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IRCT20200415047080N1 IRCT 2020-11-02 Tehran University of Medical Sciences Effectiveness of Tissue plasminogen activator (TPA) for treatment of ARDS induced by Covid-19 A prospective randomized controlled trial to compare recombinant tissue-type plasminogen activator (rt-PA) and standard treatmentin in patients with ARDS induced by COVID-19 2020-09-22 anticipated 30 Complete https://irct.ir/trial/47982 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to one of the intervention or control groups by quadruple block method. After determining the volume of each block, the letter A is considered for the intervention group and the letter B for the control group. All permutation combinations of the letters A, A, B and B, which are 6 different combinations, are written on 6 cards and a digit is randomly selected from the digits 1 to 6. For example, if the number 2 is selected, it means that the first person in the intervention group, the next two people in the control group and the fourth person in the intervention group and continue until the sample size reaches the quorum. 3 COVID-19. Intervention 1: Intervention group: 15 cases : A-Alteplase (TPA) 25-50 mg ( half of the maximum dose 0.9 / kg /day) over 2 hours intravenous continuing by 25-50 /22 hours up to maximum dose of 0.9 mg/kg/d. This tPA injection may be repeated for 2 days and the patient's condition (PT level PTT, SPO2 and D- dimer) is observed and checked. After the end of TPA injection, subcutaneous injection of Enoxaparin will be started as 1 mg per kilogram body weight for the patient. Enoxaparin could be continued up to 7 days upon the condition of the patient. The patients will receive regular care and treatment for COVID-19 induced ARDS. Intervention 2: Control group: They will take routine treatment approved by the Ministry of Health for patients with adult respiratory distress from COVID 19,Also the subcutaneous injection of Enaxaparin one mg per kilogram of body weight for the patient added to their treatment . 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 we will share our data after publishing article
public Rasoul Aliannejad
Shariati hospital,Jalal Al-Ahmad three ways,North Kargar street
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2260 aliannejad@tums.ac.ir Tehran University of Medical Sciences scientific Rasoul Aliannejad
Jalal Al-Ahmad three ways; North Kargar street
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2260 aliannejad@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) A person with laboratory confirmation of COVID-19 infection clinical and radiological confirmation of ARDS The confirm case of covid-19 in patients with ARDS (PaO2/FiO2a ≤ 300 or sat o2≤ 315 mmHg (with PEEP or CPAP ≥ 5 cmH2O, or non-ventilated) 18 years 70 years Both Bleeding tendency Coagulopathy (INR>1.5) Thrombocytopenia (plt< 50000) Previous hypersensitivity to Alteplase Active internal bleeding Severe uncontrolled hypertension Severe renal disease (GFR<50 ml/min) History of recent stroke Hemoptysis at admission Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years Moderate to severe liver failure (Childs-Pugh Score > 12) Major trauma in the prior 30 days Moribund patient not expected to survive the next 24 hours. No consent/inability to obtain consent U07.1 COVID-19 induced ARDS Treatment - Drugs Treatment - Drugs Intervention group: 15 cases : A-Alteplase (TPA) 25-50 mg ( half of the maximum dose 0.9 / kg /day) over 2 hours intravenous continuing by 25-50 /22 hours up to maximum dose of 0.9 mg/kg/d. This tPA injection may be repeated for 2 days and the patient's condition (PT level PTT, SPO2 and D- dimer) is observed and checked. After the end of TPA injection, subcutaneous injection of Enoxaparin will be started as 1 mg per kilogram body weight for the patient. Enoxaparin could be continued up to 7 days upon the condition of the patient. The patients will receive regular care and treatment for COVID-19 induced ARDS. Control group: They will take routine treatment approved by the Ministry of Health for patients with adult respiratory distress from COVID 19,Also the subcutaneous injection of Enaxaparin one mg per kilogram of body weight for the patient added to their treatment . The difference of PaO2/FiO2 or S/F ratio between two groups [ Time Frame: 72 h after randomization. Timepoint: 24 Hours from treatment till 72 h. Method of measurement: measurement of S/F ratio or Po2?Fio2 with pulseoxymetry or Arterial Blood gas (ABG). Disease severity. Timepoint: day 3,7, 14,28. Method of measurement: WHO 8-score ordinal scale. Survival in patients with ARDS. Timepoint: 28 day after treatment. Method of measurement: observation of patients status. Time to Ventilator Free state. Timepoint: from treatment time to two weeks. Method of measurement: counting the days. Adverse Drug Reaction after tratment. Timepoint: Daily. Method of measurement: patient status observation and lab data monitoring. Evaluation of ARDS mortality from COVID-19. Timepoint: From the time of admitted in the intensive care unit to the time of death. Method of measurement: Informed in clinical file. Evaluation of hospital discharge status of patients with ARDS caused by COVID-19. Timepoint: From the time of admitted in the intensive care unit to the time of discharge. Method of measurement: Informed in clinical file. Tehran University of Medical Sciences Approved 2020-03-23 Ethics Committee of Tehran University of Medical Sciences Dr. Shariati Hospital, Jalal Al-Ahmad Highway Tehran Tehran Iran (Islamic Republic of)