Aprepitant+Dexamethasone vs Dexamethasone (RCT)

Hospitalized patients

FOREST PLOTS -2021-06-18

Studies description

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+Dex
Aprepitant: 80 mg orally once daily for 3-5 days
Dexamethasone: 20 mg
Control
Dexamethasone
20 mg

Participants
Randomized
participants :
Dexamethasone=21
Aprepitant+Dex=20
Characteristics of participants
N= 41
Mean age : NR
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
avalaible

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:
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.