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Trial - IRCT20220517054899N1


Column Value
Trial registration number IRCT20220517054899N1
Full text link
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Vajehallah Raeesi

Contact
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Vajehraeesi@yahoo.com

Registration date
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-08-13

Recruitment status
Last imported at : March 22, 2023, 8 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Open label

Center
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Definitive diagnosis of Covid-19 based on taking a sample from the pharynx and PCR laboratory confirmation Lung involvement more than 50% SPO2 levels below 80% without oxygen or below 88% with oxygen or IL above 10 or ferritin above 1500 Patients who have not responded to other Covid-19 treatments Age over 18 years and consent to participate in the study

Exclusion criteria
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

History of albumin sensitivity Heparin allergy who cannot receive heparin as an anticoagulant during plasmapheresis Patients with hypocalcemia (citrate used in the plasmapheresis process exacerbates hypocalcemia)

Number of arms
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Birjand University of Medical Sciences

Inclusion age min
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe/critical disease at enrollment

Severity scale
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

40

primary outcome
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Percentage of blood oxygen saturation (SPO2) Arterial blood oxygen pressure in the analysis of blood gases Pao2

Notes
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Aug. 13, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 2337, "treatment_name": "Plasmapheresis", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]