COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04453371


Column Value
Trial registration number NCT04453371
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04453371

First author
Last imported at : March 14, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Valery Likhvantsev

Contact
Last imported at : March 14, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

lik0704@gmail.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-07-01

Recruitment status
Last imported at : March 14, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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 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
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 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).

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Negovsky Reanimatology Research Institute

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : March 14, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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.

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 71, "treatment_name": "Alteplase", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]