Trial NCT04468646
Publication Mehboob R, medRxiv, 2020 (preprint)
Funding: No specific funding (No funding has been received for this study)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Pakistan Follow-up duration (days): 14 | |
| Inclusion criteria | admitted patients above 18 years, both genders, lab confirmed Covid-19 positive
based on PCR, more than 72 hours since the appearance of first symptoms. Patients with moderate to critical stages. |
| Exclusion criteria | Patients with respiratory diseases other than Covid-19 infection and pregnant females were excluded. |
| Interventions | |
| Treatment
Aprepitant+Dexamethasone Aprepitant: 80 mg orally once daily for 3-5 days Dexamethasone: 20 mg |
|
| Control
Dexamethasone (20mg) | |
| Participants | |
| Randomized 41 participants (n1=20 / n2= 21) | |
| Characteristics of participants N=41 Mean age : 52.4 29 males Severity : Mild: n=5 / Moderate: n=20/ Severe: n=8 Critical: n=8 | |
| Primary outcome | |
| In the register Time to improvement on a 7-point ordinal scale as compared to baseline [ Time Frame: 14 days or discharge ] | |
| In the report total in hospital days and the duration of disease | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated 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 |
Some concerns |
| General comment | In addition to all available versions of the pre-print article, the study registry was used in data extraction and risk of bias assessment. This is a report on preliminary results. The target sample size specified in the registry was not achieved. There is no change from the trial registration in the intervention and control treatments. Some secondary outcomes were not reported in the paper. Primary outcome in the registry and report is not the same.On October 10th 2020, we received additional information from authors on this study. |