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COVID-19 Prophylaxis With Hydroxychloroquine Associated With Zinc For 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: NCT04384458
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
betemora, Universidade Federal do Ceara

Brief Summary:
We have to be aware of the challenge and concerns brought by 2019-nCoV to our healthcare workers. Front-line healthcare workers can become infected in the management of patients with COVID-19; the high viral load in the atmosphere, and infected medical equipment are sources for the spread of SARS-CoV-2. If prevention and control measures are not in place, these healthcare workers are at great risk of infection and become the inadvertent carriers to patients who are in hospital for other diseases. Nowadays a question that has not yet been clarified by science has been arises: is hydroxychloroquine associated with zinc effective as a prophylaxis for asymptomatic healthcare workers involved in the treatment of suspected or confirmed cases of COVID-19?

Condition or disease Intervention/treatment Phase
Coronavirus Infections Drug: Hydroxychloroquine Not Applicable

Detailed Description:

The study is a open-blind, non-randomised trial that will be conducted in healthcare settings. After obtaining fully informed consent, the investigator will recruit healthcare workers in a healthcare facility delivering direct care to patients with either proven or suspected COVID-19.

Participants will be divided into 2 groups - intervention (HCQ = 400mg twice on day 1, 400mg / day on day 2, 3, 4, and 5 followed by 400mg once every 05 days, for the next 7 weeks associated with 66 milligrams of zinc sulfate daily for 50 consecutive days; and control group (healthcare workers who decided not to receive the study medication, but who agreed to participate as a control group).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a open-blind, non-randomised trial that will be conducted in healthcare settings
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: COVID-19 Prophylaxis With Hydroxychloroquine Associated With Zinc For High-Risk Healthcare Workers Involved In Suspected, or Confirmed Cases of COVID-19.
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Active Comparator: Hydroxychloroquine
Oral hydroxychloroquine 400 mg twice a day on day 1, one 400 mg tablet on day 2, 3, 4, and 5, followed by one 400 mg tablets every 05 days until day 50th associated with 66 mg of zinc sulfate.
Drug: Hydroxychloroquine
Oral hydroxychloroquine 400 mg twice a day on day 1, one 400 mg tablet on day 2, 3, 4, and 5, followed by one 400 mg tablets every 05 days until day 50th associated with 66 mg of zinc sulfate.

No Intervention: Control
Subjects who don't want not to receive the study drug, but agree to participate by signing the informed consent, will form the control group



Primary Outcome Measures :
  1. Proportion of participants in whom there was a clinical finding of COVID-19. [ Time Frame: Day 50 ]
    Proportion of participants in whom there was a clinical finding of COVID-19, defined as the occurrence of signs and symptoms suggestive of this disease, corroborated by the detection of SARS-CoV-2 through specific examination (RT-PCR) or by serology for antibodies specific (IgM and IgG).

  2. Symptomatic COVID-19 infections. [ Time Frame: Day 50 ]
    Number of symptomatic COVID-19 infections.


Secondary Outcome Measures :
  1. Healthcare Workers who developed mild, moderate, or severe forms of COVID-19. [ Time Frame: Day 50 ]
    Proportion of Healthcare Workers who developed mild, moderate, or severe forms of COVID-19.

  2. Measurement of the QT interval. [ Time Frame: Day 0, day 15 and day 50 ]
    Measurement of the QT interval through electrocardiogram evaluation.

  3. Widening of the corrected QT interval or with changes in heart rate on the ECG. [ Time Frame: Day 15 and day 50. ]
    Proportion of Healthcare Workers who evolved with widening of the corrected QT interval or with changes in heart rate on the ECG.

  4. Comparison of hematological and biochemical parameters. [ Time Frame: Day 50 ]
    Comparison of baseline (visit 1) and final (visit 4) values of hematological and biochemical parameters.

  5. Occurrence of adverse events. [ Time Frame: Day 50 ]
    Proportion of occurrence of adverse events reported by Healthcare Workers or verified by the attending physician, or even observed in laboratory tests.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 - 70 years;
  • Healthcare workers in a healthcare facility delivering direct care to patients with either proven or suspected COVID-19;
  • Understands and agrees to comply with planned study procedures;
  • Signed informed consent for participation in the study.

Exclusion Criteria:

  • Pregnancy or breastfeeding;
  • Major allergy to Hidroxychloroquine, chloroquine or 4-aminoquinolines;
  • Serum potassium lower than 3.4 mEq/l;
  • Serum calcium lower than 4.65 mg/dL;
  • Serum magnesium lower than 1.7 mg/dL;
  • Known history of long QT syndrome;
  • QTc interval > 450 ms;
  • Weight < 40 kg;
  • Severe liver disease;
  • Severe kidney disease;
  • Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone;
  • Known retinal 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): NCT04384458


Contacts
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Contact: Elisabete A Moraes, Professor +5585991219290 betemora@ufc.br

Locations
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Brazil
Drug Research and Development Center (NPDM), Federal University of Ceará (UFC)
Fortaleza, Ceará, Brazil, 60430-275
Contact: Elisabete A Moraes, Professor    +5585991219290    betemora@ufc.br   
Contact: A         
Sponsors and Collaborators
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
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Responsible Party: betemora, MD, PhD, Universidade Federal do Ceara
ClinicalTrials.gov Identifier: NCT04384458    
Other Study ID Numbers: HCQZn
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by betemora, Universidade Federal do Ceara:
Coronavirus Infections
Health Personnel
Hydroxychloroquine
Pre-Exposure Prophylaxis
Antimalarials
Antirheumatic Agents
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents