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.: PACTR202102848675636 Date of Approval: 11/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Double Blind, Community-based, Randomized Controlled Trial on the Use of Ivermectin as Post Exposure Chemo-prophylaxis for COVID-19 among High Risk Individuals in Lagos (IVERPEPCOV) COVID-19
Official scientific title Double Blind, Community-based, Randomized Controlled Trial on the Use of Ivermectin as Post Exposure Chemo-prophylaxis for COVID-19 among High Risk Individuals in Lagos (IVERPEPCOV) COVID-19
Brief summary describing the background and objectives of the trial Study Description: A double blind randomized control study on the clinical benefits of the use of 200 mcg/kg/week for four weeks as a post-exposure chemo-prophylaxis among high risk individuals within the community. Objectives: The purpose of this study is to examine the efficacy and safety of Ivermectin in the prevention of COVID 19 following exposure and to determine the number of participants who will develop clinical COVID-19. Secondary objectives: To determine the number with serious adverse outcome within the study period and those that will develop severe or critical COVID-19 Endpoints: To demonstrate the efficacy and safety of various dosage regime of Ivermectin at 200mcg/kg/week for 4 weeks, 200mcg/kg alternate week for 2 doses, and 200mcg/kg once a month for 3 months, in the prevention of COVID-19 following exposure to SARS-CoV-2. . Secondary Endpoints: To determine the development of clinical defining symptoms in participants. Those who may develop serious adverse outcome within the study period Those who may develop severe or critical COVID-19 Secondary endpoints like assay for inflammatory markers such as D-dimer, CRP, FDP, Beta 2 macroglobulin. Study Population:The sample size calculated is 2000. Both genders, aged 18 years and above will be recruited. Description of Sites/Facilities Enrolling Participants: The study site will be Lagos University Teaching Hospital(LUTH) and identified COVID-19 hotspot communities in Lagos state. Individuals who test negative to RT-PCR and had contact with a COVID-19 patient in the last 4 days Description of Study Intervention: The study will involve the administration of oral tablets of ivermectin at 200mcg/kg/week) for 4 weeks and as stated above to any consenting designated high-risk individuals such as
Type of trial RCT
Acronym (If the trial has an acronym then please provide) B
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Prevention
Anticipated trial start date 01/03/2021
Actual trial start date 08/03/2021
Anticipated date of last follow up 30/09/2021
Actual Last follow-up date 31/10/2021
Anticipated target sample size (number of participants) 2100
Actual target sample size (number of participants) 2000
Recruitment status Not yet recruiting
Publication URL www.npmcnjonline.org
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IVERMECTIN GROUP A-200mcg/kg/week for 4 weeks, GROUP B-200mcg/kg alternate week for 2 doses, GROUP C-200mcg/kg once a month for 3 months GROUP A- 4 WEEKS GROUP B- 4 WEEKS GROUP C- 3 MONTHS To demonstrate the efficacy and safety of various dosage regime of Ivermectin at 200mcg/kg/week for 4 weeks, 200mcg/kg alternate week for 2 doses, and 200mcg/kg once a month for 3 months, in the prevention of COVID-19 following exposure to SARS-CoV-2. 1000
Control Group Placebo 200mcg/kg/week for 4 weeks, 200mcg/kg alternate week for 2 doses, 200mcg/kg once a month for 3 months. GROUP D- 4 WEEKS GROUP E- 4 WEEKS GROUP F-3 MONTHS To demonstrate the efficacy and safety of various dosage regime of Ivermectin versus placebo effect in the prevention of COVID-19 following exposure to SARS-CoV-2. 1000 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years and above. 4. Close contacts (6 meters with no PPE) to confirmed RT-PCR positive individual. 5. Ability to take oral medication and be willing to adhere to the study regimen 6. For females of reproductive potential: a negative pregnancy test and LMP date. 7. Agreement to adhere to Lifestyle Considerations throughout study duration. 1. Current use of cytochrome P4 enzyme inducers such as azole group of oral antifungal medication (Ketoconazole, Itraconazole), Warfarin 2. Non exposure to Covid-19 patients 3. Those who refuse to give informed consent 4. Pregnant and lactating women will be excluded because Ivermectin is known to cross the blood placenta barrier and its effect on the unborn fetus has not been fully evaluated. Although there is no evidence of teratogenicity in the literature, the doses envisaged will be higher than that used in management of onchocerciasis. Safety first is our mantra. 5. Those with a known hypersensitivity to Ivermectin. 6. Those subjects who have had treatment with any investigational drug within 2 weeks prior to randomization. 7. Children, stigmatized population, institutionalized persons, Previously diagnosed and recovered from COVID-19. 8. Severely ill patients such as patients on ventilators, hepatic or renal impairment or unconscious. 9. Patients on known drugs that can have serious interactions with the trial drug including barbiturates (such asphennobarbital, butalbital), benzodiazepines (such as clonazepam, lorazepam), sodiumoxybate (GHB), valporic acid and herbal medicines 10. Treatment with another investigational drug. 80 and over: 80+ 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 08/02/2021 LAGOS UNIVERSITYTEACHING HOSPITAL HEALTH RESEARCH AND ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
ROOM 107, 1ST FLOOR, ADMINISTRATION BLOCK, LUTH COMPOUND LAGOS 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The purpose of this study is to examine the efficacy and safety of Ivermectin in the prevention of COVID 19 following exposure and to determine the number of participants who will develop clinical COVID-19. 1)The Primary outcome measure is the onset of clinical disease(symptoms such as Fever ,Cough, Sore Throat, Myalgia, Diarrhea, Shortness of Breath within 14 days after enrollment. subsequently confirmed by RT-PCR(New infection) 2).Number developing COVID-19 clinical disease 14 days after enrollment
Secondary Outcome 1)The number with serious adverse outcome within the study period 2)Number developing severe or critical COVID-19 End of the study period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAGOS UNIVERSITY TEACHING HOSPITAL IDI-ARABA, LAGOS LAGOS 120003 Nigeria
MUSHIN COMMUNITY MUSHIN LOCAL GOVERMENT AREA LAGOS 120003 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
PROF OLUFEMI BABALOLA 23, Onitsha Crescent, Off Gimbiya Street, Garki Abuja ABUJA 91003 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FEDERAL GOVERMENT OF NIGERIA ASO ROCK ABUJA ABUJA Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
LAGOS UNIVERSITY TEACHING HOSPITAL IDI-ARABA, LAGOS STATE 12003 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator OLUFEMI BABALOLA bablo57@gmail.com 08033894739 DEPARTMENT OF SURGERY, BINGHAM UNIVERSITY, KARU.
City Postal code Country Position/Affiliation
JOS Nigeria PROFESSOR
Role Name Email Phone Street address
Public Enquiries FELIX ALAKALOKO felixalakaloko@gmail.com 08034056897 DEPARTMENT OF SURGERY, LAGOS UNIVERSITY TEACHING HOSPITAL
City Postal code Country Position/Affiliation
LAGOS 12003 Nigeria CONSULTANT
Role Name Email Phone Street address
Scientific Enquiries ADESUYI AJAYI swiftsword09@gmail.com +18324060772 Baylor college of Medicine,Sugerland Estate, Houston-Texas, USA
City Postal code Country Position/Affiliation
TEXAS United States of America PROFESSOR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes: There is a plan to make IPD and related data dictionaries available and this will include all IPD that underlie results in a publication. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Between 6 months and 3 years after the completion of study Access criteria IPD and any additional supporting information will be shared by requesting directly through a mail to the PI on bablo57@gmail.com, this would be shared with anyone with a sound methodology and for general statistical analyses , mechanism of Information will be via direct e mail to the PI.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.npmcnjournal.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