Trial NL9436 (Netherlands Trial Register)
Publication COVID-Compromise - Huygens S, medRxiv (2022) (preprint)
Dates: 2021-04-15 to 2021-07-29
Funding: Mixed (The Netherlands Organisation for Health Research and Development, Sanquin Blood Supply Foundation. Prothya (former Sanquin Plasma Products) generated COVIG and IVIG.)
Conflict of interest: Yes
Methods | |
RCT Blinding: double blinding | |
Location :
Multicenter / Netherlands Follow-up duration (days): 28 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
C-IVIG 15 g infused once-off |
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Control
IV Ig 15 g infused once-off | |
Participants | |
Randomized participants : C-IVIG=10 IV Ig=8 | |
Characteristics of participants N= 18 Mean age : NR 10 males Severity : Mild: n=5 / Moderate: n=13 / Severe: n=0 Critical: n=0 Number of vaccinated participants: 5 | |
Primary outcome | |
In the register More severe course of COVID-19 | |
In the report Occurrence of severe COVID-19 evaluated up until day 28 after treatment. Severe COVID-19 was defined as any of the following: (1) an indication for high-flow nasal oxygen, (2) need for mechanical ventilation, (3) lack of clinical improvement after at least seven days of observation after treatment or (4) readmission for PCR-confirmed COVID-19 within 28 days. | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Not reported |
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 the pre-print article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary in the article broadly reflects that in the registry. The trial (n = 18) did not achieve its target sample size (n = 86) because recruitment was terminated as it was no longer deemed ethically acceptable to withhold casirivimab/imdevimab therapy for patients in the trial. |