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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04446104
Recruitment Status : Completed
First Posted : June 24, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

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.


Condition or disease Intervention/treatment Phase
Covid-19 Drug: Hydroxychloroquine Sulfate Tablets Drug: Ivermectin 3mg Tab Drug: Zinc Drug: Povidone-Iodine Dietary Supplement: Vitamin C Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Open-label Prophylaxis Trial Among Migrant Workers at High-risk of COVID-19 (DORM Trial)
Actual Study Start Date : May 13, 2020
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: Hydroxychloroquine
Participants will receive hydroxychloroquine tablet 400mg loading dose, followed by 200mg daily for 42 days
Drug: Hydroxychloroquine Sulfate Tablets
Hydroxychloroquine tablet 400mg loading dose, followed by 200mg daily for 42 days

Experimental: Ivermectin
Participants will receive ivermectin tablet 12mg single dose
Drug: Ivermectin 3mg Tab
Ivermectin tablet 12mg single dose

Experimental: Zinc/ Vitamin C
Participants will receive zinc tablet 80 mg/vitamin C 500mg daily for 42 days
Drug: Zinc
Zinc tablet 80 mg/vitamin C 500mg daily for 42 days

Experimental: Povidone-iodine throat spray
Participants will receive povidone-iodine throat spray (3 times daily) for 42 days
Drug: Povidone-Iodine
Povidone-iodine throat spray (3 times daily) for 42 days

Active Comparator: Vitamin C
Participants will receive vitamin C tablet 500mg daily for 42 days
Dietary Supplement: Vitamin C
Vitamin C tablet 500mg daily for 42 days




Primary Outcome Measures :
  1. Laboratory-confirmed COVID-19 in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine) [ Time Frame: At the end of study dosing, which is day 42 ]

Secondary Outcome Measures :
  1. Acute respiratory illness in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine) [ Time Frame: At the end of study dosing, which is day 42 ]
    Acute respiratory illness is defined by acute onset with any key respiratory symptoms including cough, shortness of breath, sore throat, runny nose and change in smell.

  2. Febrile respiratory illness in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine) [ Time Frame: At the end of study dosing, which is day 42 ]
  3. Rate of hospitalization for COVID-19 and non-COVID-19 related indications in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine) [ Time Frame: At the end of study dosing, which is day 42 ]
  4. Rate of oxygen supplementation and mechanical ventilation in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine) [ Time Frame: At the end of study dosing, which is day 42 ]
  5. Duration of oxygen supplementation and mechanical ventilation in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine) [ Time Frame: At the end of study dosing, which is day 42 ]
  6. Length of hospital stay in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine) [ Time Frame: At the end of study dosing, which is day 42 ]
  7. Rate of laboratory-confirmed COVID-19 in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine) [ Time Frame: At the end of study dosing, which is day 42 ]
  8. Adverse events and serious adverse events in control arm (Vitamin C) [ Time Frame: At the end of study dosing, which is day 42 ]
  9. Drug discontinuation due to adverse events in control arm (Vitamin C) [ Time Frame: At the end of study dosing, which is day 42 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).
  • Unwilling to comply with study dosing, instructions or restrictions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04446104


Locations
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Singapore
Tuas South Dormitory
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT04446104    
Other Study ID Numbers: 2020/00561
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ascorbic Acid
Hydroxychloroquine
Ivermectin
Povidone-Iodine
Povidone
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Antioxidants
Protective Agents
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local