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Trial - IRCT20210714051887N1


Column Value
Trial registration number IRCT20210714051887N1
Full text link
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Masood Ziaee

Contact
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

dr.ziaee@gmail.com

Registration date
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-05-18

Recruitment status
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Open label

Center
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Willingness to participate in the studyPeople over the age of 18People with severe form of COVID-19 disease (shortness of breath, respiratory frequency ≥ 30 / min,, blood oxygen saturation ≤ 93%,, partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300,, percentage of pulmonary involvement more than 50 in 24-48 hours,)

Exclusion criteria
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

-

Number of arms
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Birjand University of Medical Sciences

Inclusion age min
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe disease at enrollment

Severity scale
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

6: Severe disease at enrollment

Total sample size
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

29

primary outcome
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Body temperature Blood Saturated Oxygen Levels C-reactive protein (CRP) Factor

Notes
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : May 19, 2022, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]