Trial NCT04480957
Publication Low J, medRxiv, 2021
Funding: Private (Arcturus Therapeutics Inc.)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Single center / Singapore Follow-up duration (months): 1.8 | |
1.0 μg ARCT-021 (n = 5) 5.0 μg ARCT-021 (n = 10) 7.5 μg ARCT-021 (n = 10) 10 μg ARCT-021 (n = 5) Placebo (n = 12) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
1 IM dose 5.0 mcg ARCT-021 1 IM dose 1.0 mcg ARCT-021 1 IM dose 7.5 mcg ARCT-021 1 IM dose 10.0 mcg ARCT-021 |
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Control
1 IM dose 0.9% saline | |
Participants | |
Randomized 42 participants | |
Characteristics of participants Type of participants: Adults N=42 29 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 29-51 | |
Description of participants Healthy HIV-negative adults at a single Center in Singapore. | |
Primary outcome | |
In the register Incidence, severity and dose-relationship of AEs [ Time Frame: 56 days ] | |
In the report Local and systemic solicited adverse events (AEs) reported immediately and up to 7 days post-inoculation and unsolicited events reported up to 56 days after inoculation | |
Documents available |
Protocol NR Statistical plan * 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 the pre-print article, the prospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. Phase 1 of the study intended to test single doses of 1.0, 5.0, 10.0, and 20.0 mcg ARCT-21. However, the protocol was amended to remove the 20.0 mcg following a safety review which found that the 10 mcg dose was associated with more local and systemic solicited AEs. A younger (21-55) and older (56-80) 7.5 mcg dose group was added to the study. The study met the target sample size reported in the registry. One pre-stated outcome was not reported in the pre-print (i.e., SARS-CoV-2-specific serum neutralizing antibody seroconversion rate). |