Trial NCT04652102; EudraCT 2020-003998-22
Publication Kremsner P, Lancet Infect Dis, 2022
Dates: 2020-12-11 to 2021-04-12
Funding: Mixed (The German Federal Ministry of Education and Research (BMBF), CureVac AG)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Multicenter / Belgium, Germany, The Netherlands, Spain, Argentina, Colombia, Dominican Republic, Mexico, Panama, Peru Follow-up duration (months): 6.23 | |
12 mcg CVnCoV (n=19846) Placebo (n=19834) | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
2 IM doses of 12 mcg, 28 days apart |
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Control
2 IM doses, 28 days apart | |
Participants | |
Randomized 39680 participants | |
Characteristics of participants Type of participants: Adults N=39680 21672 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 18-98 | |
Description of participants Adults with no history of COVID-19 in 47 centers in Belgium, Germany, The Netherlands, Spain, Argentina, Colombia, Dominican Republic, Mexico, Panama and Peru | |
Primary outcome | |
In the register 1. Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity [ Time Frame: Day 1 to Day 393 ]; 2. Number of participants who experience one or more medically-attended adverse events (AEs) [ Time Frame: Day 29 to Day 211 ]; 3. Intensity grading of medically-attended adverse events (AEs) per FDA toxicity grading scale [ Time Frame: Day 29 to Day 211 ]; 4. Number of participants who experience one or more treatment-related medically-attended adverse events (AEs) [ Time Frame: Day 29 to Day 211 ]; 5. Number of participants who experience one or more serious adverse events (SAEs) [ Time Frame: Day 29 to Day 393 ]; 6. Intensity grading of serious adverse events (SAEs) per FDA toxicity grading scale [ Time Frame: Day 29 to Day 393 ]; 7. Number of participants who experience one or more treatment-related serious adverse events (SAEs) [ Time Frame: Day 29 to Day 393 ]; 8. Number of participants who experience one or more adverse events of special interest (AESI) [ Time Frame: Day 29 to Day 393 ]; 9. Intensity grading of adverse events of special interest (AESI) per FDA toxicity grading scale [ Time Frame: Day 29 to Day 393 ]; 10. Number of participants who experience one or more treatment-related adverse events of special interest (AESI) [ Time Frame: Day 29 to Day 393 ]; 11. Number of participants who experience a fatal serious adverse event (SAE) [ Time Frame: Day 29 to Day 393 ] | |
In the report The occurrence of a first episode of virologically confirmed symptomatic COVID-19 of any severity and caused by any strain from 15 days after the second dose up to 1 year. | |
Documents available |
Protocol NR Statistical plan * Data-sharing stated:
Yes, From when the trial is complete for a minimum of five years from the end of the trial |
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 published article, the prospective registry and the supplementary material were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. Follow-up is ongoing, the cut-off date for this analysis was 18 June 2021. In this report the primary outcome broadly reflects that in the protocol, except that in the registry the timeframe for a first episode of virologically-confirmed COVID-19 is Day 1 to Day 393 whereas in the report this is from two weeks after the second dose. The study achieved its modified event-driven target sample size. The number analyzed for COVID events was substantially reduced because participants were allowed to be unblinded when they became eligible for a licensed vaccine and were subsequently excluded from efficacy analyses. This trial was updated on Mar 3rd, 2022 after publication of the study report. |