COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN85874083

Syed Rehan Quadery

rehan.quadery@nhs.net

2021-02-09

Recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

Current inclusion criteria as of 13/05/2021: 1. Adult male or female individuals, age =18 years and =65 years 2. Patients giving written informed consent to participate in the study (ie GCS 15/15: conscious,Alert and oriented 3. COVID-19 documented by a positive RT-PCR test/Rapid Antigen Test 4. Hospitalised patients with severe COVID-19,requiring supplemental oxygen through non-re-Breath mask between 10 - 15L/min maintaining saturations between92-96% for up to 30 hours and between 94 - 98% for 1st six hours 5. Clinical/radiological evidence of interstitial pneumonia requiring admission(optional) _____ Previous inclusion criteria: 1. Aged between 18 and 65 years 2. COVID-19 infection documented by a positive RT-PCR test 3. Hospitalised with severe COVID-19 infection, characterized by fever (at the time of screening or when admitted) and requiring supplemental oxygen through non-rebreather mask between 10 and 15 l/ min 4. Clinical/radiological evidence of interstitial pneumonia requiring admission (optional) 5. Informed written consent given

Current exclusion criteria as of 13/05/2021: 1. Patients who require invasive or non-invasive (including CPAP and high flow nasal cannula). ventilation at the time of inclusion 2. AST/ALT values >5 fold the upper normal limit 3. Impairment of renal function( creatinine clearance<30ml/min/m²) 4. Absolute neutrophil count below 500 cells/mm³ 5. Absolute platelet count below 50,000 cells/mm³ 6. Documented sepsis or high clinical suspicion of superimposed severe bacterial or fungal infection 7. Concomitant acute medical emergencies, such as AMI, acute pericarditis, PE, stroke, acute Surgical and orthopaedic emergencies like acute abdomen and fractured neck of femur etc. 8. Comobidities or concomitant medications likely to be incompatible for cotrimoxazole use pregnancy or lactation 9. History of cotrimoxazole hypersensitivity 10. Patients participating in another clinical trial for SARS-CoV-2 infection _____ Previous exclusion criteria: 1. Require invasive or non-invasive (including CPAP and high flow nasal cannula) ventilation at the time of inclusion 2. Aspartate transaminase (AST)/alanine transaminase (ALT) ratio >5 times the ULN 3. Documented impairment of renal function 4. Absolute neutrophil count <500 cells/mm³ 5. Absolute platelet count <50,000 cells/mm³ 6. Documented sepsis or high suspicion of superimposed severe bacterial or fungal infection 7. Comorbidities or concomitant medications likely to be incompatible for cotrimoxazole use 8. Pregnancy or lactation 9. History of cotrimoxazole hypersensitivity 10. Participating in another clinical trial for SARS-CoV-2 infection

2

School of Tropical Medicine; Kolkata

18

65

India

Moderate disease at enrollment

3: Moderate disease at enrollment

200

1.Clinical status; the number of patients requiring escalation of care to non-invasive ventilation (CPAP and HFNC) and invasive ventilation measured using the 7-point ordinal scale (scored from 1 to 7 as follows: 1= death; 2= hospitalised; requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3= hospitalised; requiring non-invasive ventilation or high flow oxygen devices; 4= hospitalised; requiring supplemental oxygen; 5= hospitalised; not requiring supplemental oxygen; but in need of ongoing medical care (COVID-19 related or otherwise); 6= hospitalised; not requiring supplemental oxygen and no longer requires ongoing medical care (independent); or 7= not hospitalised) between baseline and hospital discharge or death 2. Duration of hospitalisation measured from patient records between baseline and hospital discharge or death 3. Number of in-patient deaths measured from patient records between baseline and hospital discharge or death

Not reported

[{"arm_notes": "", "treatment_id": 331, "treatment_name": "Cotrimoxazole", "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"}]