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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 |
|
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"}] |