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.: PACTR202102535686338 Date of Approval: 16/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Ivermectin for the Treatment and Prophylaxis of COVID-19 disease
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 study is a randomized, open-label, controlled clinical trial that will evaluate the efficacy of Ivermectin in the treatment and prophylactic therapy of adults with lab-positive COVID-19 and their household contacts respectively. All study subjects will receive either Ivermectin with standard therapy or standard therapy only. The study aims to evaluate the efficacy of ivermectin with the standard of care compared to standard of care only in the treatment of adults with lab positive COVID-19 disease. Further, the study aims to evaluate the effectiveness of ivermectin for the prevention of SARS-CoV-2 infection in RT-PCR Negative household contacts of hospitalized COVID-19 patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ITT
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Coronavirus disease 2019
Purpose of the trial Treatment: Drugs
Anticipated trial start date 22/02/2021
Actual trial start date
Anticipated date of last follow up 22/08/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral tablets Ivermectin Oral tablets Ivermectin 0.2mg/kg/day on days 1 and 3 with Standard of Care. Standard of Care include: Supplemental oxygen therapy immediately to patients with a severe acute respiratory infection (SARI) and respiratory distress, hypoxemia, or shock. Conservative fluid management in patients with SARI when there is no evidence of shock. Empiric antimicrobials to treat all likely pathogens causing SARI. Antimicrobials (Augmentin 650mg tablets 12hhrly for 24hrs or Augmentin IV 1g q 24 hours) within one hour of initial patient assessment for patients with evidence of URTI or sepsis. Zinc sulfate tablets 100mg daily Vitamin C tablets 1g daily Vitamin D tablets 50mcg daily days 1 and 3 after enrollment only (Participants enrolled for Treatment- Aim 1). 60 days for RT-PCR negative household contacts of laboratory positive COVID-19 cases (Participants enrolled for Prophylaxis- Aim 2) In the Ivermectin arm (Experiment arm) of the study, participants will receive an oral dose of ivermectin at 0.2 micrograms/kilogram for days 1 and 3 including standard of care. For example, a 75kg Adult will receive tablets of 15mg per dose. 120
Control Group Standard of care only Standard of Care - Supplemental oxygen therapy immediately to patients with a severe acute respiratory infection (SARI) and respiratory distress, hypoxemia, or shock. Conservative fluid management in patients with SARI when there is no evidence of shock. - Empiric antimicrobials to treat all likely pathogens causing SARI. Antimicrobials (Augmentin 650mg tablets 12hhrly for 24hrs or Augmentin IV 1g q 24 hours) within one hour of initial patient assessment for patients with evidence of URTI or sepsis. - Zinc sulfate tablets 100mg daily - Vitamin C tablets 1g daily - Vitamin D tablets 50mcg daily 7 days for laboratory positive COVID-19 cases at baseline (Participants enrolled for Treatment- Aim 1). 60 days for RT-PCR negative household-contacts of laboratory positive COVID-19 cases (Participants enrolled for Prophylaxis- Aim 2). In the control arm of the study, participants will receive standard of care for 7 days- and longer if indicated by the study physician. 120 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
In order to be eligible to participate in this study, a patient must meet all of the following criteria: (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 nasopharyngeal swabs, sputum, and venous blood per protocol (4) Be a male or non-pregnant female adult ≥18 years of age at the time of enrolment (5) Have laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen no more than 7 days prior to randomization OR be a household contact (within 7 days) of an individual with lab positive COVID-19 disease. An individual who meets any of the following criteria will be excluded from participation in this study: 1. Stage 4 severe chronic kidney disease or requiring dialysis (eGFR < 30) 2. Pregnant or breastfeeding. 3. Anticipated transfer to another facility that is not a study site within 72 hours. 4. Participants with known haematological diseases (G6PD deficiency) 5. Participants with chronic liver and kidney disease and reaching end-stage. 6. Participants with arrhythmia and chronic heart disease. 7. Participants known to have or hearing loss. 8. Participants known to have a mental disability. 9. Skin disorders (including rash, dermatitis, psoriasis). 10. Allergy to Ivermectin or its analogues. 11. Participants known to have filaria. 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) 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 28/01/2021 Lagos State University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1-3b Oba Akinjobi road, Ikeja, Lagos State Lagos 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary endpoint: 1. Mortality in both groups on day 7 2. Resolution of symptoms assessed by clinical status and daily NEWS score until discharge and on Day 7. 3. SARS-CoV-2 clearance time based on samples taken on Days 1, 4, and 6. Days 1, 2, 3, 4, 5, 6 and 7
Secondary Outcome Secondary endpoint: 1. Percentage of household contacts of hospitalized COVID-19 patients or other enrolled PCR Negative patients that received oral ivermectin that developed SARS-CoV-2 infection compared to household contacts or other enrolled PCR Negative patients that received no prophylactic therapy on or before day 60. 2. Time to onset of SARS-CoV-2 infection in household contacts of hospitalized COVID-19 patients or other enrolled PCR Negative patients that received oral ivermectin compared to those who received no prophylactic therapy, on or before day 60. days 1, 30 and 60
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mainland Infectious Disease Hospital Yaba Mainland Hospital Rd, Yaba 100001, Lagos Lagos 100001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Lagos State Government Lagos State Ministry of Health, Alausa, Ikeja Lagos 23401 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Lagos State Ministry of Health Alausa, Ikeja Lagos 23401 Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Global Vision Foundation 12108 Early Lilacs Path Clarksville, MD Maryland 21029 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Akin Osibogun akinosibogun@yahoo.co.uk +2348023220250 Hospital road, Idi-araba
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Professor of Public Health College of Medicine University of Lagos
Role Name Email Phone Street address
Public Enquiries Hussein Abdurrazzaq haderazz05@ymail.com 2348099355417 Secretariat road, Alausa, Ikeja
City Postal code Country Position/Affiliation
Lagos Nigeria Head Research Unit Lagos State Ministry of Health
Role Name Email Phone Street address
Scientific Enquiries Olufemi Erinoso olufemierinoso@gmail.com +2348021203027 1-3b Oba Akinjobi road, Ikeja
City Postal code Country Position/Affiliation
Lagos State Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie study results will be shared after de-identification (text, tables, figures, and appendices) Informed Consent Form,Study Protocol Beginning 9 months and ending 36 months after publication. Investigators who present a methodologically sound proposal and whose proposed use of the data has been approved by an independent review board.
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