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Hydroxychloroquine to Prevent SARS-CoV-2 Infection

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: NCT04414241
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

Brief Summary:
The purpose of this study is to determine whether hydroxychloroquine is an effective prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants will be randomized into two parallel groups. The first arm will evaluate the use of hydroxychloroquine every-other-day plus standard measures of protection for the prevention of SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of COVID-19 symptoms for 8 weeks.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Drug: Hydroxychloroquine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine
Hydroxychloroquine prophylaxis plus standard measures of personal protection.
Drug: Hydroxychloroquine
A loading dose of 600mg of hydroxychloroquine orally on the first day, followed by 400mg of hydroxychloroquine orally every-other-day and use of standard measures of personal protection provided from the hospital for 8 weeks.

No Intervention: Control
Standard measures of personal protection.



Primary Outcome Measures :
  1. Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2 [ Time Frame: Eight weeks ]
  2. Safety: Proportion of participants with grade 3 or more adverse events [ Time Frame: Eight weeks ]

Secondary Outcome Measures :
  1. Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events [ Time Frame: Eight weeks ]


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.


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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:

  1. Healthcare workers in service during the COVID-19 outbreak including medical, nurse, technical, and auxiliary staff.
  2. Negative rapid serologic and molecular testing for SARS-CoV-2.
  3. Written informed consent.

Exclusion Criteria:

  1. Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell, and taste.
  2. Prior (last 30 days), current or planned use (during study period) of hydroxychloroquine, chloroquine sulfate, or azithromycin.
  3. Known cardiac disease or a history of prolonged QT syndrome.
  4. Known allergy or intolerance to hydroxychloroquine and/or chloroquine sulfate.
  5. Use of concomitant medications that are contraindicated with the use of hydroxychloroquine.
  6. Other reported medical conditions, such as glucose-6-phosphate dehydrogenase deficiency, hepatic or renal insufficiency, or visual acuity or field disturbances, that make study participation not in the individual's best interest.

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): NCT04414241


Contacts
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Contact: Alvaro Schwalb, MD (+51)988054875 alvaro.schwalb@upch.pe
Contact: César Ugarte-Gil, MD, MSc, PhD (+51)997157333 cesar.ugarte@upch.pe

Locations
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Peru
Centro Médico Naval "Cirujano Mayor Santiago Távara"
Callao, Peru, 07006
Contact: Rosio Guerra, MD, MPH       rosio.guerra@med.navy.mil   
Principal Investigator: Rosio Guerra, MD, MPH         
Hospital Nacional Hipólito Unanue
Lima, Peru, 15007
Contact: Alonso Soto, MD, MSc, PhD       sotosolari@gmail.com   
Principal Investigator: Alonso Soto, MD, MSc, PhD         
Hospital Nacional Arzobispo Loayza
Lima, Peru, 15082
Contact: Aldo Lucchetti, MD       aldolucchetti@gmail.com   
Principal Investigator: Aldo Lucchetti, MD         
Hospital Cayetano Heredia
Lima, Peru, 15102
Contact: Fernando Mejia, MD, MSc       fernando.mejia.c@upch.pe   
Principal Investigator: Fernando Mejia, MD, MSc         
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Investigators
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Principal Investigator: Alejandro Llanos, MD, PhD Universidad Peruana Cayetano Heredia
Study Chair: Eduardo Gotuzzo, MD Universidad Peruana Cayetano Heredia
Study Chair: Max Grogl, PhD U.S. Naval Medical Research Unit Six
Study Chair: Patricia García, MD, MPH, PhD Universidad Peruana Cayetano Heredia
Study Chair: Manuel Espinoza, MD Instituto de Nacional de Salud
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Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT04414241    
Other Study ID Numbers: 202087
20923 ( Other Identifier: OGITT-INS )
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Universidad Peruana Cayetano Heredia:
SARS-CoV-2 infection
Hydroxychloroquine
Additional relevant MeSH terms:
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Infection
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents