Hydroxychloroquine in prevention of sever forms of COVID-19 in healthcare workers

A Field Trial to examine the effect of hydroxychloroquine prophylaxis in preventing the sever forms of COVID-19 infection in asymptomatic healthcare workers (A double blind placebo controlled study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200424047184N1

Enrollment

400

Registered

2021-01-16

Start date

2020-04-03

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. COVID19, virus identified

Interventions

Intervention 1: Intervention group:The intervention group will take 800 mg i.e four 200 mg tablets of hydroxychloroquine in two separate doses once

and then 400 mg weekly in a single dose for 7 weeks and will be followed-up for 10 weeks. Drug and placebo are made by Tehran Darou Pharmaceutical Company. Intervention 2: Control group: Control grou

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Healthcare workers and students of Islamic Azad University Tehran Medical Branch(IAUTMU) affiliated hospitals. Age 18-70 years No symptoms of COVID19 at the time of registration No history of COVID-19 diagnosis within the past 3 months from joining the study Desire to participate in the study and filling out the consent form

Exclusion criteria

Exclusion criteria: Any of COVID-19 symptoms at registration: fever, chills, cough, dyspnea,runny nose, loss of smell, loss of taste, headache, sore throat, chest pain, abdominal pain, nausea, vomiting, diarrhea, malaise and musculoskeletal pain History of COVID-19 within the past 3 months Contraindications for hydroxychloroquine including allergy to hydroxychloroquine , G6PD, Long QT Syndrome, porphyria, retinopathy Pregnancy Sever kidney or liver disease HIV, AIDS Systemic lupus erythematosus, rheumatoid arthritis active cancer

Design outcomes

Primary

Measure	Time frame
Sever forms of COVID-19( sever dyspnea, chest pain, decreased level of consciousness based on CDC definition) needing admission to hospital. Timepoint: Weekly for 10 weeks or until the discharge from hospital whichever is longer. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms.;Sever forms of COVID-19 Diseases needing admission to ICU due to respiratory failure. Timepoint: Weekly for 10 weeks or until the discharge from hospital whichever is longer. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms.;Mortality. Timepoint: weekly for 10 weeks or until discharge from hospital whichever is longer. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms.;Mild types of COVID-19 with at least one of the symptoms of fever, cough, dyspnea, myalgia, loss of smell or taste, flu like symptoms with either polymerase-chain-reaction (PCR) confirmed COVID-19 or Positive CT scan suggestive of COVID-19. Timepoint: Weekly for 10 weeks. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms.	—

Measure

Time frame

Sever forms of COVID-19( sever dyspnea, chest pain, decreased level of consciousness based on CDC definition) needing admission to hospital. Timepoint: Weekly for 10 weeks or until the discharge from hospital whichever is longer. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms.;Sever forms of COVID-19 Diseases needing admission to ICU due to respiratory failure. Timepoint: Weekly for 10 weeks or until the discharge from hospital whichever is longer. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms.;Mortality. Timepoint: weekly for 10 weeks or until discharge from hospital whichever is longer. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms.;Mild types of COVID-19 with at least one of the symptoms of fever, cough, dyspnea, myalgia, loss of smell or taste, flu like symptoms with either polymerase-chain-reaction (PCR) confirmed COVID-19 or Positive CT scan suggestive of COVID-19. Timepoint: Weekly for 10 weeks. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms.

—

Secondary

Measure	Time frame
Drug side effect. Timepoint: weekly for 7 weeks. Method of measurement: Weekly phone calls and filling out the questionnaire forms.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahnaz Valizadeh

Islamic Azad University

valizadeh@iautmu.ac.ir+98 21 2285 9098

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026