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Post Exposure Prophylaxis in Healthcare Workers Exposed to COVID-19 Patients (HCQ-COVID19)

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: NCT04437693
Recruitment Status : Not yet recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation

Brief Summary:

More cases of COVID-19 pandemic are being reported daily around the world. It is highly infectious and, over 7 million people have been infected and more than 400,000 people have died globally till this date. Countries around the world are struggling to avoid the spread of this pandemic.

Center for Disease Control and Prevention (CDC) confirmed that there are no approved drugs for COVID-19 treatment. Researchers around the globe, however, are researching different medications for COVID-19 patients, including the drug Hydroxychloroquine (HCQ), which is mainly used for Rheumatoid Arthritis and Malaria. Not enough data was obtained yet to know how well all of these medications are functioning. Therefore, we aim to perform a randomized placebo-controlled trial to assess the impact of these medications on COVID -19 healthcare workers exposed while treating COVID 19 patients in Qatar to avoid causality and comorbidities in healthcare workers.

It is considered as a weak base. Many viruses enter the host cells via endocytosis, as a result of which they are initially taken up into an intracellular compartment that is "typically fairly acidic" whereas; Hydroxychloroquine would alter the acidity of this compartment, which can interfere with the ability of viruses to escape into the host cell and start replicating. Another hypothesis on the rationale of the Antiviral activity of HCQ, is that HCQ may also alter the ability of the virus to bind to the outside of a host cell in the first place.

An interventional, double-blind, placebo-controlled randomized trial that will include participants who will be healthcare workers at risks of exposure to COVID-19 while managing patients with confirmed infection.

Our study will compare the safety, efficacy and effectiveness of Post Exposure Prophylaxis (PEP) use of HCQ in healthcare workers at risk of exposure to COVID-19 patients, in comparison to Placebo in Qatar.


Condition or disease Intervention/treatment Phase
COVID 19 Drug: Hydroxychloroquine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An interventional, double-blind, placebo-controlled randomized trial
Masking: Double (Participant, Investigator)
Masking Description: The process of keeping the study group assignment hidden after allocation will be used where the investigator and participants will be unaware of the drug.A double blind randomized clinical trial has been proposed having 250 subjects in each arm. 500 subjects will be selected using randomly permuted blocks of 2,4, and 8 for the random process to allocate subjects into the two groups equally by using computer software.
Primary Purpose: Prevention
Official Title: Post Exposure Prophylaxis (PEP) in Healthcare Workers Exposed to COVID-19 Patients: A Double-blind Randomized Clinical Trial
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine
400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks.
Drug: Hydroxychloroquine
The treatment group that will receive Hydroxychloroquine (HCQ) 400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks
Other Name: Placebo

Placebo Comparator: Placebo
2 tablets (Placebo White tablets) twice daily on day 1 followed by 2 tablets weekly for 7 weeks
Drug: Hydroxychloroquine
The treatment group that will receive Hydroxychloroquine (HCQ) 400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks
Other Name: Placebo




Primary Outcome Measures :
  1. Prevention of SARS-CoV-2 infection [ Time Frame: 7 Months ]
    Prevention of SARS-CoV-2 infection as determined by negative RT-PCR of the participants in the treatment group through swabbing that will be conducted on a weekly basis (Swabbing will be conducted at baseline and weekly through the end of the treatment period

  2. Presence of any adverse effects related to HCQ [ Time Frame: 7 months ]
    To find out the adverse effects related to HCQ such as : skin rashes, especially those made worse by sunlight, feeling sick (nausea) or indigestion, diarrhea, headaches, bleaching of the hair or mild hair loss, tinnitus (ringing in the ears) visual problem

  3. Incidence of COVID-19 related symptoms [ Time Frame: 7 weeks ]
    Incidence of COVID-19 related symptoms, that may include: Temperature over 37.8 degrees Celsius, Shortness of Breath, Cough.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or older, all healthcare workers in direct contact with COVID-19 patients (ex: physicians, nurses, pharmacists, etc.), the ability to swallow Oral medications, without any GI abnormalities that may affect absorption. Who agree to participate in the trial.

Exclusion Criteria:

  • Allergy to HCQ.
  • Pregnancy or breastfeeding.
  • Known history of Retinal disease not related to Macular degeneration, or preexisting eye retinopathy.
  • Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia.
  • Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
  • Having dermatitis, psoriasis, or porphyria.
  • History of lung disease or Pneumonia not related to COVID-19.
  • Taking CYP450 enzyme-inducing medications within 4 weeks of the start of taking HCQ (Ex: Phenytoin, Carbamazepine, Phenobarbital, Primidone or Oxcarbazepine.
  • Currently taking QT-prolonging medications, which may include Antiarrhythmics, Quinolones, Macrolides, select Antipsychotics and Antidepressants.
  • Team members planning to have major abdominal, thoracic, spine or CNS surgery during the protocol period

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): NCT04437693


Contacts
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Contact: Nasser Al Ansari, FRCPath 33554409 nalansari2@hamad.qa
Contact: Rajvir Singh, Ph.D. 55897044 rsingh@hamad.qa

Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Principal Investigator: Nasser Al Ansari, FRCPath Hamad Medical Corporation (HMC)
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
https://www.worldometers.info/coronavirus/
Clinical Study Report  This link exits the ClinicalTrials.gov site
https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf
Clinical Study Report  This link exits the ClinicalTrials.gov site
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/groups-at-higher-risk.html

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Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT04437693    
Other Study ID Numbers: MRC-02-20-442
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a plan to make IPD and related data dictionaries available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: One year
Access Criteria: 2021 to 2025

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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 Hamad Medical Corporation:
Hydroxychloroquine
Coronavirus Disease 2019
Post Exposure Prophylaxis
Center for Disease Control and Prevention
Coded Record Form
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents