Effectiveness of Tissue plasminogen activator (TPA) for treatment of ARDS induced by Covid-19

Phase 3

Recruiting

Conditions: COVID-19.
COVID-19 induced ARDS
U07.1

Registration Number: IRCT20200415047080N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.