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.: PACTR202102588777597 Date of Approval: 12/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ivermectin Treatment Trial (ITT)
Official scientific title A Multi-Center, Open- Label, Randomized, Controlled Clinical Trial of the Efficacy of Ivermectin for the Treatment and Prophylaxis of COVID-19
Brief summary describing the background and objectives of the trial This randomized, open-label, controlled clinical trial will evaluate the efficacy of therapeutic agents in the treatment and prophylactic therapy of adults with lab positive COVID-19 and their household contacts respectively: All study subjects will receive: Arm 1 – Ivermectin with standard therapy; Arm 2 – standard therapy only
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 02/02/2021
Actual trial start date 03/02/2021
Anticipated date of last follow up 17/04/2021
Actual Last follow-up date 03/02/2022
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ivermectin 0.2 mg/kg/day Days 1 and 3 Tablets 120
Control Group Standard of Care Augmentin 650mg tablets 12hhrly for 24hrs or Augmentin IV 1g q 24 hours • Zinc sulphate tablets 100mg daily • Calcium tablets 300mg daily • Vitamin C tablets 1g daily • Vitamin D tablets 50mcg daily 10 days Tablets (possibly injection for Augmentin) 120 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) Provide written informed consent prior to initiation of any study procedures (2) Understand and agree to comply with planned study procedures (3) Agree to the collection of oropharyngeal swabs and venous blood per protocol (4) Be male or non-pregnant female adult ≥18 years of age at time of enrolment (5) Have laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen no more than 72 hours prior to randomisation. 1. American Society of Anaesthesiologists (ASA) class 3 and above. 2. Stage 4 severe chronic kidney disease or requiring dialysis (eGFR < 30) 3. Pregnant or breast feeding. 4. Anticipated transfer to another facility which is not a study site within 72 hours. 5. Participants with known haematological diseases (G6PD deficiency) 6. Participants with chronic liver and kidney disease and reaching end-stage. 7. Participants with arrhythmia and chronic heart disease. 8. Participants known to have retinal disease or hearing loss. 9. Participants known to have a mental illness. 10. Skin disorders (including rash, dermatitis, psoriasis). 11. Allergy to Ivermectin or its analogues. 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) 18 Year(s) 85 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 28/01/2021 LAGOS STATE UNIVERSITY TEACHING HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi Way Ikeja 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality Day 7
Secondary Outcome 1. Resolution of symptoms assessed by clinical status and daily NEWS score until discharge and on ; 2. SARS-CoV-2 clearance time 1. Day 7 2. Days 1, 4 and 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mainland Hospital 1, Mainland Hospital Drive Yaba Nigeria
Federal Medical Centre Olabisi Onabanjo Way Idi-Aba Abeokuta Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
LAGOS STATE GOVERNMENT State Secretariat Alausa Ikeja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor LAGOS STATE MINISTRY OF HEALTH State Secretariat Alausa Ikeja Nigeria Government
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Akin Osibogun akinosibogun@yahoo.co.uk +2348023220250 Ishaga Road Idi-Araba
City Postal code Country Position/Affiliation
Lagos Nigeria Professor of Public Health
Role Name Email Phone Street address
Principal Investigator Akin Abayomi profakinabayomi@gmail.com +2349031101982 State Secretariat
City Postal code Country Position/Affiliation
Alausa Ikeja Nigeria Honourable Commissioner for Health
Role Name Email Phone Street address
Scientific Enquiries Olufemi Erinoso olufemierinoso@gmail.com +2348021203027 1-5 Oba Akinjobi Way
City Postal code Country Position/Affiliation
Ikeja Lagos Nigeria Senior Registrar in MaxilloFacial Surgery LASUTH
Role Name Email Phone Street address
Public Enquiries Hussein AbdurRazzaq haderazz05@ymail.com +2348099355417 State Secretariat
City Postal code Country Position/Affiliation
Alausa Ikeja Nigeria Head Health Research Unit
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data that underlie the results of the study after deidentification. Study Protocol Beginning 9 months and ending 36 months after the publication of the study Outside investigators upon scientific review of the merits of their proposed research plan.
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