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HCQ for Primary Prophylaxis Against COVID19 in Health-care Workers

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ClinicalTrials.gov Identifier: NCT04336748
Recruitment Status : Not yet recruiting
First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Matthias Vossen, Medical University of Vienna

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 0.4) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6464969/) 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 0.3. 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 (https://www.rivm.nl/nieuws/resultaat-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 (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30627-9/fulltext). Several media reports indicate that this proportion is similar across various healthcare institutions and countries (https://www.nytimes.com/2020/03/24/world/europe/coronavirus-europe-covid-19.html) and (https://www.aljazeera.com/news/2020/03/spain-tightens-restrictions-week-lockdown-begins-200330191539568.html).

As the proposed study will be performed in a high-risk setting, we assumed an event (i.e. 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 0.3 with a power of 80.3% with an alpha-error of 0.05. 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.


Condition or disease Intervention/treatment Phase
Sars-CoV2 Infection Viral Healthcare Worker Prophylaxis Drug: Hydroxychloroquine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Low-dose Hydroxychloroquine for Primary Prophylaxis Against SARS-CoV-2 in Health-care Workers - a Randomized, Double-blind, Controlled Trial
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hydroxychloroquine
200mg once daily
Drug: Hydroxychloroquine
low dose (200mg) Hydroxychloroquine once daily for 4 weeks

Placebo Comparator: Placebo Drug: Hydroxychloroquine
low dose (200mg) Hydroxychloroquine once daily for 4 weeks




Primary Outcome Measures :
  1. Symptomatic or asymptomatic SARS-CoV-2 infection confirmed by PCR [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Viral load during SARS-CoV-2 infection [ Time Frame: 4 weeks ]
  2. Seroconversion during the study period [ Time Frame: 4 weeks ]
  3. Incidence of any acute respiratory infection [ Time Frame: 4 weeks ]
  4. Days of sick leave [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health-care worker with frequent contact with confirmed COVID-19 patients
  • No active or past infection with SARS-CoV-2
  • 18 years of age or older
  • No allergy or contraindication to hydroxychloroquine
  • written informed consent

Exclusion Criteria:

  • Age of less than 18 years
  • Pregnancy or lactation
  • unwillingness to use effective contraception during the participation in the trial
  • Use of concomitant medication that prolongs the QT interval
  • Allergy or contraindication to hydroxychloroquine
  • Retinopathy or maculopathy
  • Neuromuscular diseases (i.e Myasthenia gravis, Parkinson's disease)
  • G6PD Deficiency
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Responsible Party: Matthias Vossen, Priv. Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04336748    
Other Study ID Numbers: HCQ prophylaxis for COVID19
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents