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.: PACTR202010472402152 Date of Approval: 09/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COVADIS study
Official scientific title COVID-19 Epidemic in West Africa (WA): infection dynamics and diagnostic approaches
Brief summary describing the background and objectives of the trial Overall Objective The overall aim is to contribute to the COVID-19 response in WA by improving local diagnostic and surveillance capabilities. Specific Objectives 1. To validate a commercially available antigen-based rapid diagnostic test in suspected COVID-19 patients; 2. To develop a validated serology platform for determining serostatus and monitoring immune responses to SARS-CoV-2 infection; 3. To characterize the viral load and antibodies dynamics in a cohort of confirmed COVID-19 patients; 4. To characterize at household level the sero-epidemiology of COVID-19 infections. 5. To determine the performance of saliva for the detection of SARS-CoV-2 RNA and antibodies in COVID-19 patients; 6. To monitor the duration and infectivity of viral shedding in NPS, saliva, urines, and stools in COVID-19 infected patients for up to 6 months after onset of symptoms; In order to complete objectives 5 & 6 additional funds will be sought. However, these samples will be collected during the patients’ cohort follow-up and stored at -80°C until further processed.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) COVADIS
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 12/10/2020
Actual trial start date
Anticipated date of last follow up 30/04/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 1100
Actual target sample size (number of participants)
Recruitment status Active, not 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 Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Covid test kit NA NA This is an observational study 100
Control Group PCR NA NA Covid PCR test 1000 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults and children of both genders without age limit being either suspect of COVID-19, or contacts of a confirmed COVID-19 patient following the WHO case definitions below, are eligible to participate in the study - The subject (or parents/guardians for minors<18y) has not provided individual informed consent for the study; - The patient has already been sampled and is waiting for the results; 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 12 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 27/07/2020 The Gambia Government MRC Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Atlantic Road Fajara Banjul 00220 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. To validate a commercially available antigen-based rapid diagnostic test in suspected COVID-19 patients; 2. To develop a validated serology platform for determining serostatus and monitoring immune responses to SARS-CoV-2 infection; 3. To characterize the viral load and antibody dynamics in a cohort of confirmed COVID-19 patients; 4. To characterize at household level the sero-epidemiology of COVID-19 infections; 5. To determine the performance of saliva for the detection of SARS-CoV-2 RNA and antibodies in COVID-19 patients; 6. To determine the duration and infectivity of viral shedding in COVID-19 patients; End of trial participation
Secondary Outcome To contribute to the COVID-19 response in WA by improving local diagnostic and surveillance capabilities. point of care
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MRCG at LSHTM Atlantic Road Fajara Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Anna van Saksenlaan 51 2593 HW The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Council Unit The Gambia at LSHTM Atlantic Road Banjul Gambia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Annette Erhart Annette.Erhart@lshtm.ac.uk 00220449442 Fajara
City Postal code Country Position/Affiliation
Banjul Gambia Coordinator
Role Name Email Phone Street address
Public Enquiries Vivat Thomas Njie vthomas@mrc.gm 002204495442 Fajara
City Postal code Country Position/Affiliation
Banjul Gambia Department of Clinical Trials Coordinator
Role Name Email Phone Street address
Scientific Enquiries Bakary Conteh bconteh@mrc.gm 002204495442 Fajara
City Postal code Country Position/Affiliation
Banjul Gambia Research Clinician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individually every recruited participant will be sampled for NDP and/or OPS and blood for PCR. Results will be collected using a dedicated database. This will be shared as part of the IPD sharing requirement. Clinical Study Report,Informed Consent Form,Study Protocol IPD shall be shared at the end of the study. The PI for this trial decides who get the data after a formal request. But generally we will give open access to generated data.
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