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Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care 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: NCT04438837
Recruitment Status : Not yet recruiting
First Posted : June 19, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Nesrin Ghanem-Zoubi MD, Rambam Health Care Campus

Brief Summary:

Background: The rapid spread and high infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) makes identifying an effective prophylaxis agent highly important. One of the important target populations for such intervention who are at high risk of exposure are health care workers (HCWs) who may develop disease and/or expose patients and other HCWs. Hydroxychloroquine (HCQ), currently in usage for treatment of severe Coronavirus Disease 2019 (COVID-19), has in addition to in-vitro activities of inhibition of virus replication and immunomodulation, an important role in the inhibition of pre-entry step of the virus to host cells. Such activity in the early stage of infection may play a role in prevention of disease progression.

Objectives: To evaluate the effect of HCQ in prevention of clinical disease and reduction of viral shedding among HCWs following exposure to confirmed COVID-19 patients.

Study design: Multi-center, randomized controlled, superiority, open label trial Setting: The study will be conducted at Rambam Health Care Campus. Eligibility: Participants eligible for inclusion will include non-pregnant adult (>18 years old) HCWs who were exposed to a confirmed case of COVID-19 without full adherence to droplet precautions. Participants will be eligible in a period no longer than 72 hours after exposure.

Intervention: HCQ will be given in the intervention group in a dosage regimen of 400mg BID in the first day followed by 200mg BID for overall 10 days. Participants in the control group will receive no treatment. Treatment will be started no longer than 72 hours following exposure.

Outcomes: The primary outcome will be the number of participants who develop clinical signs compatible with COVID 19 (defined in full protocol) within 14 days of exposure. Secondary outcomes will include virologically-confirmed COVID 19, disease severity (need for hospitalization, mechanical ventilation and 30-day mortality) and viral shedding duration (time between first positive PCR to last of two consecutive negative tests) for confirmed COVID 19 cases.

Sample size: The trial will test for HCQ's superiority assuming a primary outcome incidence of 20% in the control group and a reduction of 50% with HCQ. The sample size required for a power of 80% (alpha 0.05) is 291 participants per each group.


Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 (COVID-19) Post-Exposure Prophylaxis Drug: Hydroxychloroquine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 582 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers: A Randomized-Controlled Trial
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
No Intervention: control group
no intervention
Active Comparator: intervention group
participants will recieve hydroxychloroquine in a dosage regimen of 400mg BID in the first day followed by 200mg BID for overall 10 days.
Drug: Hydroxychloroquine
Hydroxychloroquine post exposure prohylaxis
Other Name: Plaquenil




Primary Outcome Measures :
  1. Clinical COVID-19 [ Time Frame: 14 days following exposure. ]
    Number of patients developing clinical symptoms and signs compatible with COVID-19 following exposure


Secondary Outcome Measures :
  1. Confirmed COVID-19 [ Time Frame: 14 days following exposure. ]
    PCR- proven COVID-19 (confirmed cases)

  2. Time to virological recovery [ Time Frame: 30 days ]
    Time to virological recovery for participants who develop confirmed COVID-19

  3. Time to symptoms onset [ Time Frame: 14 days ]
    Time to symptoms onset defined as days until start of fever, cough or shortness of breath.

  4. Development of pneumonia [ Time Frame: 14 days ]
    Development of pneumonia- clinical and radiological (chest X ray or CT).

  5. Development of severe disease [ Time Frame: 14 days ]
    Development of severe disease- respiratory failure, mechanical ventilation, severe sepsis, multi-organ failure or acute myocarditis)

  6. Need for hospitalization or ICU [ Time Frame: 14 days ]
    Need for hospitalization, need for ICU admission

  7. Adverse events [ Time Frame: 14 days ]
    Number of adverse events - prolonged QT, arrhythmias, nausea, vomiting

  8. Mortality [ Time Frame: 30 days ]
    All-cause mortality at the end of follow up

  9. Time to de-isolation [ Time Frame: 30 days ]
    Number of days between exposure to de-isolation



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:

  • Adult participant (>18 years)
  • HCW who had a contact without adequate personal protective equipment (PPE) with a confirmed COVID-19 patient.
  • Time between exposure to randomization no longer than 72 hours.
  • Informed consent from participant

Exclusion Criteria:

  • Symptoms compatible with COVID-19 upon randomization
  • Known allergy to HCQ or chloroquine
  • History of any arrhythmia.
  • Severely reduced LV function (Ejection fraction<30%)
  • Retinopathy
  • Pregnancy or breast feeding
  • Concomitant treatment with azithromycin, flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, pimozide.
  • Chronic chloroquine/ HCQ treatment

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): NCT04438837


Contacts
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Contact: Nesrin Ghanem-Zoubi, MD 97247772991 n_ghanem@rambam.health.gov.il

Locations
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Israel
Rambam Health Care Campus
Haifa, Israel
Contact: Nesrin Ghanem-Zoubi       n_ghanem@rambam.health.gov.il   
Principal Investigator: Nesrin Ghanem-Zoubi         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Study Chair: Mical Paul, MD Rambam
Additional Information:
Publications of Results:

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Responsible Party: Nesrin Ghanem-Zoubi MD, Infectious Diseases Institute senior physician, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT04438837    
Other Study ID Numbers: 0193-20-RMB CTIL
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 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 Nesrin Ghanem-Zoubi MD, Rambam Health Care Campus:
COVID-19
severe acute respiratory syndrome coronavirus 2
Hydroxychloroquine
Post-Exposure Prophylaxis
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents