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Trial - NCT04884490


Column Value
Trial registration number NCT04884490
Full text link
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Shohael Mahmud Arafat

Contact
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-05-13

Recruitment status
Last imported at : May 5, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

inclusion criteria - confirmed covid-19 patients by rt-pcr - clinically suspected covid-19 patients - age > 18 years - patients requiring oxygen at least> 5l/min up to 15 l/min (by fm/ nrm)to maintain saturation >92% to 96% note: clinically suspected covid-19 = fever (temperature >37.8 degree celsius) + respiratory symptoms + radiological evidences exclusion criteria - multi-organ failure - severe ards (requiring hfnc orventilatory support on presentation in the form ofinvasive or non-invasive ventilation) - septic shock - severe liver disease - acute heart failure - acute kidney injury (where gfr< 15 and plasma-sulfamethoxazoleconcentration cannot be monitored) - drug allergy/intolerance to co-trimoxazole / sulphar sensitivity - pregnancy

Exclusion criteria
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Number of arms
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Inclusion age min
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Bangladesh

Type of patients
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

94

primary outcome
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Length of stay in hospital (in days)

Notes
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 331, "treatment_name": "Cotrimoxazole", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]