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.: PACTR202004801273802 Date of Approval: 08/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lagos COVID-19 Chloroquine Treatment Trial (LACCTT)
Official scientific title A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Efficacy and Safety of Chloroquine Phosphate, Hydroxychloroquine sulphate and Lopinavir/Ritonavir for the Treatment of COVID-19 in Lagos State.
Brief summary describing the background and objectives of the trial The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses. To evaluate the clinical efficacy and safety of therapeutic agents in the treatment of adults with lab positive COVID-19 in Lagos State: All study subjects will receive standard therapy with the following add-ons: Arm 1 - chloroquine phosphate; Arm 2 – hydroxychloroquine sulphate; Arm 3 – Lopinavir/ ritonavir and Arm 4 – placebo. There will be interim monitoring to allow early stopping for futility,
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 20/04/2020
Actual trial start date 15/06/2020
Anticipated date of last follow up 16/12/2020
Actual Last follow-up date 15/01/2021
Anticipated target sample size (number of participants) 800
Actual target sample size (number of participants)
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Chloroquine phosphate 500mg bd 7 days white, film-coated tablets 200
Experimental Group Hydroxychloroquine sulphate 400mg bd 7 days white, film-coated tablets 200
Control Group Chloroquine Placebo 2 tablets twice daily 7 days white, film-coated tablets 600 Placebo
Experimental Group LopinavirRitonavir 400mg/100mg bd 14 yellow, film-coated 200
Control Group Hydroxychloroquine placebo 2 tablets twice daily 7 days white, film-coated tablets 600 Placebo
Control Group LopinavirRitonavir placebo 2 tablets twice daily 14 days yellow, film-coated tablets 600 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 2. Understands and agrees to comply with planned study procedures. 3. Agrees to the collection of OP swabs and venous blood per protocol. 4. Male or non-pregnant female adult ≥18 years of age at time of enrolment. 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to randomisation. 6. Illness of any duration, and at least one of the following: 2.3.3 Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR 2.3.4 Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, OR 2.3.5 Requiring mechanical ventilation and/or supplemental oxygen. 7. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site). 1. ALT/AST > 5 times the upper limit of normal. 2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) 3. Pregnant or breast feeding. 4. Anticipated transfer to another hospital which is not a study site within 72 hours. 5. Patients with hematological diseases. 6.Patients with chronic liver and kidney disease and reaching end-stage. 7. Patients with arrhythmia and chronic heart disease. 8. Patients known to have retinal disease, hearing loss or hearing loss. 9. Patients known to have a mental illness. 10. Skin disorders (including rash, dermatitis, psoriasis). 11. Allergy to any study medication (4-aminoquinoline). Adult: 19 Year-44 Year 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 07/04/2020 LASUTH HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
1-5 OBA AKINJOBI ROAD IKEJA, LAGOS 23401 Nigeria
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 22/05/2020 LASUTH Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1, Oba Akinjobi Way, Ikeja Ikeja 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Status on 7-point ordinal scale Day 15
Secondary Outcome Time to negative SARS-CoV-2 Days 3, 5, 8, 11, 15, 29
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mainland Hospital 1, Mainland Hospital Drive Yaba Nigeria
Onikan Stadium Isolation Centre Tafawa Balewa Square Lagos Nigeria
EtiOsa Landmark Isolation Centre Water Corporation Drive, Victoria Island Lagos Nigeria
Lekki Isolation Centre Opposite Mega Chicken Lagos Nigeria
General Hospital Gbagada 1, Hospital Road, Gbagada Lagos Nigeria
Lagos State University Teaching Hospital 1, Oba Akinjobi Way, Ikeja GRA Ikeja Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor LAGOS STATE GOVERNMENT Obafemi Awolowo Way Ikeja Lagos 23401 Nigeria Government
COLLABORATORS
Name Street address City Postal code Country
Nigerian Institute of Medical Research 6, Edmund Crescent Yaba 23401 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Akin Abayomi profakinabayomi@gmail.com +2349031101982 Ministry of Health, State Secretariat, Obafemi Awolowo Way
City Postal code Country Position/Affiliation
Ikeja 23401 Nigeria Honourable Commissioner
Role Name Email Phone Street address
Public Enquiries Hussein AbdurRazzaq haderazz05@ymail.com +2348099355417 2, Jinadu Olusi Street
City Postal code Country Position/Affiliation
Ikorodu 100401 Nigeria Head of Health Research
Role Name Email Phone Street address
Scientific Enquiries Samuel Anya sea.anya@gmail.com +2347056416162 Plot 154 Aguiyi Ironsi Layout
City Postal code Country Position/Affiliation
Umuahia 23401 Nigeria Independent Consultant
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
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 08/04/2020 Regulatory requirement as pointed out by the reviewer No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 08/04/2020 Regulatory requirement as pointed out by the reviewer Individual Participant Data that underlie the results of the study after deidentification
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 08/04/2020 Regulatory requirement as pointed out by the reviewer Beginning 9 months and ending 36 months after the publication of the study
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 08/04/2020 Regulatory requirement as pointed out by the reviewer Outside investigators upon scientific review of the merits of their proposed research plan
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 08/04/2020 Regulatory requirement as pointed out by the reviewer Study Protocol
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 08/04/2020 edit A Single-Center, Single-blinded, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Chloroquine Phosphate therapy and Hydroxychloroquine therapy compared to only Standard Support Therapy for the Treatment of COVID-19 in Hospitalized Patients in Lagos State A Single-Center, Single-blinded, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Chloroquine Phosphate therapy and Hydroxychloroquine therapy compared to only Standard Support Therapy for the Treatment of COVID-19 in Hospitalized Patients in Lagos State
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 08/04/2020 edit The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses. The overall aim of this study is to evaluate the clinical efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate relative to only standard supportive therapy among hospitalized adult patients who have COVID-19 in Nigeria. The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses. The overall aim of this study is to evaluate the clinical efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate relative to only standard supportive therapy among hospitalized adult patients who have COVID-19 in Nigeria.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 08/04/2020 Protocol was updated A Single-Center, Single-blinded, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Chloroquine Phosphate therapy and Hydroxychloroquine therapy compared to only Standard Support Therapy for the Treatment of COVID-19 in Hospitalized Patients in Lagos State A Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Efficacy and Safety of Chloroquine Phosphate and Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients in Lagos State
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 08/04/2020 Protocol was updated The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses. The overall aim of this study is to evaluate the clinical efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate relative to only standard supportive therapy among hospitalized adult patients who have COVID-19 in Nigeria. The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses. To evaluate the clinical efficacy of chloroquine phosphate and hydroxychloroquine sulphate added-on to standard therapy relative to standard therapy alone for treatment of patients hospitalized with COVID-19
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 08/04/2020 Protocol was updated Control Group, Placebo, , 10 days, white, film-coated tablets, 136, Placebo Control Group, Placebo, , 10 days, white, film-coated tablets, 200, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 08/04/2020 Protocol was updated Experimental Group, Chloroquine phosphate, 500mg bd, 10 days, white, film-coated tablets, 136, Experimental Group, Chloroquine phosphate, 500mg bd, 10 days, white, film-coated tablets, 200,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 08/04/2020 Protocol was updated Experimental Group, Hydroxychloroquine sulphate, 400mg bd, 10 days, white, film-coated tablets, 136, Experimental Group, Hydroxychloroquine sulphate, 400mg bd, 10 days, white, film-coated tablets, 200,
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 08/04/2020 Full first name written Scientific Enquiries, Sam, Anya, Dr., sea.anya@gmail.com, , +2347056416162, Plot 154 Aguiyi Ironsi Layout, Umuahia, 23401, Nigeria, Independent Consultant Scientific Enquiries, Samuel, Anya, Dr., sea.anya@gmail.com, , +2347056416162, Plot 154 Aguiyi Ironsi Layout, Umuahia, 23401, Nigeria, Independent Consultant
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 22/06/2020 Protocol upgrade. Additional arm, sites. A Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Efficacy and Safety of Chloroquine Phosphate and Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients in Lagos State A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Efficacy and Safety of Chloroquine Phosphate, Hydroxychloroquine sulphate and Lopinavir/Ritonavir for the Treatment of COVID-19 in Lagos State.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 22/06/2020 Protocol upgrade. Additional arm, sites. The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses. To evaluate the clinical efficacy of chloroquine phosphate and hydroxychloroquine sulphate added-on to standard therapy relative to standard therapy alone for treatment of patients hospitalized with COVID-19 The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses. To evaluate the clinical efficacy and safety of therapeutic agents in the treatment of adults with lab positive COVID-19 in Lagos State: All study subjects will receive standard therapy with the following add-ons: Arm 1 - chloroquine phosphate; Arm 2 – hydroxychloroquine sulphate; Arm 3 – Lopinavir/ ritonavir and Arm 4 – placebo. There will be interim monitoring to allow early stopping for futility,
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 22/06/2020 Protocol upgrade. Additional arm, sites. 17 Apr 2020 20 Apr 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 22/06/2020 Protocol upgrade. Additional arm, sites. 15 Jun 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 22/06/2020 Protocol upgrade. Additional arm, sites. 16 Oct 2020 16 Dec 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 22/06/2020 Protocol upgrade. Additional arm, sites. 15 Jan 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 22/06/2020 Protocol upgrade. Additional arm, sites. 600 800
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 22/06/2020 Trial started Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Study Design Masking / blinding 22/06/2020 Protocol upgrade. Additional arm, sites. Care giver/Provider, Participants Outcome Assessors, Care giver/Provider, Participants
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 22/06/2020 protocol upgrade. Additional arm, sites. Experimental Group, LopinavirRitonavir, 400mg/100mg bd , 14, yellow, film-coated, 200,
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/06/2020 Additional site Onikan Stadium Isolation Centre, Tafawa Balewa Square, Lagos, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/06/2020 Additional site EtiOsa Landmark Isolation Centre, Water Corporation Drive, Victoria Island, Lagos, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/06/2020 Additional site Lekki Isolation Centre, Opposite Mega Chicken, Lagos, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/06/2020 Additional site General Hospital Gbagada, 1, Hospital Road, Gbagada, Lagos, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/06/2020 Additional site Lagos State University Teaching Hospital, 1, Oba Akinjobi Way, Ikeja GRA, Ikeja, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/06/2020 Protocol upgrade. Additional arm, sites TRUE, LASUTH Health Research Ethics Committee, 1, Oba Akinjobi Way, Ikeja, Ikeja, 23401, Nigeria, , 22 May 2020, 014710670, dcst@lasuth.org, 10928_11476_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/07/2020 Error in previous info entry Experimental Group, Chloroquine phosphate, 500mg bd, 7 days, white, film-coated tablets, 200,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/07/2020 Error in previous info entry Experimental Group, Hydroxychloroquine sulphate, 400mg bd, 10 days, white, film-coated tablets, 200, Experimental Group, Hydroxychloroquine sulphate, 400mg bd, 7 days, white, film-coated tablets, 200,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/07/2020 Incomplete previous entry Control Group, Chloroquine Placebo, 2 tablets twice daily, 7 days, white, film-coated tablets, 200, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/07/2020 Incomplete previous entry Control Group, Hydroxychloroquine placebo, 2 tablets twice daily, 7 days, white, film-coated tablets, 600, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/07/2020 Updated info Control Group, Chloroquine Placebo, 2 tablets twice daily, 7 days, white, film-coated tablets, 200, Placebo Control Group, Chloroquine Placebo, 2 tablets twice daily, 7 days, white, film-coated tablets, 600, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/07/2020 Incomplete previous info Control Group, LopinavirRitonavir placebo, 2 tablets twice daily, 14 days, yellow, film-coated tablets, 600, Placebo