Trial IRCT20200501047259N1
Publication Gharebaghi N, BMC Infect Dis (2020) (published paper)
Dates: 2020-05-09 to 2020-06-09
Funding: Public/non profit (Urmia University of Medical Sciences)
Conflict of interest: No
Methods | |
RCT Blinding: double blinding | |
Location :
Single center / Iran Follow-up duration (days): * | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
IV Ig 5 g IV four times a day for 3 consecutive days |
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Control
Placebo | |
Participants | |
Randomized participants : IV Ig=30 Placebo=29 | |
Characteristics of participants N= 59 Mean age : NR 41 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=* Critical: n=* Number of vaccinated participants: NR | |
Primary outcome | |
In the register Increasing of patient's O2 saturation above 90%, improvement of lung involvement in lung CT scan | |
In the report In-hospital mortality | |
Documents available |
Protocol NR Statistical plan NR Data-sharing willing stated in the publication:
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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 |
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General comment |
This study is pending author reply. The timepoints for outcomes were not reported.
In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size reported in the registry. There is no change from the trial registration in the intervention and control treatments. Safety analysis was not performed. |