Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19

NCT04359537 | Unknown Phase 2 DMC

• 1 other identifier: F.1-1/2015/ERB/SZABMU/549
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Hydroxychloroquine has been approved by FDA as one of the treatment options for COVID 19.Healthcare personnel are amongst those at highest risk to contract the disease. Several health authorities are now recommending the use of hydroxychloroquine as pre-exposure prophylaxis is in health care personnel. Several studies are on going in this context. However there is a controversy regarding the dosage regimen. This drug has a half life of 22.4 days. In this study we will be comparing three different doses of Hydroxychloroquine and additionally have a control group in order to determine the efficacy of hydroxychloroquine as pre- exposure prophylaxis in healthcare personnel in various doses.

Conditions

COVID 19

Keywords

pre-exposure prophylaxis; Healthcare personnel

Outcome Measures

Primary Outcomes (1)

• COVID-19-free survival in experimental arms compared to placebo

  Outcome reported as the percentage of participants in each arm who are COVID-19-free at the end of study treatment

  12 weeks

Secondary Outcomes (6)

• Incidence of confirmed SARS-COV-2 detection

  12 weeks

• Incidence of possible COVID-19 symptoms

  12 weeks

• Incidence of all-cause study medicine discontinuation

  12 weeks

• Ordinal Scale of COVID-19 Disease maximum severity if COVID-19 diagnosed at study end

  12 weeks

• Incidence of Hospitalization for COVID-19 or death

  12 weeks

Study Arms (4)

Arm 1

EXPERIMENTAL

Hydroxychloroquine Sulphate will be administered at a dose of 400mg twice a day on day 1 followed by 400 mg once a week for a total of 12 weeks

Drug: Hydroxychloroquine Sulfate 200 MG

Arm 2

EXPERIMENTAL

Hydroxychloroquine Sulphate will be admoinistered at a dose of 400 mg on day 1 followed by 400mg once every 3 weeks for at total of 12 weeks

Drug: Hydroxychloroquine Sulfate 200 MG

Arm 3

EXPERIMENTAL

Hydroxychloroquine Sulphate will be administered at a dose of 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks

Drug: Hydroxychloroquine Sulfate 200 MG

Arm 4

PLACEBO COMPARATOR

Control group will recieve Placebo 200mg on day 1 followed by Placebo 200mg every three weeks for 12 weeks

Other: Placebo

Interventions

Hydroxychloroquine Sulfate 200 MG DRUG

Hydroxychloroquine Sulphate 200 mg tablets will be prescribed and instituted orally at the doses and regimens described

Also known as: Tab HCQ

Arm 1; Arm 2; Arm 3

Placebo OTHER

Control group will receive a Placebo tablet. Placebo 200mg will be given on Day 1 followed by Placebo 200mg every three weeks.

Arm 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A healthcare worker at high risk for COVID19 exposure (defined below):
• Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel) ;
• Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists) ;
• Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists, gastroenterologists performing endoscopy, Pulmonologists performing bronchoscopy);
• First responders (i.e. EMTs, paramedics) ;
• Persons working in the departments of General Medicine, Pulmonology, Infectious disease and Isolation wards.

You may not qualify if:

• Active COVID-19 disease;
• Confirmed prior COVID-19 disease;
• Current fever, cough, shortness of breath;
• Contraindication or hypersensitivity to chloroquine or hydroxychloroquine ad hypersensitivity to 4-aminoquinoline compounds;
• Pregnancy;
• Lactation;
• Prior retinal eye disease;
• Known Chronic Kidney disease, Stage 4 or 5 or dialysis;
• Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency ;
• Weight \<40 kg;
• Current use of chloroquine,hydroxychloroquine or cardiac medicines like flecainide, amiodarone, digoxin, procainamide, or propafenone;
• Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen or methotrexate;
• Current use of medications causing QT interval prolongation like: macrolides,antipsychotics,quinolones,antihistamines,SSRIs,tricyclic antidepressants, antifungals;
• Recent Myocardial Infarction;
• History of Epilepsy

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Study Sites (1)

Shaheed Zulfiaqar Ali Bhutto Medical University

Islamabad, Federal Capital, 44000, Pakistan

RECRUITING

Related Publications (4)

• Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Sevestre J, Mailhe M, Doudier B, Aubry C, Amrane S, Seng P, Hocquart M, Eldin C, Finance J, Vieira VE, Tissot-Dupont HT, Honore S, Stein A, Million M, Colson P, La Scola B, Veit V, Jacquier A, Deharo JC, Drancourt M, Fournier PE, Rolain JM, Brouqui P, Raoult D. Clinical and microbiological effect of a combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients with at least a six-day follow up: A pilot observational study. Travel Med Infect Dis. 2020 Mar-Apr;34:101663. doi: 10.1016/j.tmaid.2020.101663. Epub 2020 Apr 11.

  PMID: 32289548 BACKGROUND

• Mack HG. Hydroxychloroquine use during the COVID-19 pandemic 2020. Aust J Gen Pract. 2020 Apr 14;49. doi: 10.31128/AJGP-COVID-08.

  PMID: 32294807 BACKGROUND

• Xiang YT, Jin Y, Wang Y, Zhang Q, Zhang L, Cheung T. Tribute to health workers in China: A group of respectable population during the outbreak of the COVID-19. Int J Biol Sci. 2020 Mar 15;16(10):1739-1740. doi: 10.7150/ijbs.45135. eCollection 2020.

  PMID: 32226292 BACKGROUND

• Khan S, Siddique R, Ali A, Bai Q, Li Z, Li H, Shereen MA, Xue M, Nabi G. The spread of novel coronavirus has created an alarming situation worldwide. J Infect Public Health. 2020 Apr;13(4):469-471. doi: 10.1016/j.jiph.2020.03.005. Epub 2020 Apr 2. No abstract available.

  PMID: 32247752 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

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

Study Officials

• Fibhaa Syed, FRCP

  Shaheed Zylfiqar Ali Bhutto Medical University

  PRINCIPAL INVESTIGATOR

• Mohammed Ali Arif, FRCP

  Shaheed Zulfiqar Ali Bhutto Medical University

  PRINCIPAL INVESTIGATOR

• Rauf Niazi, FRCP

  Shaheed Zulfiqar Ali Bhutto Medical University /PIMS

  STUDY DIRECTOR

Central Study Contacts

Fibhaa Syed, FRCP

CONTACT

+923335300002; drfibhasyed@szabmu.edu.pk

Mohammed Ali Arif, FRCP

CONTACT

+923335123701; mohammad_ali_arif@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistan Professor Medicine

Model Details: Participants fulfilling the eligibility criteria will be randomized to 4 arms by using Random Allocation Software version-2 Arm Intervention /treatment Experimental group 1: Hydroxychloroquine 400 mg twice a day 1,followed by 400 mg weekly for a total of 12 weeks Experimental group 2:Hydroxychloroquine 400 mg on day 1 followed by 400 mg once every 3 weeks for a total of 12 weeks Experimental group 3:Hydroxychloroquine 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks Control Group :Placebo 200mg will be given on day 1 followed by Placebo 200mg every three weeks for a total of 12 weeks..

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: May 1, 2020
• Primary Completion: August 25, 2020
• Study Completion: September 25, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)