COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53532

Dr Bharti Wadhwa

drbhartitaneja@gmail.com

2021-03-04

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Confirmed COVID-19 by RT PCR test <br/ >Hospitalized Non ventilated patients with oxygen by mask or nasal prongs (WHO <br/ >Ordinal Scale 4: Appendix 1) <br/ >SpO2 < 94% on room air but maintaining SpO2 of >94% on VenturiMask / Non <br/ >rebreathing mask <br/ >

Participation in another clinical trial of an investigational medicinal product <br/ > Known hypersensitivity to the IMP <br/ >Significant electrolyte disturbance (Hyperkalemia: K+ >5.0 mmol/L) <br/ >Patient currently receiving potassium sparing diuretics that cannot be reasonably <br/ >withheld <br/ >â?¢ Acute renal insufficiency <br/ >â?¢ In the Investigatorâ??s opinion, patient is unwilling or unable to comply with drug <br/ >administration plan, laboratory tests or other study procedures. <br/ >â?¢ Pregnant or lactating patient <br/ >â?¢ Patients on the following drugs : ACE inhibitors, Amiloride, Hydrocortisone, <br/ >Prednisolone, Methylprednisolone, Triamterene

2

None

18

85

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

120

1.The time to recover; defined as the first day; during the 28 days after enrollment; on which a patient met the criteria for category 1;2; 0r 3 WHO ordinal scale. <br/ >2.To determine the effect of the medication on Von Willebrand Factor; Angiotensin II; aldosterone and D-Dimer Levels.Timepoint: Baseline <br/ >Day 1 <br/ >Day 4 <br/ >Day 7

| Declared number of arm (5.0) differs from found arms (6.0)

Not reported

[{"arm_notes": "50mg on day 1 followed by 25mg till day 21", "treatment_id": 1228, "treatment_name": "Spironolactone", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "6mg only for ten days", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]