Home » Trials » SLCTR/2020/011
Hydroxychloroquine for Post-Exposure Prophylaxis of COVID-19 among naval personnel: a placebo-controlled, randomized, clinical trial
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SLCTR Registration Number
SLCTR/2020/011
Date of Registration
The date of last modification
Oct 02, 2020
Scientific Title of Trial
Hydroxychloroquine for Post-Exposure Prophylaxis of COVID-19 among naval personnel: a placebo-controlled, randomized, clinical trial
Public Title of Trial
Hydroxychloroquine for Post-Exposure Prophylaxis of COVID-19 among naval personnel: a placebo-controlled, randomized, clinical trial
Disease or Health Condition(s) Studied
Post-exposure prophylaxis for COVID-19
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1251-3613
Any other number(s) assigned to the trial and issuing authority
P/22/04/2020 (ERC: Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
What is the efficacy of hydroxychloroquine when compared to placebo for Post-Exposure Prophylaxis among naval personnel with exposure to COVID-19 positive patients?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Healthcare providers, Outcome assessors
Control
Placebo
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 4
Intervention(s) planned
This will be a placebo-controlled, randomized, clinical trial.
The study will be carried out among all eligible persons meeting the inclusion/exclusion criteria directed to be quarantined in quarantine centers (QCs) of the Sri Lanka Navy, Ministry of Defense
Informed consent will be obtained, and a patient information leaflet will be provided. Those willing to undergo the trial will be randomized and monitored for development of symptoms or rRT-PCR positivity for SARS-CoV-2 virus. All eligible participants who test negative for the virus on rRT-PCR at baseline, will be randomly assigned to the following study arms within 48 hours of admission.
Participants will be allocated to the study arms using simple randomization where each personnel will be considered as a unit. A list of the Navy personnel in the Quarantine centers (QCs) along with their names and national identity card numbers will be obtained. Each personnel will be given a unique number starting from 1 up to the total number of personnel undergoing quarantine in all the QCs. This will be used as a sampling frame for selecting study participants.
Microsoft Excel will be used to generate 400 random numbers without replacement from an integer vector starting from 1 to total number of persons in the QCs and the resulted numbers will be recorded in the exact order which they are generated. The personnel belong to the first 200 random identification numbers in the list will be selected to the intervention group (i.e. receive the envelops numbered from 1 to 200) and the second 200 will be selected to the control group (i.e. receive the envelops numbered from 201 to 400).
Allocation concealment will be maintained by packing the interventional product and the placebo in similar envelopes. The first 200 envelops will contain the interventional product and the second 200 will contain placebo. These envelops will be numbered sequentially from 1 to 400 and will be handed over to the identified QCs. Each personnel will receive the relevant envelop based on the allocated random number.
Arm 1: Intervention arm (n=200)
Participants will receive a loading dose of oral hydroxycholoquine (HCQ) 400mg 12 hourly Day 1 followed by oral HCQ 200mg 12 hourly for the next 4 days.
Arm 2: Control arm (n=200)
Participants will receive a matching placebo (oral tablet containing 100mg of elemental calcium) 2 tablets to be taken orally, 12 hourly on Day 1, followed by 1 tablet orally, 12 hourly for the next 4 days.
Inclusion criteria
All consenting male and female adult Naval personnel (18-59.9 years of age)
Exposure to a patient with confirmed COVID-19 infection (rRT-PCR positive for SARS-CoV-2 virus)
The exposure should be for >30 mins within 2 meters of the infected individual and should be within ONE WEEK at the time of inclusion in the study
Recruited within 48 hours of admission to these centers
Willing to take study drug as directed for 5 days.
Exclusion criteria
Pregnant females
Suspected or confirmed to have COVID-19 infection (i.e Navy personnel having positive rRT-PCR test for COVID-19 or presence of fever with cough, shortness of breath, sore throat, anosmia or diarrhoea at the time of recruitment)
Presence of pre-existing cardiovascular disease including being on medication for ischaemic heart disease
Presence of contraindication to the use of HCQ (on other medications predisposing to long QT or presence of long QT on baseline ECG)
Prior diagnosis of retinopathy, G6PD, malignancy or advanced kidney disease
Known sensitivity or allergy to Hydroxychloroquine
Primary outcome(s)
|
1.
Number of participants symptomatic for COVID-19. (Symptomatic illness will be defined as presence of fever with cough, shortness of breath, sore throat, anosmia or diarrhoea) |
[ Time frame: from the time of recruitment until the completion of 14 days ] |
|
2.
Number of participants testing positive for SARS-CoV-2 virus using rRT-PCR |
[ Time frame: day 14 from the time of recruitment ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
400 (200 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2020-05-04
Anticipated end date
2020-05-31
Date of first enrollment
2020-05-04
Date of study completion
Recruitment status
Terminated
Funding source
This clinical trial will be done in collaboration with the State Pharmaceutical Manufacturing Cooperation and Sri Lanka Navy, Ministry of Defense
Regulatory approvals
National Medicines Regulatory Authority (Ref: CLITRI/2020/00032)
Status
Approved
Date of Approval
2020-05-03
Approval number
P/22/04/2020
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Kelaniya. |
| Institutional Address: | P.O.Box 6 Thalagolla Road, Ragama, Sri Lanka |
| Telephone: | +94 11 2961267 |
| Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Niriella MA
Professor in Gastroenterology
Department of Medicine,
Faculty of Medicine, University of Kelaniya
P.O.Box 6
Thalagolla Road
Ragama
+94 11 2961000
+94 71 4820948
+94 11 2958337
maduniln@yahoo.co.uk
https://medicine.kln.ac.lk/index.php/prof-m-a-niriella.html
Contact Person for Public Queries
Niriella MA
Professor in Gastroenterology
Department of Medicine,
Faculty of Medicine, University of Kelaniya
P.O.Box 6
Thalagolla Road
Ragama
+94 11 2961000
+94 71 4820948
+94 11 2958337
maduniln@yahoo.co.uk
https://medicine.kln.ac.lk/index.php/prof-m-a-niriella.html
Primary study sponsor/organization
Department of Medicine, Faculty of Medicine, University of Kelaniya
P.O.Box 6
Thalagolla Road
Ragama,
Sri Lanka
+94 11 2961000
+94 11 2958337
https://medicine.kln.ac.lk/depts/medicine/
Secondary study sponsor (If any)
State Pharmaceuticals Manufacturing Corporation (SPMC), Sri Lanka
No.11, Sir John Kotelawala Mawatha,
Kandawala Estate,
Ratmalana,
Sri Lanka
(+94) 011 2636966
(+94) 011 2634771
spmclanka@sltnet.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data which is used to generate results will be shared immediately following publication after de-identification (text, tables, figures and appendices). Study protocol, statistical analysis plan and analytic code will be made available. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared to achieve the aims in an approved proposal. Proposals should be directed to maduniln@yahoo.co.uk. To gain access, data requestors will need to sign a data access agreement.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
