COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=65183

Dr Shweta A Singh

drshwetasingh29@gmail.com

2022-01-28

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Adult male or female patients, with proven COVID-19 moderate disease with any one of respiratory rate 24- 30/min, breathlessness, SPO2 90-93% on room air will be included in the study.

(a) Children < 18 years of age, age >70 years <br/ > (b) Pregnancy & lactation <br/ > (c) History of GI bleeding <br/ > (d) History of Seizures, Cardiac or other vascular stents <br/ > (e) History of intracranial hemorrhage <br/ > (f) Patients with recent cerebral and/or retinal hemorrhage/ intracranial haemorrhage <br/ > (g) Pts with serum ALT/AST > 5 times the upper limit of normal <br/ > (h) In patients who have previously exhibited intolerance to this product <br/ >

2

Dr Subhash Gupta

18

70

India

Moderate disease at enrollment

3: Moderate disease at enrollment

194

we will evaluate the impact of addition of tablet Pentoxifylline to conventional treatment in patients with moderate COVID -19 disease on reduction in need for invasive ventilation (IV) i.e. intubation and mechanical ventilation. <br/ >Lesser number of patients with moderate COVID disease on WHO ordinal scale 4 ( i.e those who require oxygen therapy through face mask/ nasal prongs) would deteriorate to WHO Ordinal scale 6 (i.e. those needing intubation and mechanical ventilation)Timepoint: 28 days

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

Phase 2

[{"arm_notes": "", "treatment_id": 971, "treatment_name": "Pentoxifylline", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]