Trial *
Publication Borges M, Revista Universidad,, 2021 (published paper)
Dates: 2020-03-01 to 2020-04-30
Funding: Not reported/unclear
Conflict of interest: *
| Methods | |
| RCT | |
| Location :
* / Ecuador Follow-up duration (days): 42 | |
| Inclusion criteria | Adults and children with signs and symptoms of SARS-CoV-2 and o2 saturation >90% at room air; controlled comorbidities; less than 15 days since symptoms appearance. |
| Exclusion criteria | NR |
| Interventions | |
| Treatment
Methisoprinol Children: 50 mg/kg orally divided in four daily doses for 4 days; 50 mg/kg orally divided in three daily doses for 10 days Adults: Initial single dose of 1 g orally; 500 mg four times daily for 4 days; 500 mg three times daily for 14 days |
|
| Control
Standard care ( / ) Definition of Standard care: Children: Azithromycin 10mg /kg /day orally for 5 days AND amoxicillin + clavulanic acid 25mg/kg/day orally divided in two daily doses for 7 days AND dexamethasone 0.4mg/kg /day intramuscular for 3 days, rotating to prednisone 1mg/kg/day for seven days AND ascorbic acid 20mg/kg/day orally for 14 days Adults: Azithromycin 500mg orally once daily for 5 days AND amoxicillin + clavulanic acid 1g orally twice per day for 7 days AND dexamethasone initial single dose 16 mg IV then 8mg intramuscular once daily for 3 day rotating to prednisone 25mg orally twice per day decreasing to a pyramidal dose for 7 days AND ascorbic acid 1.5gr orally twice per day for 14 days | |
| Participants | |
| Randomized 60 participants (n1=30 / n2= 30) | |
| Characteristics of participants N=60 Mean age : NR * males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register NR | |
| In the report NR | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated NR |
| 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 |
* |
| General comment | This study was developed to determine a pilot protocol that generates fewer adverse effects, avoiding medical complications in symptomatic patients and reverse the clinical and imaging picture in patients treated with metisoprinol compared to controls. No study registry or protocol available. Published article with limited data to extract baseline characteristics/co-interventions per study arm, and to assess the overall risk of bias.Outcomes reported were no relevant for the COVID-19 NMA. Consequently, no outcome data have been extracted for this study. |