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

04 May 2020

The date of last modification

May 04, 2020



Application Summary


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)


Trial Details


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

  1. All consenting male and female adult Naval personnel (18-59.9 years of age)

  2. Exposure to a patient with confirmed COVID-19 infection (rRT-PCR positive for SARS-CoV-2 virus)

  3. 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

  4. Recruited within 48 hours of admission to these centers

  5. Willing to take study drug as directed for 5 days.


Exclusion criteria

  1. Pregnant females

  2. 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)

  3. Presence of pre-existing cardiovascular disease including being on medication for ischaemic heart disease

  4. Presence of contraindication to the use of HCQ (on other medications predisposing to long QT or presence of long QT on baseline ECG)

  5. Prior diagnosis of retinopathy, G6PD, malignancy or advanced kidney disease

  6. 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


Date of study completion


Recruitment status

Pending


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)



State of Ethics Review Approval


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 & Sponsor Information


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

Trial Completion details


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