Ignite Creation Date:
2024-05-06 @ 2:28 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04336748
Status:
WITHDRAWN
Last Update Posted:
2022-04-12
First Post:
2020-04-04
Brief Title:
HCQ for Primary Prophylaxis Against COVID19 in Health-care Workers
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Low-dose Hydroxychloroquine for Primary Prophylaxis Against SARS-CoV-2 in Health-care Workers - a Randomized Double-blind Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not feasible
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Aim To demonstrate the efficacy of low-dose hydroxychloroquine as primary prevention in healthcare workers Design participants and interventions Prospective randomized parallel group double-blinded placebo controlled study
including 440 participants who will be randomised to 2 treatment arms hydroxychloroquine or placebo
Outcome variables symptomatic or asymptomatic SARS-CoV-2 infection confirmed by PCR viral load during SARS-CoV-2 infection seroconversion during the study period incidence of any acute respiratory infection days of sick leave
Statistical considerations No trials have been published investigating the efficacy of HCQ as primary prophylaxis of SARS-CoV-2 infection in health care workers Thus sample size calculations in the proposed trial are based on the investigators best estimates for several parameters
In accordance to the effect of oseltamivir against symptomatic influenza we assumed an approximate effectiveness of approximately 60 HR of 04 httpswwwncbinlmnihgovpmcarticlesPMC6464969 as realistic As a prophylactic intervention with HCQ which may have side effects and for which supply shortage can be expected was judged justifiable only if its effectiveness is high we based our sample size consideration on a HR of 03 To estimate the probability of an event in both the experimental and the control group very little data is available In a Dutch point-prevalence study 0-10 of health-care workers were infected depending on the healthcare institution depending on the hospital This point-prevalence study was performed between 6 and 9 March when the reported number of cases in the Netherlands was 33 and 77 respectively according to the RIVM httpswwwrivmnlnieuwsresultaat-steekproef-4-ziekenhuismedewerkers-heeft-coronavirus Additionally in an a report published in the Lancet 20 of responding healthcare workers in Italy were found to be infected with SARS-CoV2 within less than one month httpswwwthelancetcomjournalslancetarticlePIIS0140-67362030627-9fulltext Several media reports indicate that this proportion is similar across various healthcare institutions and countries httpswwwnytimescom20200324worldeuropecoronavirus-europe-covid-19html and httpswwwaljazeeracomnews202003spain-tightens-restrictions-week-lockdown-begins-200330191539568html
As the proposed study will be performed in a high-risk setting we assumed an event ie PCR positivity probability of 10 in the control group and 3 in the experimental arm after the maximum study period In summary a sample size of 210 participants per arm is necessary to detect a HR of 03 with a power of 803 with an alpha-error of 005 To account for drop-outs and asymptomatic undetected infection at inclusion or past infection with existing immunity an additional 10 participants will randomized per treatment arm The overall study population is therefore 440 participants
Statistical analysis will be based on two populations A Modified Intention to Treat population excluding those who withdrew consent after randomization and those with a positive serology at baseline And a per protocol population including all randomized subjects who completed at least 3 out of 4 follow-up visits and took at least 80 of all doses of study medication
Aim To demonstrate the efficacy of low-dose hydroxychloroquine as primary prevention in healthcare workers Design participants and interventions Prospective randomized parallel group double-blinded placebo controlled study
including 440 participants who will be randomised to 2 treatment arms hydroxychloroquine or placebo
Outcome variables symptomatic or asymptomatic SARS-CoV-2 infection confirmed by PCR viral load during SARS-CoV-2 infection seroconversion during the study period incidence of any acute respiratory infection days of sick leave
Statistical considerations No trials have been published investigating the efficacy of HCQ as primary prophylaxis of SARS-CoV-2 infection in health care workers Thus sample size calculations in the proposed trial are based on the investigators best estimates for several parameters
In accordance to the effect of oseltamivir against symptomatic influenza we assumed an approximate effectiveness of approximately 60 HR of 04 httpswwwncbinlmnihgovpmcarticlesPMC6464969 as realistic As a prophylactic intervention with HCQ which may have side effects and for which supply shortage can be expected was judged justifiable only if its effectiveness is high we based our sample size consideration on a HR of 03 To estimate the probability of an event in both the experimental and the control group very little data is available In a Dutch point-prevalence study 0-10 of health-care workers were infected depending on the healthcare institution depending on the hospital This point-prevalence study was performed between 6 and 9 March when the reported number of cases in the Netherlands was 33 and 77 respectively according to the RIVM httpswwwrivmnlnieuwsresultaat-steekproef-4-ziekenhuismedewerkers-heeft-coronavirus Additionally in an a report published in the Lancet 20 of responding healthcare workers in Italy were found to be infected with SARS-CoV2 within less than one month httpswwwthelancetcomjournalslancetarticlePIIS0140-67362030627-9fulltext Several media reports indicate that this proportion is similar across various healthcare institutions and countries httpswwwnytimescom20200324worldeuropecoronavirus-europe-covid-19html and httpswwwaljazeeracomnews202003spain-tightens-restrictions-week-lockdown-begins-200330191539568html
As the proposed study will be performed in a high-risk setting we assumed an event ie PCR positivity probability of 10 in the control group and 3 in the experimental arm after the maximum study period In summary a sample size of 210 participants per arm is necessary to detect a HR of 03 with a power of 803 with an alpha-error of 005 To account for drop-outs and asymptomatic undetected infection at inclusion or past infection with existing immunity an additional 10 participants will randomized per treatment arm The overall study population is therefore 440 participants
Statistical analysis will be based on two populations A Modified Intention to Treat population excluding those who withdrew consent after randomization and those with a positive serology at baseline And a per protocol population including all randomized subjects who completed at least 3 out of 4 follow-up visits and took at least 80 of all doses of study medication
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None