Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT04370015
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Saira Burney, Services Institute of Medical Sciences, Pakistan

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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Healthcare Workers Drug: Hydroxychloroquine Drug: Placebo oral tablet Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blinding
Primary Purpose: Prevention
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
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
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.
Drug: Hydroxychloroquine
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.
Other Name: HCQ

Placebo Comparator: Control group
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.
Drug: Placebo oral tablet
• 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 Measures :
  1. Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period [ Time Frame: From date of randomization until study completion 12 weeks after treatment initiation ]
    Negative RT-PCR for SARS-CoV-2 both at baseline and at end of 12 weeks in experimental arm

  2. Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment [ Time Frame: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation ]
    To assess the presence or absence of side effects from HCQ treatment.


Secondary Outcome Measures :
  1. Confirmed SARS-CoV-2 infection based on symptoms and confirmed by RT-PCR [ Time Frame: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation ]
    Symptomatic infection by SARS-CoV-2 defined as cough, dyspnea, fever, myalgia, arthralgia or rhinorrhea.

  2. Clinical disease severity in confirmed SARS-CoV-2 participants [ Time Frame: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation ]
    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.

  3. Incidence of any acute respiratory infection [ Time Frame: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370015


Contacts
Layout table for location contacts
Contact: Saira Burney, FRCP (Edin) 923014226617 dr_syra@hotmail.com
Contact: Khadija I Khawaja, FCPS 923009495896 khadijairfan@gmail.com

Sponsors and Collaborators
Services Institute of Medical Sciences, Pakistan
Investigators
Layout table for investigator information
Principal Investigator: Saira Burney, FRCP (Edin) SIMS
Layout table for additonal information
Responsible Party: Dr. Saira Burney, Doctor, Services Institute of Medical Sciences, Pakistan
ClinicalTrials.gov Identifier: NCT04370015    
Other Study ID Numbers: 16082019
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Dr. Saira Burney, Services Institute of Medical Sciences, Pakistan:
SARS-CoV-2
HCQ
prophylaxis
healthcare workers
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents