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Trial - CTRI/2020/09/027904


Column Value
Trial registration number CTRI/2020/09/027904
Full text link
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Dr M Christopher

Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

dr.judith.chris@gmail.com

Registration date
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-09-18

Recruitment status
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1) Patients in the age group of 14 years and above <br/ >2) Both male and female patients <br/ >3) Confirmed cases of COVID 19 admitted for treatment in Shifa hospital, COVID positive confirmed by RT-PCR <br/ >4) Presence of IgM antibodies through rapid test kit <br/ >5) Willing to give consent for the study and take part actively <br/ >6) Patients willing to adhere to drugs protocol as per ICMR guidelines/ WHO guidelines <br/ >7) In test arm, patients who are accepting to AWB therapy in addition to standard drugs

Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1) Children lesser than 14 years of age <br/ >2) Presence of IgG antibodies through rapid test kit <br/ >3) Patients hypersensitive to blood products or blood transfusion <br/ >4) Any Co-morbid conditions <br/ >5) Patients who are critically ill are excluded from the study

Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Dr M Christopher

Inclusion age min
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

14

Inclusion age max
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

85

Countries
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

India

Type of patients
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

60

primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RT-PCR test turning negative is the end pointTimepoint: 14days

Notes
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 146, "treatment_name": "Autologous blood", "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"}]