Covid-19 Living Data

Trial CTRI/2021/03/031721
Publication Wadhwa B, medRxiv (2022) (preprint)
Dates: 2021-02-01 to 2021-04-30
Funding: Public/non profit (The trial in India was supported by the MAMC and the UK investigators were supported by the STOPCOVID project that has received a grant from LifeArc, an independent medical research charity.)
Conflict of interest: No

Methods
	RCT Blinding: single blinding
	Location : Single center / India Follow-up duration (days): 28
Inclusion criteria	Positive nasopharyngeal SARS-CoV-2 polymerase chain reaction (PCR) and/or had chest radiographic changes consistent with COVID-19 pneumonia with an additional oxygen requirement (oxygen saturations (SpO2) <94 % on room air but maintaining SpO2 of > 94 % on supplemental oxygen by mask or nasal prongs) aged 18-85 years Hospitalized Non-ventilated patients (WHO Ordinal Scale 4).
Exclusion criteria	Participation in another clinical trial of an investigational medicinal product (IMP) mechanical ventilation known hypersensitivity to the IMP significant electrolyte disturbance (Hyperkalaemia: K+ >5.5 mmol/L) receiving potassium sparing diuretics that could not be reasonably withheld acute renal insufficiency if in the investigator’s opinion the patient was unwilling or unable to comply with drug administration plan required laboratory tests or other trial procedures pregnancy or lactating if the patient was on the following drugs: ACE inhibitors, amiloride, hydrocortisone, prednisolone, methylprednisolone, triamterene.
Interventions
	Treatment Spironolactone+DEX Spironolactone- Initial dose: 50 mg orally once daily on day 1 -Maintenance dose: 25 mg orally once daily until day 21. Dexamethasone: 3 mg orally twice daily for 10 days.
	Control Dexamethasone 3 mg orally twice daily for 10 days.
Participants
	Randomized participants : Spironolactone+DEX=74 Dexamethasone=46
	Characteristics of participants N= 120 Mean age : NR 74 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register 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, or 3 WHO ordinal scale. 2. To determine the effect of the medication on Von Willebrand Factor, Angiotensin II, aldosterone and D-Dimer Levels. Timepoints: Baseline, Day 1, Day 4, Day 7.
	In the report 1. time to recovery, (as defined as the first day after enrolment, where the patient met the criteria of WHO OS score ≤3); and 2. circulating Von Willebrand Factor (VWF), angiotensin II, aldosterone, and D-dimer levels taken at baseline, day 4 and day 7.
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	High
General comment	In addition to the preprint, the retrospective study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Mortality and serious adverse events were not reported; those with clinical deterioration were withdrawn from the trial and not followed up. The study was assessed to be at a high risk of bias due to concerns in multiple domains and because data was missing for a substantial proportion of participants, unequal proportions of whom were excluded from further participation due to clinical worsening.