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COVID-19 Acute Respiratory Distress SyndromeNCT05092724

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

A study testing fetal blood transfusion in people with COVID-19 Acute Respiratory Distress Syndrome, run by Zagazig University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
fetal blood transfusion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 Dec 2021to 31 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

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

About this study

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 .

Read more

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.

Being tested
fetal blood transfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fetal blood transfusionProcedure or surgery

    transfusion of fetal blood

Study groups in NCT05092724
Study groupRoleWhat they receive
standard protocol of manaegementNo interventionNot described
fetal bloodActive comparatorNot described
Receives: Procedure: fetal blood transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • 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)

    Measured: for 10 cases for each group ( pilot study ) allover about 5 months

Secondary outcomes (1)
  1. 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 )

    Measured: allove 5 months . 10 days for each group .

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion19 Feb 2022 (estimated)
  4. Study completion31 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05092724
Sponsor's protocol ID
#:8046-10-10-2021
Status last verified
Nov 2021
First submitted
19 Oct 2021
Last updated
23 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing fetal blood transfusion in people with COVID-19 Acute Respiratory Distress Syndrome, run by Zagazig University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• To evaluate the effect of increasing fetal hemoglobin protocol on the outcome in patients with fulminant COVID-19 (time frame: for 10 cases for each group ( pilot study ) allover about 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.

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