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
Blinding: single blinding
Single center / India |
Follow-up duration (days): 28
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.
3 mg orally twice daily for 10 days.
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
|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.
Data-sharing willing stated in the publication:
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|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 Mortality and serious adverse events were not reported; those with clinical deterioration were withdrawn from the trial and not followed up.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.|