Hydroxychloroquine Chemoprophylaxis for COVID-19 Infection in High-risk Healthcare Workers.

NCT04370015 | Unknown

• 1 other identifier: 16082019
• Study Type: interventional
• Target: 374
• Locations: 0 countries
• Sites: N/A

Brief Summary

Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. There are in vitro studies available which show inhibition of corona virus by hydroxychloroquine, a widely-used agent against malaria and certain autoimmune conditions and of low-cost and limited toxicity. However, evidence regarding its effects in patients is limited. We plan to conduct a randomized controlled trial to evaluate the safety and potential prophylactic efficacy of hydroxychloroquine in preventing secondary SARS-CoV-2 infection among healthcare workers at high-risk of exposure while managing such patients.

Conditions

SARS-CoV-2; Healthcare Workers

Keywords

SARS-CoV-2; HCQ; prophylaxis; healthcare workers

Outcome Measures

Primary Outcomes (2)

• Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period

  Negative RT-PCR for SARS-CoV-2 both at baseline and at end of 12 weeks in experimental arm

  From date of randomization until study completion 12 weeks after treatment initiation

• Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment

  To assess the presence or absence of side effects from HCQ treatment.

  From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

Secondary Outcomes (3)

• Confirmed SARS-CoV-2 infection based on symptoms and confirmed by RT-PCR

  From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

• Clinical disease severity in confirmed SARS-CoV-2 participants

  From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

• Incidence of any acute respiratory infection

  From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

Study Arms (2)

Treatment group

EXPERIMENTAL

Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with oral hydroxychloroquine 400 mg twice a day (four 200 mg tablets) on day 1 followed by 400mg (two 200 mg tablets) once a week for 11 weeks.

Drug: Hydroxychloroquine

Control group

PLACEBO COMPARATOR

Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with placebo twice a day (four tablets) on day 1 followed by 2 tablets once a week for 11weeks.

Drug: Placebo oral tablet

Interventions

Hydroxychloroquine DRUG

Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with oral hydroxychloroquine 400 mg twice a day (four 200 mg tablets) on day 1 followed by 400mg (two 200 mg tablets) once a week for 11 weeks.

Also known as: HCQ

Treatment group

Placebo oral tablet DRUG

• Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with placebo twice a day (four tablets) on day 1 followed by 2 tablets once a week for 11weeks.

Control group

Eligibility Criteria

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

You may qualify if:

• Adult healthcare workers all genders ≥ 18 to ≤ 60 years of age upon study consent.
• Healthcare workers (doctors and nurses) at Services hospital, Lahore considered work at high-risk of SARS-CoV-2 exposure (defined below):
• Healthcare workers in Corona triage areas.
• Healthcare workers in Corona Isolation Units.
• Healthcare workers in Corona ICUs.
• Healthcare workers in general medical wards.
• Healthcare workers in general surgical wards.
• Healthcare workers in other units not directly dealing with suspected Corona patients e.g. Endocrinology department
• Afebrile with no constitutional symptoms.
• No household contact with confirmed active SARS-CoV-2 infection in the last 3 weeks.
• Negative PCR at visit 0.
• Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
• Willing to not take any other medicines especially fluoroquinolones and macrolides for the duration of study.
• Signed informed consent, demonstrating that the subject understands the interventions required for the study and the purpose of the study.

You may not qualify if:

• Participation in other investigational clinical trials for the treatment or prevention of SARS-CoV-2 infection within 30days.
• Subjects unwilling to practice at least one highly effective method of birth control for the duration of the study.
• Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia or prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
• Having H/O skin disorders e.g. dermatitis, psoriasis or porphyria.
• Taking any of the following medication:
• Anti-arrythmic agents including digoxin.
• GI drugs including antacids, proton-pump inhibitors, cimetidine.
• Anti-cancer treatment including methotrexate, cyclosporin.
• Anti-diabetic agents including insulin.
• Corticosteroids.
• Drugs causing QT interval prolongation especially antidepressants, anti-epileptics and macrolides.
• Drugs affecting electrolyte balance including diuretics, laxatives.
• Drug allergies: 4-Aminoquinolines.
• Pre-existing retinopathy/maculopathy of the eye.
• Known chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis.

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

MeSH Terms

Interventions

Hydroxychloroquine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Saira Burney, FRCP (Edin)

  SIMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saira Burney, FRCP (Edin)

CONTACT

923014226617; dr_syra@hotmail.com

Khadija I Khawaja, FCPS

CONTACT

923009495896; khadijairfan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinding
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: parallel assignment

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: May 15, 2020
• Primary Completion: June 30, 2020
• Study Completion: October 15, 2020
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share