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): 2.8 | |
3.0 mcg ARCT-021 (n = 24) 5.0 mcg ARCT-021 (n = 24) Placebo (n = 16) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
2 IM doses 3.0 mcg ARCT-021 28 days apart 2 IM doses 5.0 mcg ARCT-021 28 days apart |
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Control
2 IM doses 0.9% saline placebo 28 days apart | |
Participants | |
Randomized 64 participants | |
Characteristics of participants Type of participants: Adults N=64 49 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 22-68 | |
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. 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). The trial registry does not clearly report the doses administered to each vaccine arm in Phase 2 of the trial. |