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Hydroxychloroquine Chemoprophylaxis for COVID-19 Infection in High-risk Healthcare Workers.

Primary Purpose

SARS-CoV-2, Healthcare Workers

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebo oral tablet
Sponsored by
Services Institute of Medical Sciences, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV-2 focused on measuring SARS-CoV-2, HCQ, prophylaxis, healthcare workers

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult healthcare workers all genders ≥ 18 to ≤ 60 years of age upon study consent.

  • Healthcare workers (doctors and nurses) at Services hospital, Lahore considered work at high-risk of SARS-CoV-2 exposure (defined below):

    • Healthcare workers in Corona triage areas.
    • Healthcare workers in Corona Isolation Units.
    • Healthcare workers in Corona ICUs.
    • Healthcare workers in general medical wards.
    • Healthcare workers in general surgical wards.
    • Healthcare workers in other units not directly dealing with suspected Corona patients e.g. Endocrinology department
  • Afebrile with no constitutional symptoms.
  • No household contact with confirmed active SARS-CoV-2 infection in the last 3 weeks.
  • Negative PCR at visit 0.
  • Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
  • Willing to not take any other medicines especially fluoroquinolones and macrolides for the duration of study.
  • Signed informed consent, demonstrating that the subject understands the interventions required for the study and the purpose of the study.

Exclusion Criteria:

  • Participation in other investigational clinical trials for the treatment or prevention of SARS-CoV-2 infection within 30days.
  • Subjects unwilling to practice at least one highly effective method of birth control for the duration of the study.
  • Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia or prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
  • Having H/O skin disorders e.g. dermatitis, psoriasis or porphyria.

  • Taking any of the following medication:

    • Anti-arrythmic agents including digoxin.
    • GI drugs including antacids, proton-pump inhibitors, cimetidine.
    • Anti-cancer treatment including methotrexate, cyclosporin.
    • Anti-diabetic agents including insulin.
    • Corticosteroids.
    • Drugs causing QT interval prolongation especially antidepressants, anti-epileptics and macrolides.
    • Drugs affecting electrolyte balance including diuretics, laxatives.
    • Drug allergies: 4-Aminoquinolines.
  • Pre-existing retinopathy/maculopathy of the eye.
  • Known chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis.
  • Previous history of severe hypoglycaemia.
  • Known case of renal disease.
  • Untreated or uncontrolled active bacterial, fungal infection.
  • Known or suspected active drug or alcohol abuse.
  • Women who are pregnant or breastfeeding.
  • Known hypersensitivity to any component of the study drug.
  • A known history of prolonged QT syndrome or history of additional risk factors for arrythmias (e.g., heart failure, family history of Long QT Syndrome).
  • Known H/O respiratory disorders e.g. asthma, chronic obstructive pulmonary disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Treatment group

    Control group

    Arm Description

    Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with oral hydroxychloroquine 400 mg twice a day (four 200 mg tablets) on day 1 followed by 400mg (two 200 mg tablets) once a week for 11 weeks.

    Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with placebo twice a day (four tablets) on day 1 followed by 2 tablets once a week for 11weeks.

    Outcomes

    Primary Outcome Measures

    Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period
    Negative RT-PCR for SARS-CoV-2 both at baseline and at end of 12 weeks in experimental arm
    Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment
    To assess the presence or absence of side effects from HCQ treatment.

    Secondary Outcome Measures

    Confirmed SARS-CoV-2 infection based on symptoms and confirmed by RT-PCR
    Symptomatic infection by SARS-CoV-2 defined as cough, dyspnea, fever, myalgia, arthralgia or rhinorrhea.
    Clinical disease severity in confirmed SARS-CoV-2 participants
    Disease severity including i) asymptomatic. ii) Mild symptoms but ambulatory. iii) Moderate symptoms requiring hospitalisation. iv) severe symptoms requiring ICU care and oxygen. v) Severe symptoms requiring assisted mechanical ventilation. vi) Death.
    Incidence of any acute respiratory infection
    Symptomatic non-COVID viral infection (any other acute respiratory illness with fever but without evidence of epidemiological risk factors such as close contact with SARS-CoV-2 positive patient or travel to or residence in high-risk area).

    Full Information

    First Posted
    April 27, 2020
    Last Updated
    May 4, 2020
    Sponsor
    Services Institute of Medical Sciences, Pakistan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04370015
    Brief Title
    Hydroxychloroquine Chemoprophylaxis for COVID-19 Infection in High-risk Healthcare Workers.
    Official Title
    Efficacy and Safety of Hydroxychloroquine in Primary Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers at Risk of Exposure: Randomised Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 15, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2020 (Anticipated)
    Study Completion Date
    October 15, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Services Institute of Medical Sciences, Pakistan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. There are in vitro studies available which show inhibition of corona virus by hydroxychloroquine, a widely-used agent against malaria and certain autoimmune conditions and of low-cost and limited toxicity. However, evidence regarding its effects in patients is limited. We plan to conduct a randomized controlled trial to evaluate the safety and potential prophylactic efficacy of hydroxychloroquine in preventing secondary SARS-CoV-2 infection among healthcare workers at high-risk of exposure while managing such patients.
    Detailed Description
    An interventional randomised control trial that will include 374 participants who will be healthcare workers at variable risks of exposure to SARS-CoV-2 while managing patients both suspected and confirmed with COVID-19 infection.Each participant will undergo detailed clinical evaluation to confirm eligibility, complete blood count, retinal imaging and ECG rhythm lead at baseline. A nasopharyngeal swab for reverse-transcriptase-polymerase chain reaction (RT-PCR) will also be taken. The enrolled participants will be randomised to two treatment arms with the experimental arm receiving Tab.Hydroxychloroquine (HCQ) 400mg twice a day on day 1 followed by 400mg weekly for 11 weeks. The placebo comparator arm will receive 2 tablets twice daily on day 1 followed by 2 tablets weekly for 11 weeks. The participants will be followed up via phone call weekly to ensure drug compliance, occurrence of drug-related side effects or respiratory symptoms. The final visit 4 will mark the end of study at 12 weeks from randomisation when a repeat nasopharyngeal swab for SARS-CoV-2 RT-PCR will be taken.The primary outcome measures will be prevention of SARS-CoV-2 infection as determined by a negative RT-PCR in the experimental arm at the end of 12 weeks and HCQ safety as determined by occurrence of adverse events.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SARS-CoV-2, Healthcare Workers
    Keywords
    SARS-CoV-2, HCQ, prophylaxis, healthcare workers

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    parallel assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Double blinding
    Allocation
    Randomized
    Enrollment
    374 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group
    Arm Type
    Experimental
    Arm Description
    Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with oral hydroxychloroquine 400 mg twice a day (four 200 mg tablets) on day 1 followed by 400mg (two 200 mg tablets) once a week for 11 weeks.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with placebo twice a day (four tablets) on day 1 followed by 2 tablets once a week for 11weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxychloroquine
    Other Intervention Name(s)
    HCQ
    Intervention Description
    Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with oral hydroxychloroquine 400 mg twice a day (four 200 mg tablets) on day 1 followed by 400mg (two 200 mg tablets) once a week for 11 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo oral tablet
    Intervention Description
    • Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with placebo twice a day (four tablets) on day 1 followed by 2 tablets once a week for 11weeks.
    Primary Outcome Measure Information:
    Title
    Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period
    Description
    Negative RT-PCR for SARS-CoV-2 both at baseline and at end of 12 weeks in experimental arm
    Time Frame
    From date of randomization until study completion 12 weeks after treatment initiation
    Title
    Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment
    Description
    To assess the presence or absence of side effects from HCQ treatment.
    Time Frame
    From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
    Secondary Outcome Measure Information:
    Title
    Confirmed SARS-CoV-2 infection based on symptoms and confirmed by RT-PCR
    Description
    Symptomatic infection by SARS-CoV-2 defined as cough, dyspnea, fever, myalgia, arthralgia or rhinorrhea.
    Time Frame
    From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
    Title
    Clinical disease severity in confirmed SARS-CoV-2 participants
    Description
    Disease severity including i) asymptomatic. ii) Mild symptoms but ambulatory. iii) Moderate symptoms requiring hospitalisation. iv) severe symptoms requiring ICU care and oxygen. v) Severe symptoms requiring assisted mechanical ventilation. vi) Death.
    Time Frame
    From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
    Title
    Incidence of any acute respiratory infection
    Description
    Symptomatic non-COVID viral infection (any other acute respiratory illness with fever but without evidence of epidemiological risk factors such as close contact with SARS-CoV-2 positive patient or travel to or residence in high-risk area).
    Time Frame
    From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult healthcare workers all genders ≥ 18 to ≤ 60 years of age upon study consent. Healthcare workers (doctors and nurses) at Services hospital, Lahore considered work at high-risk of SARS-CoV-2 exposure (defined below): Healthcare workers in Corona triage areas. Healthcare workers in Corona Isolation Units. Healthcare workers in Corona ICUs. Healthcare workers in general medical wards. Healthcare workers in general surgical wards. Healthcare workers in other units not directly dealing with suspected Corona patients e.g. Endocrinology department Afebrile with no constitutional symptoms. No household contact with confirmed active SARS-CoV-2 infection in the last 3 weeks. Negative PCR at visit 0. Willing and able to comply with scheduled visits, treatment plan, and other study procedures. Willing to not take any other medicines especially fluoroquinolones and macrolides for the duration of study. Signed informed consent, demonstrating that the subject understands the interventions required for the study and the purpose of the study. Exclusion Criteria: Participation in other investigational clinical trials for the treatment or prevention of SARS-CoV-2 infection within 30days. Subjects unwilling to practice at least one highly effective method of birth control for the duration of the study. Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia or prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. Having H/O skin disorders e.g. dermatitis, psoriasis or porphyria. Taking any of the following medication: Anti-arrythmic agents including digoxin. GI drugs including antacids, proton-pump inhibitors, cimetidine. Anti-cancer treatment including methotrexate, cyclosporin. Anti-diabetic agents including insulin. Corticosteroids. Drugs causing QT interval prolongation especially antidepressants, anti-epileptics and macrolides. Drugs affecting electrolyte balance including diuretics, laxatives. Drug allergies: 4-Aminoquinolines. Pre-existing retinopathy/maculopathy of the eye. Known chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis. Previous history of severe hypoglycaemia. Known case of renal disease. Untreated or uncontrolled active bacterial, fungal infection. Known or suspected active drug or alcohol abuse. Women who are pregnant or breastfeeding. Known hypersensitivity to any component of the study drug. A known history of prolonged QT syndrome or history of additional risk factors for arrythmias (e.g., heart failure, family history of Long QT Syndrome). Known H/O respiratory disorders e.g. asthma, chronic obstructive pulmonary disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Saira Burney, FRCP (Edin)
    Phone
    923014226617
    Email
    dr_syra@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Khadija I Khawaja, FCPS
    Phone
    923009495896
    Email
    khadijairfan@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Saira Burney, FRCP (Edin)
    Organizational Affiliation
    SIMS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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