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Is Fetal Hemoglobin a Key for Improvement of Hypoxia and Saving Last Breath in COVID-19 Patient?. A Pilot Study.

Primary Purpose

COVID-19 Acute Respiratory Distress Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fetal blood transfusion
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admitted covid 19 patients to the ICU with the following criteria : :

    • Hypoxia (P/F less than 100)
    • Need for high level of oxygenation or ventilatory support
    • Tachypnea, respiratory distress due to hypoxia
    • >50 percent involvement of the lung parenchyma on chest imaging .

      • Serum IL-6 ≥ 5 x upper normal limit of daily increase of >1 time
      • Ferritin >300 ug/L with doubling within 24 hours
      • Ferritin >600 ug/L at presentation
      • LDH >250 U/L
      • Elevated D-dimer (>1 mg/L)

Exclusion Criteria:

  • 1- Patients with hemodynamic instability or multiorgan failure 2- Failure to obtain temporary vascular access under ultrasound guidance or due to bleeding tendency.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    standard protocol of manaegement

    fetal blood

    Arm Description

    Outcomes

    Primary Outcome Measures

    • To evaluate the effect of increasing fetal hemoglobin protocol on the outcome in patients with fulminant COVID-19
    To show how fetal blood transfusion (cord blood ) improve the outcome of COVID 19 patient ( mortality)

    Secondary Outcome Measures

    To evaluate the effect of increasing fetal hemoglobin protocol on the morbidity of patients with fulminant COVID-19
    To show how fetal blood transfusion (cord blood ) improve the morbidity of COVID 19 patient ( ICU days, M.V days ,oxygenation and perfusion parameters )

    Full Information

    First Posted
    October 19, 2021
    Last Updated
    November 20, 2021
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05092724
    Brief Title
    Is Fetal Hemoglobin a Key for Improvement of Hypoxia and Saving Last Breath in COVID-19 Patient?. A Pilot Study.
    Official Title
    Is Fetal Hemoglobin a Key for Improvement of Hypoxia and Saving Last Breath in COVID-19 Patient?. A Pilot Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    February 19, 2022 (Anticipated)
    Study Completion Date
    March 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In December 2019, a sudden public health incident (the corona virus disease [COVID-19] epidemic) occurred in Wuhan, China. Clinical features of those with pneumonia include fever and cough, and in many cases a sudden and accelerating respiratory distress originated from interstitial pneumonia . Many hypotheses have explained hypoxemia in COVID-19 patients, such as hyperimmune reaction to viral infection and cytokine storm that leads to serious lung tissue and alveolar damage or even direct viral insult . Mortality are as high as 15% in critically ill patients requiring intensive care unit admission and oxygen therapy , suggesting an urgent need to try therapeutic interventions in addition to supportive treatment. There is more than one type of hemoglobin. In adults, Hb A or Adult hemoglobin which is the main hemoglobin in the blood. But there is another type of hemoglobin called fetal hemoglobin. Fetal hemoglobin (hemoglobin F, Hb F, or α2γ2) is the main oxygen carrier protein in the human fetus. and the levels remain high after birth until the baby is roughly 2-4 months old . Hemoglobin F has a different composition from hemoglobin A and higher affinity to oxygen . At birth, hemoglobin F accounts for 50-95% of the infant's hemoglobin and at around 6 months after birth, hemoglobin A becomes the predominant type.The key feature that allows hemoglobin F to bind more strongly to oxygen is by having γ subunits (instead of β, in Hb A for example). 2,3-BPG interacts much more with hemoglobin A than hemoglobin F . A hypothesis for the low incidence of the COVID-19 infection in pediatric is the presence of fetal hemoglobin (HbF) . In a preliminary study about the prevalence of hemoglobinopathies in different countries and the mortality rate of COVID-19, it appears that the mortality is lower in countries with a higher prevalence of hemoglobinopathies . Mice treated with GBT1118 (a compound that enhances the oxygen affinity of hemoglobin) showed a sustained significant increase in SpO2 over 4 h of hypoxia exposure. People with haemoglobinopathies like sickle cell anemia or beta-thalassemia attributed with high amount of fetal hemoglobin, become mostly asymptomatic or have mild symptoms . The volume of umbilical cord blood varies from 50 ml to 140 ml with a mean of 85 ml rich in fetal hemoglobin . Mesenchymal stem cells (MSCs) have been widely used in the clinical setting, not only for autoimmune diseases but also for infectious diseases , and their safety and effectiveness have been well elucidated . As a noninvasive treatment, hUC-MSC therapy is a very effective and promising method for clinical application and promotion to treat severe COVID-19 the investigators offer a solution by increasing fetal hemoglobin by cord blood containing fetal blood transfusion in the critical patients as a trial to combat the course of the disease and minimize the morbidity especially in sever cases who suffer from desaturation until suppression of the immune dysregulation and avoidance of the impending death.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19 Acute Respiratory Distress Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    standard protocol of manaegement
    Arm Type
    No Intervention
    Arm Title
    fetal blood
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    fetal blood transfusion
    Intervention Description
    transfusion of fetal blood
    Primary Outcome Measure Information:
    Title
    • To evaluate the effect of increasing fetal hemoglobin protocol on the outcome in patients with fulminant COVID-19
    Description
    To show how fetal blood transfusion (cord blood ) improve the outcome of COVID 19 patient ( mortality)
    Time Frame
    for 10 cases for each group ( pilot study ) allover about 5 months
    Secondary Outcome Measure Information:
    Title
    To evaluate the effect of increasing fetal hemoglobin protocol on the morbidity of patients with fulminant COVID-19
    Description
    To show how fetal blood transfusion (cord blood ) improve the morbidity of COVID 19 patient ( ICU days, M.V days ,oxygenation and perfusion parameters )
    Time Frame
    allove 5 months . 10 days for each group .

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Admitted covid 19 patients to the ICU with the following criteria : : Hypoxia (P/F less than 100) Need for high level of oxygenation or ventilatory support Tachypnea, respiratory distress due to hypoxia >50 percent involvement of the lung parenchyma on chest imaging . Serum IL-6 ≥ 5 x upper normal limit of daily increase of >1 time Ferritin >300 ug/L with doubling within 24 hours Ferritin >600 ug/L at presentation LDH >250 U/L Elevated D-dimer (>1 mg/L) Exclusion Criteria: 1- Patients with hemodynamic instability or multiorgan failure 2- Failure to obtain temporary vascular access under ultrasound guidance or due to bleeding tendency.

    12. IPD Sharing Statement

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    Is Fetal Hemoglobin a Key for Improvement of Hypoxia and Saving Last Breath in COVID-19 Patient?. A Pilot Study.

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