Impact of Tissue Plasminogen Activator (tPA) Treatment for an Atypical Acute Respiratory Distress Syndrome (COVID-19) (AtTAC)
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ClinicalTrials.gov Identifier: NCT04453371 |
Recruitment Status :
Withdrawn
(Our local committee has denied the approval request)
First Posted : July 1, 2020
Last Update Posted : March 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Respiratory Distress Syndrome | Drug: Tissue plasminogen activator Drug: Ringer solution | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Tissue Plasminogen Activator (tPA) Treatment for an Atypical Acute Respiratory Distress Syndrome (Microvascular COVID-19 Lung Vessels Obstructive Thromboinflammatory Syndrome (MicroCLOTS): A Multicentral Randomized Trial (AtTAC-trial) |
Estimated Study Start Date : | October 15, 2020 |
Estimated Primary Completion Date : | January 15, 2021 |
Estimated Study Completion Date : | February 15, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Study group
Thrombolysis
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Drug: Tissue plasminogen activator
In the study group, tPA (Alteplase) 25 mg i/v over 2 hours, followed by a 25 mg tPA infusion over the subsequent 22 hours. After the end of thrombolytic therapy, unfractionated heparin is administered i/v at a starting dose of 10 units / kg per hour. The target value of PTT is 40C-50C. In both groups patient's transfer from the heparin infusion to the introduction of low-molecular-weight heparins is performed after normalization of the D-dimer level. Other Name: Alteplase |
Placebo Comparator: Control group
Ringer's solution infusion
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Drug: Ringer solution
In the control group, an equivalent amount of Ringer's solution is administered. After 24 hours, the heparin infusion gets started, similar the described for study group. In both groups patient's transfer from the heparin infusion to the introduction of low-molecular-weight heparins is performed after normalization of the D-dimer level. |
- P/F (PaO2/FiO2) change during the first 72hrs after the end of the procedure in adult patients with severe atypical ARDS caused by SARS-2-CoV. [ Time Frame: Each 6 hours during first 3 days after the end of thrombolysis procedure. ]
- Ventilator-free time (days free from MV) for 28 days of observation. [ Time Frame: 28 days ]Calculated as 28 days - number of days when patient receive any kind of ventilatory support (MV + SV + NIV).
- Mortality in 28 days and 1 year after randomization despite of the reason. [ Time Frame: 28 days, 1 year after randomization ]
- Length of stay in the ICU [ Time Frame: 28 days ]Number of days when patient was in ICU
- Length of stay in hospital [ Time Frame: 28 days ]Number of days when patient was in hospital
- The time needed for "improvement of 2 points" according to WHO "Ordinal Scale for Clinical Improvement" [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month ]
- Chest radiographs on a daily basis and define barotrauma as the presence of new pneumothorax, pneumomediastinum, pneumoperitoneum, or subcutaneous emphysema. [ Time Frame: Daily up to extubation than once a week/or on attending intensivist's discretion up to 1 month ]
- Blood Pressure in millimetres of mercury [ Time Frame: Each 4 hours during first 2 weeks after the end of thrombolysis procedure. ]
- Heart Rate in beats per minute [ Time Frame: Each 4 hours during first 2 weeks after the end of thrombolysis procedure. ]
- Blood Oxygen Saturation [ Time Frame: Each 4 hours during first 2 weeks after the end of thrombolysis procedure. ]
- ECG Q-wave [ Time Frame: Each 24 hours during first 2 weeks after the end of thrombolysis procedure. ]
- ECG ST-segment [ Time Frame: Each 24 hours during first 2 weeks after the end of thrombolysis procedure. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Severe pulmonary coronavirus disease 19 (COVID 19) with suspect for MicroCLOTS (microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome)
- P/F ratio <200 mmHg> 70 mmHg
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a.) Contrast CT scan positive for pulmonary thrombosis, OR b.) Contrast CT scan negative for pulmonary thrombosis:
- D-Dimer > 10 mcg/mL, OR
- 5 < D-dimer < 10 mcg/mL and C Reactive Protein (CRP) > 100 mg/dL
Exclusion Criteria:
- Age < 18
- Pregnancy or breastfeeding
- Known allergy to iodinated contrast dye
- Severe vasoplegic shock: norepinephrine > 300 ng/kg*min
- Glomerular Filtration rate < 30 ml/min
- Active bleeding or absolute contraindication to anticoagulant therapy (Stroke (intracranial hemorrhage, hemorrhagic stroke), including a history of the last 6 months.; cancer of the Central nervous system and other localities with an increased risk of bleeding, vascular aneurysm, traumatic open heart massage, obstetric delivery, General operations, severe uncontrolled hypertension, gastric ulcer and 12-duodenal ulcer (for 3 months. from the moment of exacerbation), arterial or venous malformations, liver failure, liver cirrhosis, portal hypertension, esophageal varicose veins, active hepatitis).
Responsible Party: | Negovsky Reanimatology Research Institute |
ClinicalTrials.gov Identifier: | NCT04453371 |
Other Study ID Numbers: |
tPA-2020 |
First Posted: | July 1, 2020 Key Record Dates |
Last Update Posted: | March 12, 2021 |
Last Verified: | March 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 MicroCLOTS Atypical Acute Respiratory Distress Syndrome |
COVID-19 Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Syndrome Disease Pathologic Processes Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury Tissue Plasminogen Activator Plasminogen Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |