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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200415047080N1

Enrollment

Registered

2020-11-02

Start date

2020-09-22

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. COVID-19 induced ARDS

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

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

Exclusion criteria: Bleeding tendency Coagulopathy (INR>1.5) Thrombocytopenia (plt 12) Major trauma in the prior 30 days Moribund patient not expected to survive the next 24 hours. No consent/inability to obtain consent

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRasoul Aliannejad

Tehran University of Medical Sciences

aliannejad@tums.ac.ir+98 21 8490 2260

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026