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PRevention of COVID-19 With Oral Vitamin D Supplemental Therapy in Essential healthCare Teams (PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04483635
Recruitment Status : Not yet recruiting
First Posted : July 23, 2020
Last Update Posted : November 23, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Laboratoire RIVA
Information provided by (Responsible Party):
Professor Francine Ducharme, St. Justine's Hospital

Tracking Information
First Submitted Date  ICMJE June 29, 2020
First Posted Date  ICMJE July 23, 2020
Last Update Posted Date November 23, 2020
Estimated Study Start Date  ICMJE November 30, 2020
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2020)
Change in incidence of laboratory-confirmed COVID-19 infection [ Time Frame: 16 weeks ]
documented by salivary or NP samples obtained clinically for screening or diagnostic purposes throughout the study period, self-obtained salivary samples at endpoint, analysed by RT-qPCR or COVID-19 seroconversion at endpoints
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2020)
Change in incidence of laboratory-confirmed COVID-19 infection [ Time Frame: up to 16 weeks ]
self-obtained mid-turbinate nasopharyngeal (NP) swabs analysed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test (NAAT), following standard operating procedures certified by the Quebec Public Health Laboratory of the National Public Health Institute (complemented by NP swabs obtained clinically for screening or diagnostic purposes analyzed using the same technique.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2020)
  • Distribution of disease severity [ Time Frame: up to 16 weeks ]
    5-category ordinal variable [asymptomatic, mild (managed at home); moderate (hospitalisation without supplemental oxygen; severe (oxygen supplementation); critical (mechanical ventilation/death)
  • Duration of symptoms in COVID-19 positive participants [ Time Frame: up to 16 weeks ]
    For asymptomatic positive COVID-19 participants, symptoms will be recorded in a daily diary up to 14 days. Symptomatic positive COVID-19 participants will record their symptoms in a daily diary up to 48 hours after the resolution of symptoms
  • Number of participants with COVID-19 positive IgG serology [ Time Frame: 16 weeks ]
    SARS-CoV-2 IgG Diasorin on Liaison XL platform
  • Number of workday absences due to COVID-19 suspected/confirmed infection [ Time Frame: 16 weeks ]
    Participant-reported; reported by Direction of Human Resource (or for physicians, Direction des services professionnelles) databases
  • Number of workday absences for any reason [ Time Frame: 16 weeks ]
    Participant-reported; reported by Direction of Human Resource (or for physicians, Direction des services professionnelles) databases
  • Adverse health events [ Time Frame: 16 weeks ]
    Number and distribution of adverse health events
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2020)
  • Distribution of disease severity [ Time Frame: up to 16 weeks ]
    5-category ordinal variable [asymptomatic, mild (managed at home); moderate (hospitalisation without supplemental oxygen; severe (oxygen supplementation); critical (mechanical ventilation/death)
  • Duration of COVID-19 positivity [ Time Frame: up to 16 weeks ]
    Duration of COVID+ test: that is, between first COVID+ test to first COVID- test
  • Number of participants with COVID-19 positive IgG serology [ Time Frame: up to 16 weeks ]
    SARS-CoV-2 IgG Diasorin on Liaison XL platform
  • Number of workday absences due to COVID-19 suspected/confirmed infection [ Time Frame: up to 16 weeks ]
    Participant-reported; reported by Direction of Human Resource (or for physicians, Direction des services professionnelles) databases
  • Number of workday absences for any reason [ Time Frame: up to 16 weeks ]
    Participant-reported; reported by Direction of Human Resource (or for physicians, Direction des services professionnelles) databases
  • Changes in adverse health events [ Time Frame: up to 16 weeks ]
    Number and distribution of adverse health events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRevention of COVID-19 With Oral Vitamin D Supplemental Therapy in Essential healthCare Teams
Official Title  ICMJE PROTECT RCT (PRevention of COVID-19 With Oral Vitamin D Supplemental Therapy in Essential healthCare Teams
Brief Summary In this 16-week randomized control study, health care workers will receive a bolus dose followed by a weekly dose of vitamin D or a placebo bolus and weekly dose. This study will test whether high-dose of vitamin D supplementation decreases the incidence of laboratory-confirmed COVID19 infection (primary outcome), reduces illness severity, duration, as well as work absenteeism among health care workers (HCW) in setting at high-risk of contact with COVID-19 cases in high COVID-19 incidence areas.
Detailed Description

Design. A 16-week triple-blind, placebo-controlled parallel-group, randomised trial of high-dose vitamin D supplementation compared to placebo in health care workers (HCW).

Subjects: HCW caring for individuals at high-risk of infection (i.e., COVID-suspected or confirmed cases) will be randomly allocated in a 1:1 ratio in variable block size to: Intervention-1 oral loading dose of 100,000 IU vitamin D3 + 10000 IU weekly vitamin D3 or Control-identical placebo loading dose + daily placebo. Follow-up: 2 (randomisation and end-of-study) virtual or in-person visits with weekly reminders, brief health and work-status questionnaire, and repeated salivary (or nasopharyngeal) samples.

Randomisation/allocation concealment: Randomisation will be implemented using a computer-generated random list stratified by regions; health care workers will be allocated (1:1) using permuted block randomisation to enhance concealment.

Sample size: A total of 2414 healthcare workers will provide 80% power to detect a 20% reduction in the risk of laboratory-confirmed COVID-19 infection. Given uncertainties in the infection progression, a Bayesian adaptive design is used where the posterior probability of effectiveness is the basis of inference and decision making, for study continuation or termination.

Procedures. Use of remote or in-person randomisation and/or end-of-study visits and remote documentation of outcomes via electronic communication, mailing of biological samples, and external databases will facilitate enrolment, monitoring, and retention of motivated HCW in this high-intensity trial.

Data analyses: An intention-to-treat analysis will be carried out on all randomized participants. Efficacy and safety analyses will be performed under allocation concealment with unblinding occurring after trial completion and analysis of primary outcomes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel-group, placebo controlled trial of vitamin D3 supplementation
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The Laboratoires Riva will provide the active vitamin D3 and placebo pills, identical in appearance, which will be pre-packaged in coded 60-pill bottles. A web-based randomisation system will allow the research personnel (RP) to log in, obtain a randomization number, and dispense study drugs, pre-prepared by the Central pharmacy, in masked kits.
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Dietary Supplement: Placebo
    Weekly oral dose of placebo
  • Dietary Supplement: Vitamin D
    Weekly oral dose of Vitamin D
    Other Name: cholecalciferol
Study Arms  ICMJE
  • Placebo Comparator: Placebo

    10 placebo tablets taken orally at baseline, followed by 1 placebo tablet once a week for 16 weeks

    Note that the study may be prolonged according to the overall infection rate monitored monthly.

    Intervention: Dietary Supplement: Placebo
  • Experimental: Vitamin D3

    10 tablets containing 10,000 IU (total : 100,000 IU) of Vitamin D3 taken orally at baseline, followed by 10,000 IU once a week for 16 weeks.

    Note that the study may be prolonged according to the overall infection rate monitored monthly.

    Intervention: Dietary Supplement: Vitamin D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 21, 2020)
2414
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • are aged ≥18 and <70 years old;
  • licenced to practice in Quebec;
  • working or scheduled to work over the next 16 weeks in a setting at high-risk of contact with COVID-19 cases, particularly (but not only) those involved with aerosol generating medical procedures in hospitals and caring for patients with no negative pressure room (LTCF);
  • working in high COVID incidence areas;
  • covered by the RAMQ for medical services and hospitalisations;
  • has a personal email or phone (to which to send every two weeks a reminder and questionnaire by email or text messages);
  • has a fixed address (to which to send the material) in the greater Montreal or surrounding areas.

Exclusion Criteria:

  • vitamin D supplementation ≥400 IU/day or ≥ 12,000 IU/month in past 3 months;
  • suspected or previously documented COVID-19 infection;
  • history of nephrolithiasis, hypercalcemia, hyperphosphatemia, hyperparathyroidism, granulomatosis disease (e.g., tuberculosis, sarcoidosis), renal impairment/failure, active cancer, or malabsorption syndromes;
  • use of any of the following medications: lithium, thiazide or thiazide-like medication, tamoxifen, amiloride, teriparatide, theophyllin, or digoxin;
  • anticipated prolonged absence from work during the study period (i.e., pregnancy);
  • enrolment in a concurrent randomized trial;
  • has received a vaccine against COVID-19.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Natacha Gaulin-Marion 514-345-4931 ext 7243 anatacha.gaulin-marion.hsj@ssss.gouv.qc.ca
Contact: Amandine Augé 514-345-4931 ext 6196 Amandine.Auge1.hsj@ssss.gouv.qc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04483635
Other Study ID Numbers  ICMJE MP-21-2021-3044
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Francine Ducharme, St. Justine's Hospital
Study Sponsor  ICMJE St. Justine's Hospital
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Laboratoire RIVA
Investigators  ICMJE
Principal Investigator: Francine M Ducharme, MD St. Justine's Hospital
Principal Investigator: Cecile Tremblay, MD CHUM
PRS Account St. Justine's Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP