Post Exposure Prophylaxis in Healthcare Workers Exposed to COVID-19 Patients

NCT04437693 | Unknown Phase 2 DMC

• 1 other identifier: MRC-02-20-442
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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, 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. 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.

Conditions

COVID 19

Keywords

Hydroxychloroquine; Coronavirus Disease 2019; Post Exposure Prophylaxis; Center for Disease Control and Prevention; Coded Record Form

Outcome Measures

Primary Outcomes (3)

• Prevention of SARS-CoV-2 infection

  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

  7 Months

• Presence of any adverse effects related to HCQ

  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

  7 months

• Incidence of COVID-19 related symptoms

  Incidence of COVID-19 related symptoms, that may include: Temperature over 37.8 degrees Celsius, Shortness of Breath, Cough.

  7 weeks

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks.

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

2 tablets (Placebo White tablets) twice daily on day 1 followed by 2 tablets weekly for 7 weeks

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

The treatment group that will receive Hydroxychloroquine (HCQ) 400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks

Also known as: Placebo

Hydroxychloroquine; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nasser Al Ansari, FRCPath

  Hamad Medical Corporation (HMC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasser Al Ansari, FRCPath

CONTACT

33554409; nalansari2@hamad.qa

Rajvir Singh, Ph.D.

CONTACT

55897044; rsingh@hamad.qa

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An interventional, double-blind, placebo-controlled randomized trial

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 18, 2020
• Study Start: August 31, 2020
• Primary Completion: August 30, 2021
• Study Completion: December 31, 2021
• Last Updated: August 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One year
• Access Criteria: 2021 to 2025