A Preventive Treatment for Migrant Workers at High-risk of COVID-19

NCT04446104 | Completed Phase 3

• 1 other identifier: 2020/00561
• Study Type: interventional
• Target: 4,257
• Locations: 1 country
• Sites: 1

Brief Summary

In December 2019, a novel coronavirus, now called COVID-19, emerged as a global health threat from Wuhan, China. Within weeks, the contagious virus spread within and between communities, causing a lower respiratory tract infection dominated by symptoms of fever, cough and sore throat. The incubation period was estimated at between 5 to 7 days, but could last as long as 14 days. Although COVID-19 causes a mostly mild and self-limiting disease, respiratory involvement has been reported in about 5% of the population, requiring supplemental oxygen and even ventilatory support to relieve hypoxia. Alveolar damage, fibrosis and consolidation have been reported in radiologic and post-mortem studies. Existing data suggest a mortality rate of COVID-19 is approximately 1-2%, higher among individuals with pre-existing comorbidities and in healthcare systems with suboptimal access to ventilatory support. Given its high transmissibility, COVID-19 has quickly spread across the globe within a short interval. By 27 April 2020, over 3 million people around the world have been diagnosed with COVID-19, and more 200,000 have succumbed to the disease. As a proportion of patients manifest mild or no symptoms, these numbers are likely an underestimate of the actual number of patients with COVID-19. More disconcertingly, patients are known to shed viruses despite mild or no symptoms, making it essential that a collective approach against COVID-19 incorporate active pharmacological treatment to prevent or mitigate virus pathogenesis prior to its potential evolution to cause respiratory distress. To date, clinical trials have focused on the treatment of hospitalised patients diagnosed with COVID-19; only few have examined the clinical benefits of pharmacological agents despite few compelling in vitro data. The relatively high transmission of COVID-19 in a closed dormitory environment of migrant workers in Singapore presents a real-life scenario where a prophylaxis treatment could reduce the impact of the disease. In Singapore, there are well grounded concerns an excess in cases could pose the possibility of strain in healthcare system and mentally drain her workers. The availability of an effective prophylaxis treatment is highly desirable to potentially reduce this burden. Data from the current study could also have implications on how future outbreaks in high-density areas should be managed, especially when residents are subjected to quarantine and isolation.

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

• Laboratory-confirmed COVID-19 in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)

  At the end of study dosing, which is day 42

Secondary Outcomes (9)

• Acute respiratory illness in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)

  At the end of study dosing, which is day 42

• Febrile respiratory illness in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)

  At the end of study dosing, which is day 42

• Rate of hospitalization for COVID-19 and non-COVID-19 related indications in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)

  At the end of study dosing, which is day 42

• Rate of oxygen supplementation and mechanical ventilation in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)

  At the end of study dosing, which is day 42

• Duration of oxygen supplementation and mechanical ventilation in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)

  At the end of study dosing, which is day 42

Study Arms (5)

Hydroxychloroquine

EXPERIMENTAL

Participants will receive hydroxychloroquine tablet 400mg loading dose, followed by 200mg daily for 42 days

Drug: Hydroxychloroquine Sulfate Tablets

Ivermectin

EXPERIMENTAL

Participants will receive ivermectin tablet 12mg single dose

Drug: Ivermectin 3mg Tab

Zinc/ Vitamin C

EXPERIMENTAL

Participants will receive zinc tablet 80 mg/vitamin C 500mg daily for 42 days

Drug: Zinc

Povidone-iodine throat spray

EXPERIMENTAL

Participants will receive povidone-iodine throat spray (3 times daily) for 42 days

Drug: Povidone-Iodine

Vitamin C

ACTIVE COMPARATOR

Participants will receive vitamin C tablet 500mg daily for 42 days

Dietary Supplement: Vitamin C

Interventions

Hydroxychloroquine Sulfate Tablets DRUG

Hydroxychloroquine tablet 400mg loading dose, followed by 200mg daily for 42 days

Hydroxychloroquine

Ivermectin 3mg Tab DRUG

Ivermectin tablet 12mg single dose

Ivermectin

Zinc DRUG

Zinc tablet 80 mg/vitamin C 500mg daily for 42 days

Zinc/ Vitamin C

Povidone-Iodine DRUG

Povidone-iodine throat spray (3 times daily) for 42 days

Povidone-iodine throat spray

Vitamin C DIETARY_SUPPLEMENT

Vitamin C tablet 500mg daily for 42 days

Vitamin C

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet all the of following criteria to be included in this study:
• Men residing in dormitory aged 21-60 years
• Willing and able to give informed consent
• Able to understand instructions and consume study medications according to the study protocol.
• Weight more than 40kg
• Owns a mobile phone (with wireless fidelity and/or 3G connection and able to fill in online forms.

You may not qualify if:

• Subjects who have any of the following criteria at baseline will be excluded from participating in this study:
• Symptoms of acute respiratory illness (e.g. fever, runny nose, sore throat, cough, breathlessness, loss of smell and loss of taste) for the past 30 days
• Known current or history of SARS-CoV-2 infection
• Unable to read English or any of the available local languages used for this clinical trial
• History of cardiac or neurological diseases
• History of retinal diseases
• History of diabetes on insulin treatment
• History of depression
• History of chronic alcohol use
• History of renal or hepatic dysfunction
• History of glucose-6-phosphate dehydrogenase deficiency
• History of anaemia, after exposure to any given medications
• History of thyroid disorder, hyperthyroidism, or sensitivity to iodine
• History of allergies with systemic presentation to any given medication (e.g.: swelling of the face, throat, eyes and lips, respiratory disturbances, asthmatic attacks, widespread skin blistering or urticaria (hives))
• Concomitant medication that may lead to cardiac arrhythmia (azithromycin, amitriptyline, cimetidine, citalopram, nortriptyline, pantoprazole, quetiapine etc).

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

Tuas South Dormitory

Singapore, Singapore

Location

Related Publications (1)

• Teng O, Quek AML, Ooi DSQ, Wang S, Fragata L, Ng IXQ, Cui J, Chen J, Hartman M, Hutchinson PE, Tambyah PA, Seet RCS. High CD4(+) T-cell responses in seronegative individuals following SARS-CoV-2 exposure during a dormitory outbreak. Int J Infect Dis. 2025 Oct;159:108024. doi: 10.1016/j.ijid.2025.108024. Epub 2025 Aug 20.

  PMID: 40845939 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Ivermectin; Zinc; Povidone-Iodine; Ascorbic Acid

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; Macrolides; Polyketides; Lactones; Organic Chemicals; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Iodophors; Iodine Compounds; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: June 24, 2020
• Study Start: May 13, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)