Trial NCT04591600
Publication Hashim A, medRxiv (2020) (preprint)
Dates: 2020-07-01 to 2020-09-30
Funding: Public/non profit (Baghdad-Alkarkh General Directorate of Health in Bghadad, Iraq)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Iraq Follow-up duration (days): 56 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
IVM+DX IVM: 200 mcg/kg/day PO for 2 days, third dose 7 days after the first, as needed; DX: 100 mg PO every 12 hrs for 5-10 days |
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Control
Standard care | |
Participants | |
Randomized NR Analyzed 140 participants IVM+DX=70 Standard care=70 | |
Characteristics of participants N= 140 Mean age : NR 73 males Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=* Number of vaccinated participants: NR | |
Primary outcome | |
In the register 1. Mortality rate [ Time Frame: Up to 8 weeks ] The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients. 2. Rate of progression disease [ Time Frame: up to 8 weeks ] Rate of patients under treatment who undergo progression of disease to a more advanced stage | |
In the report NR | |
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 all available versions of the pre-print, the study register was used in data extraction and risk of bias assessment. No sample size calculation was reported. The study used quasi-randomized allocation, with participants allocated to treatments according to their day of recruitment; this method was compromised in that all critical patients were allocated to the experimental treatment arm, reported as being for ethical reasons. The type of blinding extracted for the study was based on the registry as no information was stated in the report regarding this. There was also no primary or secondary outcomes reported in the paper, nor a flow chart or explicit mention of the absolute number of patients randomized per arm. |