Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR202005622389003 Date of Approval: 28/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Hydroxychloroquine, Azithromycine and Zinc for the treatment of SARS-Cov2 infection in Senegal. COVID-19
Official scientific title Efficacy and safety of Hydroxychloroquine, Azythromycine and Zinc for the treatment of patients with SARS-Cov2 infection in Senegal: a dose ranging randomised trial. COVID-19
Brief summary describing the background and objectives of the trial In response to the current Coronavirus pandemic (SARS-Cov2), the World Health Organization (WHO) has advised the international scientific community to accelerate research and development of effective interventions that can accelerate the pandemic control. Several initiatives are currently under development but yet there are no approved therapeutic agents available for the SARS-Cov2. The current study will assess the efficacy and safety profile of two dosing regimens of Hydroxychloroquine with or without Azithromycin during the treatment of subjects infected with SARS-Cov2 in Senegal.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESHAZ Trial
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2020
Actual trial start date
Anticipated date of last follow up 15/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 384
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hydrochloroquine 600 mg plus Azythromycine Hydroxychloroquine: 600 mg daily for 6 days Azythromycine: 500 mg on day 1 followed by 250 mg daily from day2 to day 5 Hydroxychloroquine: 6 days Azythromicine: 5 days Hydroxychloroquine will be given on 3 times daily (200mg - 200 mg - 200 mg) during 6 days Azithromycine will be administered on a single daily dose: 500 mg the fisrt day forllowed by 250 mg from day2 to day 5 128
Experimental Group Hydroxychloroquine 400 plus Azythromycine. Hydroxychloroquine: 400 mg daily for 6 days (200 mg - 200 mg) Azythromicine: 500 mg on day 1 followed by 250 mg from day 2 to day 5 Hydroxychloroquine: 6 days Azythromicine: 5 days Hydroxychloroquine will be given on 2 times daily (200mg - 200 mg) during 6 days Azithromycine will be administered on a single daily dose: 500 mg the fisrt day forllowed by 250 mg from day2 to day 5 128
Control Group Zinc Zinc 20 mg daily and standard of care 6 days Control group 128 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(i) patients above the age of 18 with PCR confirmed covid19 infection less than 72 hours prior to randomisation,; (ii) absence danger signs such as respiratory distress requiring mechanical ventilation or supplemental oxygen encephalitic disorders, renal function failure; (iii) absence of known chronic illness. (i) Known allergy to any of the study medication; (ii) pregnancy or breastfeeding; (iii) ECG abnormality at admission; (iii) Patients with ALAT/ASAT higher than 3 times the upper limit of normal on admission; (iv) Patients with known chronic kidney diseases; (v) Patients with known retinal diseases. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 05/05/2020 Conseil National d Ethique et de Recherche en Sante
Ethics Committee Address
Street address City Postal code Country
MINISTERE DE LA SANTE ET DE L ACTION SOCIALE Dakar 4024 Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage of patients with undetectable viral load 7 days after treatment initiation. Day 7
Secondary Outcome Time to first PCR negative after treatment initiation. Week 1
Secondary Outcome Absolute and relative changes in biochemical parameters from baseline to day 7 after treatment initiation. Absolute and relative changes in haematological parameters from baseline to day 7 after treatment initiation. Proportion of participants with ECG abnormality after treatment initiation At baseline and at day 7 after treatment initiation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre for Epidemic Treatment Aerogare Yoff Health District of Yoff, Dakar Dakar 9999 Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
Division de la Lutte Contre le VIH et les IST Rue 1 x Blaise Diagne Dakar 7381 Senegal
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine University Cheikh Anta Diop of Dakar Senegal. Avenue Cheikh Anta Diop, PoBox 5005 Dakar Fann, Senegal. Dakar 5005 Senegal University
COLLABORATORS
Name Street address City Postal code Country
Prof Cheikh Tidiane NDOUR Fann Teaching Hospital Division of Infectious and Tropical Diseases Dakar Senegal
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roger TINE roger.tine@ucad.edu.sn +221338251998 Avenue Cheikh Anta Diop
City Postal code Country Position/Affiliation
Dakar 5005 Senegal Faculty of Medicine University Cheikh Anta Diop of Dakar
Role Name Email Phone Street address
Public Enquiries Cheikh T. NDOUR cheikh.ndour@ucad.edu.sn +221338691888 Avenue Cheikh Anta Diop
City Postal code Country Position/Affiliation
Dakar Senegal Fann Teaching Hospital Division of Infectious and Tropical Diseases
Role Name Email Phone Street address
Scientific Enquiries Roger TINE roger.tine@ucad.edu.sn +221338251998 Avenue Cheikh Anta Diop
City Postal code Country Position/Affiliation
Dakar 5005 Senegal Faculty of Medicine University Cheikh Anta Diop of Dakar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data generated from the trial will be stored on a data repository at UCAD and will be available to interested researchers. The data will be made avalaible within 6 months of study completion. Informed Consent Form,Statistical Analysis Plan,Study Protocol It is anticipated that IPD will be made avalaible within 6 months upon trial completion. The data will be made avalaible to any interested researcher upon request. Interested researchers should express their interest and need by adressing an official letter to the study PI describing why and what the intend to do with the IPD.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 18/05/2020 edit Hydroxychloroquine, Azithromycine and Zinc for the treatment of SARS-Cov2 infection in Senegal Hydroxychloroquine, Azithromycine and Zinc for the treatment of SARS-Cov2 infection in Senegal. COVID-19
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 18/05/2020 edit Efficacy and safety of Hydroxychloroquine, Azythromycine and Zinc for the treatment of patients with SARS-Cov2 infection in Senegal: a dose ranging randomised trial. Efficacy and safety of Hydroxychloroquine, Azythromycine and Zinc for the treatment of patients with SARS-Cov2 infection in Senegal: a dose ranging randomised trial. COVID-19
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 28/05/2020 Information on source of funding were missed during the initial submission of the trial registration. Following trial reviewer comments, we have updated this section. Division de la Lutte Contre le VIH et les IST , Rue 1 x Blaise Diagne, Dakar, 7381, Senegal, Government Body,
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 28/05/2020 The initial trail registration information did not include statement on IPD sharing. The section has been reviewed according to the trial review comment to meet this requirement. Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 28/05/2020 The initial trail registration information did not include statement on IPD sharing. The section has been reviewed according to the trial review comment to meet this requirement. The data generated from the trial will be stored on a data repository at UCAD and will be available to interested researchers. The data will be made avalaible within 6 months of study completion.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 28/05/2020 The initial trail registration information did not include statement on IPD sharing. The section has been reviewed according to the trial review comment to meet this requirement. It is anticipated that IPD will be made avalaible within 6 months upon trial completion.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 28/05/2020 The initial trail registration information did not include statement on IPD sharing. The section has been reviewed according to the trial review comment to meet this requirement. The data will be made avalaible to any interested researcher upon request. Interested researchers should express their interest and need by adressing an official letter to the study PI describing why and what the intend to do with the IPD.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 28/05/2020 The initial trail registration information did not include statement on IPD sharing. The section has been reviewed according to the trial review comment to meet this requirement. Study Protocol, Statistical Analysis Plan, Informed Consent Form