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

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Hydroxychloroquine

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