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Trial - CTRI/2021/05/033867


Column Value
Trial registration number CTRI/2021/05/033867
Full text link
Last imported at : Sept. 8, 2021, 1:30 a.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 Raja Dhar

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

pulmoresearch@gmail.com

Registration date
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-05-31

Recruitment status
Last imported at : Sept. 8, 2021, 1:30 a.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 : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Sept. 8, 2021, 1:30 a.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)

Able to give informed consent � Male or female, age 40to 90 years � Typical symptoms of COVUD-19 infection: new onset of or exacerbation of cough due to chronic respiratory illness, dyspnea, Increased body temperature (forehead T° >37.6°C, oral T° >38°C, axillary >37.5°C) � SARS-CoV-2 infection demonstrated by PCR � Admission to hospital within 10 days of onset of symptoms

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

Hypersensitivity to doxycycline, myasthenia gravis, pregnancy, hepatic failure (CHILD-Pugh score C), unable to give informed consent

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 : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

You Breathe We Care

Inclusion age min
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

40

Inclusion age max
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

90

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 : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

250

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

Admission to ICUTimepoint: Day zero to Day 14

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 : Sept. 8, 2021, 1:30 a.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": 418, "treatment_name": "Doxycycline", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]