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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05092724 |
|
Full text link
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
2021-10-25 |
|
Recruitment status
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
unclear |
|
Study aim
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
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
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
- 1- patients with hemodynamic instability or multiorgan failure 2- failure to obtain temporary vascular access under ultrasound guidance or due to bleeding tendency. |
|
Number of arms
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
Zagazig University |
|
Inclusion age min
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
80 |
|
Countries
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
None |
|
Type of patients
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
Critical disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
8: Critical disease at enrollment |
|
Total sample size
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
20 |
|
primary outcome
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
• To evaluate the effect of increasing fetal hemoglobin protocol on the outcome in patients with fulminant COVID-19 |
|
Notes
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "transfusion", "treatment_id": 2011, "treatment_name": "Fetal hemoglobin", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |