Tissue Plasminogen Activator for COVID-19-induced Severe Acute Respiratory Distress Syndrome: A Controlled Clinical Trial.

Abstract

Objective: This study aimed to assess the safety and efficacy of tissue Plasminogen Activator (tPA) in patients with COVID-19-induced severe Acute Respiratory Distress Syndrome (ARDS).

Methods: The intervention group consisted of eligible patients with severe ARDS due to COVID-19 admitted to the Intensive Care Unit (ICU) of a university hospital. We selected the control group from admitted patients treated in the same ICU within the same period. The intervention group received intravenous tPA as 10 mg stat, 40 mg over the first 2 hours, and 25-50 mg over the next 10 hours, followed by a therapeutic dose of enoxaparin. The control group only received the therapeutic dose of enoxaparin. The main outcomes were the rise of SpO2 within 24 hours of tPA administration, critical bleeding during tPA administration, 28-day in-hospital mortality following admission to the ICU, and length of stay in the ICU.

Results: We analyzed two sets of 15 patients in the intervention (mean age: 45 years, 69% male) and the control (mean age: 50 years, 50% male) groups. There was rapid relief of dyspnea and SpO2 rising within 24 hours in seven cases (45%) only in the intervention group with no significant organ-threatening bleeding. Death was observed in 5 of the tPA-treated patients (33.3%) versus 10 (66.7%) of the controls [adjusted OR (95%CI): 0.17 (0.03, 0.98), P value =0.068].

Conclusion: The administration of intravenous tPA as 10mg stat, 40 mg during 2 hours, and 50mg during the next 10 hours is safe, can cause a rapid relief of dyspnea, and be lifesaving.