Clinical trial NCT05092724: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: • To evaluate the effect of increasing fetal hemoglobin protocol on the outcome in patients with fulminant COVID-19
timeFrame: for 10 cases for each group ( pilot study ) allover about 5 months
Secondary outcomes:
measure: To evaluate the effect of increasing fetal hemoglobin protocol on the morbidity of patients with fulminant COVID-19
timeFrame: allove 5 months . 10 days for each group .
Other outcomes:
Locations:
Study officials:
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