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: pactr.samrc.ac.za
Trial no.: PACTR202108891693522 Date of Approval: 19/08/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Does the addition of Hydroxychloroquine HCQ and Azithromycin enhance the effect of Ivermectin against Covid 19 infection?
Official scientific title A COMPARATIVE RANDOMIZED CLINICAL TRIAL OF IVERMECTIN VERSUS HYDROXYCHLOROQUINE, IVERMECTIN, AND AZITHROMYCIN(HIA TRIPLE THERAPY) IN COVID- 19 IN NIGERIA.
Brief summary describing the background and objectives of the trial Authors:Babalola OE Ndanusa Y A Ogedengbe J O Thairu Y Omede O The Objective of the research is to investigate the added benefits of HIA triple therapy to Ivermectin (if any) in the management of Covid 19 in NigeriaSeveral research publications have established the effectiveness and safety of Ivermectin (refs) There also appears to be some evidence, mostly anecdotal, that certain other drugs, in widespread use in Nigeria, also have a place in Covid 19 therapy.The study was designed as a double blind prosepctive randomised control trial The objective was to recruit 30 candidates in two arms of the study Arm A will be treated with Ivermectin plus Supportive therapy Arm B will be treated with Ivermectin plus HIA triple therapy.Proportion virologically negative by days 2, 5, 14 and 21 in each arm, other virology outcomes Effect on Platelet count and inflammatory markers Time to discharge from care. Time to resolution of symptoms. Serious adverse events.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Abujacovid
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Covid 19
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2021
Actual trial start date 15/05/2021
Anticipated date of last follow up 01/07/2021
Actual Last follow-up date 07/07/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 61
Recruitment status Completed
Publication URL www.abujacovid.com
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Drugs Ivermectin IVM IVM 200mcg/kg X 5 days Five days IVM The control group is labelled group A. Group A will be given IVM in the doses indicated above. 30 Active-Treatment of Control Group
Experimental Group Ivermectin IVM Hydroxychloroquine HCQ Azithromycin AZT IVM 200mcg/kg for five days HCQ 200mg stat, then 100mg bd X three days AZT 500mg stat 250mg daily X 3 days IVM for five days HCQ for 4 days AZT for three days Drug intervention triple therapy 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Newly diagnosed cases of Covid 19 virologically confirmed Pregnant Breastfeeding Allergy to drugs 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 80 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
Yes 28/10/2020 University of Abuja Teaching Hospiral HREC
Ethics Committee Address
Street address City Postal code Country
UATH GWAGWALADA Gwagwalada 902291 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion virologically negative by days 2, 5, 14 and 21 in each arm, other virology outcomes days 1-14, 21 especially days 2,5,14
Secondary Outcome Effect on Platelet count and inflammatory markers Time to discharge from care. Time to resolution of symptoms. Serious adverse events. SPO2 changes over time For SPO2. daily measurements. For others, Baseline and day 5. Resolution of symptoms will be assessed on a daily basis.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Abuja Teaching Hospital Hospital road, Gwagwalada Gwagwalada 902101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Central Bank of Nigeria HSRDIS Samuel Ladoke Akintola Street, P.M.B, 187 Samuel Ladoke Akintola Boulevard, Abuja Abuja 900108 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Rachel eye Center 23 Onitsha crescent, Garki II Abuja Box 4908 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr. Thairu Yunusa Department of Medical Microbiology, University of Abuja, Abuja, Nigeria Gwagwalada 90221 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator John Ogedengbe johnogedengbe@gmail.com +2348036587356 Department of Human Physiology, University of Abuja
City Postal code Country Position/Affiliation
Gwagwalada 90221 Nigeria Senior lecturer
Role Name Email Phone Street address
Scientific Enquiries Olufemi Babalola bablo57@gmail.com +2348098603395 23 Onitsha crescent Garki II
City Postal code Country Position/Affiliation
Abuja BOX 4108 Nigeria ProfessorEpidemiologist
Role Name Email Phone Street address
Public Enquiries Yahaya Abdullahi Ndanusa yndanusa@gmail.com +2348170440500 B43 CBN Executive Estate, Karu Abuja.Karu Abuja
City Postal code Country Position/Affiliation
Abuja Nigeria Medical Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data will be made available, including data dictionaries. All data will be shared but individual identification will be redacted. Study protocol, statistical analysis plan, informed consent form , clinical study report and analytic code will be made available. Data will be made available immediately after publication with no end date. Anyone who wishes to can access the data for whatever purpose they wish. Data will be made available indefinitely. Informed Consent Form,Study Protocol As soon as we have published It is open to anyone who wished to see the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.abujacovid.ng.com 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