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.: PACTR202006760881890 Date of Approval: 24/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lagos Covid-19 Convalescent Plasma Trial (LACCPT)
Official scientific title A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Clinical Trial of the Safety and Efficacy of Convalescent Plasma for the Treatment of COVID-19 in Hospitalized Patients in Lagos State
Brief summary describing the background and objectives of the trial This randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of Convalescent Plasma for the Treatment of COVID-19 in Hospitalized Patients in Lagos State: All study subjects will receive standard therapy with the following add-ons: Arm 1 – convalescent plasma infusion; Arm 2 – placebo infusion. A total of approximately 100 eligible subjects stratified 50:50 by the study sites of enrolment will be randomized in a 1:1 ratio to receive either convalescent plasma or placebo infusion. All research participants will be assessed for the following: • Clinical measures of safety and efficacy: Day 0 (baseline) to Day 11. • Serum antibody titre to SARS-CoV-2: Day (-1 or 0), 5, 8, 11, and 29 • SARS-CoV-2 RNA levels in fluid from nasopharyngeal or oropharyngeal swabs: Day (-1 or 0), 3, 5, 7, 9, & 11.
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: Other
Anticipated trial start date 01/08/2020
Actual trial start date 14/09/2020
Anticipated date of last follow up 30/11/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Convalescent Plasma 200ml x 2 1 day Straw-coloured infusion 50
Control Group Normal saline 200ml x 2 1 day Infusion of 0.5% normal saline with a straw-coloured agent (vitamin B-complex/ multivitamin) stored at room temperature 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A. Moderate to Severe COVID-19 disease cases 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 N-P, OP swabs, sputum 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 <7 days prior to randomization. 6. Illness of any duration, and at least one of the following: > 50% radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air OR requiring mechanical ventilation and/or supplemental oxygen. 7. If female of childbearing age, should 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. Pregnancy or breast feeding. 4. Anticipated transfer to another hospital which is not a study site within 72 hours. 5. Allergy to any study medication 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) 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 11/05/2020 LASUTH Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1, Oba Akinjobi Way, Ikeja GRA Lagos 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. SARS-CoV-2 detectable in NP, OP or sputum samples at days 1, 3, 5, 7, 9, & 11. 2. Clinical status of subject at day 11 (on a 7-point ordinal scale) • Not hospitalized, no limitations on activities • Not hospitalized, limitation on activities • Hospitalized, not requiring supplemental oxygen • Hospitalized, requiring supplemental oxygen • Hospitalized, on non-invasive ventilation or high flow oxygen devices • Hospitalized, on invasive mechanical ventilation • Death. Day 3, 5, 7, 9, and 11.
Secondary Outcome 1. Clinical status on Days 3, 5, 7, 9 & 11 2. Daily NEWS score until discharge or on Day 11 3. Duration of supplemental oxygen 4. Duration of mechanical ventilation 5. Duration of hospitalization 6. SARS-CoV-2 clearance time based on samples taken on Days 1, 3, 5, 7, 9, & 11 7. Cumulative incidence of treatment-related serious adverse reactions (SAR) categorized separately as either severe infusion reactions or Acute Respiratory Distress Syndrome (ARDS) during the study period 8. Cumulative incidence of treatment-related grade 3 and 4 adverse reactions (AR) during the study period up to and through Day 11 9. Changes in laboratory safety indices assessed on Days 1, 5, & 11 (except for D-dimer which will be assessed on days 1, 3, 5, 7, & 11) Days 3, 5, 7, 9 11
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mainland Hospital 1, Mainland Hospital Drive Yaba Nigeria
EtiOsa Isolation Centre Water Corporation Drive Lagos Nigeria
Onikan Isolation Centre Tafawa Balewa Square Lagos Nigeria
General Hospital Gbagada 1, Hospital Road Lagos Nigeria
Lagos University Teaching Hospital Ishaga road Lagos Nigeria
Lekki Isolation Centre Opposite Mega Chicken Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Lagos State Ministry of Health State Secretariat, Alausa Ikeja 23401 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Lagos State Government 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 Abayomi profakinabayomi@gmail.com +2349031101982 Block 4, State Secretariat, Alausa
City Postal code Country Position/Affiliation
Ikeja Nigeria Honourable Commissioner
Role Name Email Phone Street address
Public Enquiries Hussein AbdurRazzaq Hussein.abdur-razzaq@lagosstate.gov.ng +2348099355417 Block 4, State Secretariat, Alausa
City Postal code Country Position/Affiliation
Ikeja Nigeria Head Health Research
Role Name Email Phone Street address
Scientific Enquiries Bodunrin Osikomaiya bosikomaiya@gmail.com +23408163650375 58/60 Campbell Street
City Postal code Country Position/Affiliation
Lagos Island Nigeria Executive Secretary
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
Eligibility Age group 24/06/2020 edit Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 24/06/2020 edit A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Clinical Trial of the Safety and Efficacy of Convalescent Plasma for the Treatment of COVID-19 in Hospitalized Patients in Lagos State A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Clinical Trial of the Safety and Efficacy of Convalescent Plasma for the Treatment of COVID-19 in Hospitalized Patients in Lagos State
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 24/06/2020 Reviewer's comment. Lagos State Ministry of Health, State Secretariat, Alausa, Ikeja, 23401, Nigeria, Government Body,
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 24/09/2020 Updated protocol The study is a multi-center trial that will be conducted at the Lagos State Isolation Centers, Nigeria with a single Sponsor. The design was adapted to the World Health Organization Master Protocol for Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients. The study will compare a single investigational therapeutic agent (convalescent plasma) to a placebo, with both arms receiving standard supportive therapy. There will be interim monitoring to allow early stopping for futility, efficacy, or safety and to introduce new therapies as they become available. If one therapy proves to be superior to others in the trial, this treatment will then become the control arm for comparison(s) with new experimental treatment(s). This randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of Convalescent Plasma for the Treatment of COVID-19 in Hospitalized Patients in Lagos State: All study subjects will receive standard therapy with the following add-ons: Arm 1 – convalescent plasma infusion; Arm 2 – placebo infusion. A total of approximately 100 eligible subjects stratified 50:50 by the study sites of enrolment will be randomized in a 1:1 ratio to receive either convalescent plasma or placebo infusion. All research participants will be assessed for the following: • Clinical measures of safety and efficacy: Day 0 (baseline) to Day 11. • Serum antibody titre to SARS-CoV-2: Day (-1 or 0), 5, 8, 11, and 29 • SARS-CoV-2 RNA levels in fluid from nasopharyngeal or oropharyngeal swabs: Day (-1 or 0), 3, 5, 7, 9, & 11.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 24/09/2020 Updated protocol Phase-3 Phase-2
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 24/09/2020 Delayed commencement 30 Sep 2020 30 Nov 2020
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 24/09/2020 Updated protocol Simple randomization using a randomization table created by a computer software program
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 24/09/2020 Update 14 Sep 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 24/09/2020 Update Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 24/09/2020 Updated protocol Control Group, Normal saline, 200ml x 2, 1 day, Straw-coloured infusion, 50, Placebo Control Group, Normal saline, 200ml x 2, 1 day, Infusion of 0.5% normal saline with a straw-coloured agent (vitamin B-complex/ multivitamin) stored at room temperature, 50, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 24/09/2020 Updated protocol 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 NP, OP swabs, and sputum 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 RT-PCR, in any specimen < 72 hours prior to randomization. 6. Illness of any duration, and at least one of the following: • Radiographic infiltrates by imaging (chest x-ray, CT scan), or • Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or • 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). A. Moderate to Severe COVID-19 disease cases 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 N-P, OP swabs, sputum 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 <7 days prior to randomization. 6. Illness of any duration, and at least one of the following: > 50% radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air OR requiring mechanical ventilation and/or supplemental oxygen. 7. If female of childbearing age, should agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site)
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 24/09/2020 Updated protocol Primary Outcome, Percent of subjects with SARS-CoV-2 detectable in OP sampleat day 3, 5, 7, 9, and 11. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 6. Hospitalized, on invasive mechanical ventilation 7. Death. , Day 3, 5, 7, 9, and 11. Primary Outcome, 1. SARS-CoV-2 detectable in NP, OP or sputum samples at days 1, 3, 5, 7, 9, & 11. 2. Clinical status of subject at day 11 (on a 7-point ordinal scale) • Not hospitalized, no limitations on activities • Not hospitalized, limitation on activities • Hospitalized, not requiring supplemental oxygen • Hospitalized, requiring supplemental oxygen • Hospitalized, on non-invasive ventilation or high flow oxygen devices • Hospitalized, on invasive mechanical ventilation • Death., Day 3, 5, 7, 9, and 11.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 24/09/2020 Updated protocol Secondary Outcome, The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first , Daily while hospitalized and on day 15 Secondary Outcome, 1. Clinical status on Days 3, 5, 7, 9 & 11 2. Daily NEWS score until discharge or on Day 11 3. Duration of supplemental oxygen 4. Duration of mechanical ventilation 5. Duration of hospitalization 6. SARS-CoV-2 clearance time based on samples taken on Days 1, 3, 5, 7, 9, & 11 7. Cumulative incidence of treatment-related serious adverse reactions (SAR) categorized separately as either severe infusion reactions or Acute Respiratory Distress Syndrome (ARDS) during the study period 8. Cumulative incidence of treatment-related grade 3 and 4 adverse reactions (AR) during the study period up to and through Day 11 9. Changes in laboratory safety indices assessed on Days 1, 5, & 11 (except for D-dimer which will be assessed on days 1, 3, 5, 7, & 11), Days 3, 5, 7, 9 11