ave
Tehran Iran (Islamic Republic of) 16635148 +98 21 2230 6485 hossein.baharvand@gmail.com Royan Institute Iran (Islamic Republic of) Iran (Islamic Republic of) Confirmation of 2019-nCoV infection by RT-PCR Diagnosis of ARDS according to the Berlin definition of ARDS Requiring supplemental oxygen, OR Pneumonia that is judged by chest radiograph or CT PaO2/oxygen absorption concentration (FiO2) ≤ 300MMHG Pulmonary imaging shows that the focused progress > 50% in 24-48 hours Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU <48 hours SOFA score between 2-3 point 18 years 65 years Both Severe allergies or allergies after 1st injection to stem cell preparations and their components Patients with a malignant tumor, other serious systemic diseases, and psychosis Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus Patients with previous history of pulmonary embolism Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections) Liver or kidney SOFA score of more than 3 points; combined with other organ failure (need organ support), Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30) Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia Continuous use of immunosuppressive agents or organ transplants in the past 6 months In vitro life support (ECMO, ECCO2R, RRT) Pregnant or lactating women Uncontrolled underling disease U07.1 COVID-19 Treatment - Other Treatment - Other Treatment - Other Intervention group: The intervention group 1, Patients will receive three doses of MSCs. Two doses of 100×10e6 (±10%) cells will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0 and day 2. The intervention group 3, Patients will receive two doses of MSCs intravenously and EVs. Two doses of 100×10e6 (±10%) MSCs will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0 and day 2. In days 4 and 6, the patients will receive two times the infusion of MSCs-EVs. Control group: Patients will receive conventional therapy Adverse events assesment. Timepoint: At the same time of each intervention, 24 hours after each intervention, on days 6, 7, 14 and 28 after the first intervention. Method of measurement: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Blood oxygen saturation. Timepoint: At Baseline, simultaneously with each intervention and on days 5, 6, 7, 14 after the first intervention. Method of measurement: Evaluation of Pneumonia Improvement. Biomarkers concentrations in plasma. Timepoint: At baseline, 7, 14, 28 days after the first intervention. Method of measurement: Biochemical examination. Respiratory efficacy. Timepoint: From baseline to day 7. Method of measurement: Evaluated by the increase in PaO2/FiO2 ratio. Intensive care unit-free days. Timepoint: Up to day 8. Method of measurement: Number of day. Change in clinical symptoms. Timepoint: At Baseline, simultaneously with each intervention and on days 5, 6, 7, 14 after the first intervention. Method of measurement: Evaluation of Pneumonia Improvement. National Institute for Medical Research Development Iranian academic center for education culture and research National Institute for Medical Research Development Approved 2020-03-12 Ethic committee of National Institute for Medical Research Development No 21, Besat Street., Western Fatimid Street Tehran Tehran Iran (Islamic Republic of)