CovidResearchTrials by Shray Alag

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Defibrotide 25 mg/kg 24 hours continuous infusion for 15 daysWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug619 Placebo 250 cc 24 hours continuous infusion for 15 days Wiki 1.00
drug553 Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Wiki 1.00

Correlated MeSH Terms (6)

Name (Synonyms) Correlation
D012141 Respiratory Tract Infections NIH 0.26
D003141 Communicable Diseases NIH 0.12
D014777 Virus Diseases NIH 0.11
D007239 Infection NIH 0.08
D045169 Severe Acute Respiratory Syndrome NIH 0.07
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.15

There is one clinical trial.

Clinical Trials

1 Phase IIb Prospective, Multi-center, Randomized, Parallel, Double Blind, Placebo Controlled Trial to Evaluate Defibrotide Intravenous Infusion in the Prevention and Treatment of COVID-19 Respiratory Distress and Cytokine Release Syndrome

Protection of endothelial dysfunction by intravenous infusion of Defibrotide (Defitelio), expected to decrease inflammation and expression of adhesion molecules in the endothelium, leukocyte tissue infiltration and epithelial destruction, and to promote immune tolerance through a change in the Cytokine balance, which is decisive in preventing multiorgan failure and death in patients with SARS-CoV-2 infection with clinical status grade 4, 5 or 6 according to the WHO classification

NCT04348383 COVID19 Drug: Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days Drug: Placebo 250 cc 24 hours continuous infusion for 15 days

Primary Outcomes

Description: All cause mortality

Measure: 1. Mortality rate

Time: : up to 30 days

Secondary Outcomes

Description: Decrease the rate of grades 4-5 patients requiring mechanical ventilation.

Measure: Clinical improvement by WHO

Time: 7, 15, 30 and 60 Day

Description: Decrease ventilation days in grade 6 patients

Measure: Clinical improvement by WHO

Time: 7, 15, 30 and 60 Day

Description: Decrease the rate of grades 4-5 patients requiring mechanical ventilation.

Measure: Clinical improvement by NEWS2 scales

Time: 7, 15, 30 and 60 Day

Description: Decrease ventilation days in grade 6 patients

Measure: Clinical improvement by NEWS2 scales

Time: 7, 15, 30 and 60 Day

Description: Decrease of IL-6 levels with respect to the basal ones > 50%.

Measure: Biologic response

Time: 7, 15, 30 and 60 Day

Description: Absolute lymphocytes count: 50% increase with respect to the baseline

Measure: Biologic response

Time: 7, 15, 30 and 60 Day

Description: Normal D-dimer (DD) or decrease of 50% with respect to the baseline

Measure: Biologic response

Time: 7, 15, 30 and 60 Day

Description: Normal CRP or decrease of 50% with respect to the baseline

Measure: Biologic response

Time: 7, 15, 30 and 60 Day

Description: Normal LDH or decrease of 50% with respect to the baseline

Measure: Biologic response

Time: 7, 15, 30 and 60 Day

Description: Normal CPK or decrease of 50% with respect to the baseline

Measure: Biologic response

Time: 7, 15, 30 and 60 Day

Description: Normal Ferritin or decrease of 50% with respect to the baseline

Measure: Biologic response

Time: 7, 15, 30 and 60 Day

Description: Improvement of radiological images by conventional radiology

Measure: Radiological response

Time: 7, 15, 30 and 60 Day

Description: improve the knowledge of the disease at the inclusion of the patients

Measure: Collection and storage of biological samples

Time: 15,30 days

No related HPO nodes (Using clinical trials)