Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • ARDS
  • Corona Virus Infection
  • COVID-19
  • RAAS
  • Thrombophilia
  • Thromboses, Deep Vein
  • Thromboses, Intracranial
  • Thrombosis
Type
Observational
Design
Observational Model: Ecologic or CommunityTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The study's protocol will cover the following steps: • Collected data from COVID-19 patients at admission will include: Descriptive general demographic data Previous pathologies and thrombosis risk factors Routine biological data (the blood routinely collected will also be used for SARS-Cov-2 specif...

The study's protocol will cover the following steps: • Collected data from COVID-19 patients at admission will include: Descriptive general demographic data Previous pathologies and thrombosis risk factors Routine biological data (the blood routinely collected will also be used for SARS-Cov-2 specific RT-PCR exam) Complete thrombophilic profile testing by multiplex PCR and reverse hybridization of DNA to assess the presence of prothrombotic genotypes: Factor V Leiden Factor V 4070 A G (Hr2) Factor II G20210A Methylenetetrahydrofolate reductase (MTHFR) C677T MTHFR A1298C Cystathionine ?-synthase (CBS) 844ins68 PAI-1 4G/5G Glycoprotein IIIa T1565C (HPA-1a/b) ACE-DEL/INS Apolipoprotein E (ApoE) AGT M235T Angiotensin II type 1 receptor (ATR-1) A1166C Fibrinogen - 455 G A Factor XIII Val34Leu SpO2, respiratory rate, PaO2/FiO2 RAAS components Imagistic procedures (chest X-ray or CT) All patients with a positive SARS-CoV-2 PCR test will be included Patients will be divided into three groups depending on disease severity and the presence of thrombotic state: 1st group includes COVID-19 patients with proved venous thrombosis (deep vein thrombosis, pulmonary embolism or venous thrombosis occurring in more atypical places such as in the veins of the brain, liver, kidney, mesenteric vein and the veins of the arms) or arterial thrombosis (heart attacks, strokes) 2nd group encompasses asymptomatic patients and those with mild or moderate disease, according to current guidelines, without thrombosis: no symptoms or evidence of lower respiratory disease by clinical assessment or imaging and a SpO2 ? 94% 3rd group includes severe disease, according to current guidelines, without thrombosis: respiratory frequency > 30 breaths per minute, SpO2 < 94%, PaO2/FiO2 < 300 mmHg, or lung infiltrates >50% Statistical methods will be employed to check for significant differences between prothrombotic mutations frequency and RAAS components levels for the three groups

Tracking Information

NCT #
NCT04519398
Collaborators
Not Provided
Investigators
Study Chair: Adrian Covic, Professor Gr T Popa University of Medicine and Pharmacy Iasi ROMANIA