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.
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
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| standard protocol of manaegement | No intervention | Not described |
| fetal blood | Active comparator | Not described Receives: Procedure: fetal blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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)
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.
- First posted25 Oct 2021
- Study start1 Dec 2021 (estimated)
- Primary completion19 Feb 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Essamedin Mamdouh Negm, Zagazig University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Fetal Hemoglobin a Key for Improvement of Hypoxia and Saving Last Breath in COVID-19 Patient?. A Pilot Study.
- ClinicalTrials.gov ID
- NCT05092724
- Acronym / sponsor ID
- #:8046-10-10-2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 19 Feb 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard protocol of manaegement | No intervention | – |
| fetal blood | Active comparator | Procedure: fetal blood transfusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Admitted covid 19 patients to the ICU with the following criteria : :
Key exclusion criteria (1 listed)
- 1- Patients with hemodynamic instability or multiorgan failure 2- Failure to obtain temporary vascular access under ultrasound guidance or due to bleeding tendency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fetal blood transfusiontransfusion of fetal blood | Procedure or surgery | fetal blood |
Primary outcome
• 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
To show how fetal blood transfusion (cord blood ) improve the outcome of COVID 19 patient ( mortality)
1 secondary outcome
To evaluate the effect of increasing fetal hemoglobin protocol on the morbidity of patients with fulminant COVID-19
Time frame: allove 5 months . 10 days for each group .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
Related trials for COVID-19 Acute Respiratory Distress Syndrome
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Active, not recruitingPhase 1/2
Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
COVID-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome
Active, not recruitingPhase 2
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Acute Respiratory Distress Syndrome, Viral or Bacterial Infections
RecruitingPhase 1/2
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 and/or Acute Respiratory Distress Syndrome (THYTECH2)
Systemic Inflammatory Response Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.