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Trial - IRCT20200509047364N1


Column Value
Trial registration number IRCT20200509047364N1
Full text link
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Dr. Teamur Aghamolaei

Contact
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

research@hums.ac.ir

Registration date
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2020-08-09

Recruitment status
Last imported at : Aug. 1, 2021, 3 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

All definitively positive COVID-19 patients with Hb≤9. Having at least one of the severe symptoms of COVID-19, including tachypnea (breathing rate> 30 beats per minute), hypoxemia (O2 ≤93 saturation, the partial pressure ratio of arterial oxygen <300), Lung infiltration (> 50% of lung field within 24 to 48 hours), progressive lymphopenia, LDH>245 U/I, CRP>100

Exclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patients with a history of coagulopathy Patients with a history of thrombosis Patients with a history of deep vein thrombosis Patients with a history of chronic lung disease Patients with a history of diabetes mellitus Patients with weakened immune systems Patients with a history of end stage renal disease Patients with liver disease Patients with a history of taking oral contraceptive pills (OCPs) Patients with systolic blood pressure greater than 160 mmHg Patients with diastolic blood pressure greater than 90 mmHg Patients over 65 years of age Patients with erythropoietin above 500 Patients with a history of myocardial infarction or unstable angina Patients with a history of malignancy

Number of arms
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Bandare-abbas University of Medical Sciences

Inclusion age min
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

0

Inclusion age max
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

65

Countries
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

6: Severe disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

20

primary outcome
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Respiratory rate Oxygen saturation state and arterial oxygen partial pressure ratio Lung infiltration status LDH level's CRP level's Lymphocyte count Endogenous erythropoietin level's Patients' blood pressure

Notes
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 2

Arms
Last imported at : May 27, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 1076, "treatment_name": "Recombinant erythropoietin", "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"}]