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.: PACTR202010718451278 Date of Approval: 19/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Factors affecting transmission of SARS-CoV-2 in Households of SARS-CoV-2 patients in Sub-Saharan Africa Ancillary study of the ANTICOV Study: An open-label, multicentre, randomised, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild / moderate cases of COVID-19
Official scientific title Factors affecting transmission of SARS-CoV-2 in Households of SARS-CoV-2 patients in Sub-Saharan Africa. COVID-19
Brief summary describing the background and objectives of the trial Control measures against COVID-19 in higher income countries have focused on physical distancing and lockdowns which have had success in reducing population transmission. However, in lower resourced countries with populations that live day by day, lockdown is unsustainable. Other measures to reduce transmission will need to be considered. Several therapies improve individual patient clinical outcomes through a variety of effects including inhibiting viral replication. By doing so, therapies may also reduce transmission. SARS-CoV-2 binds to ACE2 receptors in the upper and lower respiratory tract and cases can be very infectious. The basic reproduction number (Ro) of SARS-CoV-2 has been estimated as between 2-5 in data from high intensity outbreak zones , higher than influenza for instance (Ro 1.3) possibly because of pre-symptomatic transmission, high viral load in upper respiratory tract and possibly prolonged shedding , as well as an immunologically naive population. To date, COVID-19 has not been reported as frequently as feared in Africa, suggesting that the Ro may be currently lower than reported in outbreak zones. Reasons for this are not clear since other respiratory viruses such as influenza seem to have as high burden in the African region as elsewhere. Drug therapy of COVID-19 patients with mild/moderate disease, may prevent progression to severe disease, but may also reduce the viral load in the upper respiratory tract, the duration of symptoms and the duration of virus shedding. In turn, this would be expected to reduce transmission to contacts. Understanding risks for household transmission and role of drugs with antiviral activity in reducing this burden will be very important in the near future, since if case numbers rise, mild/moderate cases may no longer be isolated in facilities, and these data therefore will feed directly into policy on how best to control COVID-19 in different settings.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ANTICOV EPI
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 02/11/2020
Actual trial start date
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 1500
Actual target sample size (number of participants)
Recruitment status Completed
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 Dynamic (adaptive) random allocation such as minimization Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Paracetamol One to two tablets every 4-6 hours as required, to a maximum of 6 tablets (3 grams) daily in divided doses up to 14 days oral route 200 Active-Treatment of Control Group
Experimental Group Hydroxychloroquine Day 1: loading dose of 800 mg daily, divided into two daily intakes of 400 mg taken 12 hours apart Day 2-7: maintenance dose of 400 mg daily, divided into two daily intakes of 200 mg taken 12 hours apart 7 days Oral route 200
Experimental Group Lopinavir Ritonavir Day 1: loading dose of lopinavir 1600 mg / ritonavir 400 mg daily, divided into two daily intakes of lopinavir 800 mg / ritonavir 200 mg taken 12 hours apart Day 2-14: maintenance dose of lopinavir 800 mg / ritonavir 200 mg daily, divided into two daily intakes of lopinavir 400 mg / ritonavir 100 mg taken 12 hours apart 14 days Oral route 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For Index Cases (treated patients from the ANTICOV Study) 1. Comes from household in accessible area 2. At least 1 Household Contact (HHC) currently residing at household with index 3. Contact details of HHC provided by index case 4. Majority (over 50%) of HHC provide consent and enrol in the ANTICOV-EPI study 5. Randomised to ANTICOV For Household contacts (not treated patients living with the Index patient) 6. Member of same household as index case (household defined as sharing same cooking area) during the conduct of the study 7. Resides in household with index case before index case illness onset. 8. Majority (over 50%) of HHC provide consent and enrol in the ANTICOV-EPI study Exclusion criteria of household contacts 1. Inability to provide consent 2. Majority of all contacts of index in household do not enroll 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Month(s) 100 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 14/09/2020 KEMRI Scientific and Ethics Review Unit SERU
Ethics Committee Address
Street address City Postal code Country
PO BOX 54840 00200 Nairobi Kenya nairobi 54840 Kenya
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 22/07/2020 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Research and Development Division Ghana Health Service PO Box MB 190 Accra 190 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 12/08/2020 Comite Nacional de Bioetica Para saude
Ethics Committee Address
Street address City Postal code Country
Ministero da Saude 2 andar dto Av Eduardo Mondlane Salvador Allende Maputo 264 Mozambique
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 27/07/2020 Equatorial Guinea National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
CENGE office Viviendas Sociales of Sipopo Block 8 Portal 2 Malabo none Equatorial Guinea
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) Seroconversion for SARS-CoV-2 IgM, IgA and IgG among household contacts and index case Day 1, Day 14, Month 1 visits
Primary Outcome 2) RT-PCR SARS-CoV-2 positive results at Day 1 (index case)/D2(household contacts), 7, 14, 21, and Month 1 in household contacts and index case. Day 1, 7, 14, 21 and Month 1
Primary Outcome 3) Secondary attack rate of infection and illness for household contacts from index cases all visits
Secondary Outcome 1) Mild, moderate and severe COVID-19 disease individual outcomes in household contacts all visits
Secondary Outcome 2) Sequence of SARS-CoV-2 in RT-PCR positive samples all visits
Secondary Outcome 3) Quantitative measure of viral load as measured by Ct values in RT-PCR All visits
Secondary Outcome 4) Quantitative levels of antibodies (IgM, IgG, IgA) against SARS-CoV-2. Day 1, Day 14 and Month 1 visits
Secondary Outcome 5) Quantitative levels of antibodies (IgM, IgG, IgA) against other coronaviruses circulating in participating countries Day 1, Day 14, Month 1 visits
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Komfo Anokye Teaching Hospital Okomfo Anokye Road, Kumasi, Ghana Kumasi Ghana
Centro de Investigacao e Treino em Saude da Polana Canico CISPOC Rua da Costa do Sol, Polana, Canico Maputo Mozambique
Kenyatta University Teaching Referral and Research Hospital KUTRRH Northern Bypass Rd Kahawa West Nairobi PO Box 7674 00100 GPO Nairobi Nairobi Kenya
Malabo Clinical Research Center Rotunda Arab Malabo Equatorial Guinea
FUNDING SOURCES
Name of source Street address City Postal code Country
DNDi 15 Chemin Louis Dunant Geneva 1202 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DNDi 15 Chemin Louis Dunant Geneva 1202 Switzerland NGO
Primary Sponsor Ifakara Health Institute 463 Kiko Avenue Dar es Salaam 78373 Tanzania Institute
Primary Sponsor BERNHARD NOCHT INSTITUTE FOR TROPICAL MEDICINE Bernhard Nocht Strasse 74 Hamburg 20359 Germany Institute
Primary Sponsor ISGlobal IBarcelona Institute for Global Health Hospital Clinic Universitat de Barelona Carrer Rossello 132 Barcelona 08036 Spain Institute
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nathalie Strub Wourgaft nstrub@dndi.org 0041229069246 15 chemin Louis Dunant
City Postal code Country Position/Affiliation
Geneva 1202 Switzerland NTD Director
Role Name Email Phone Street address
Public Enquiries James Arkinstall media@dndi.org 0041229069230 15 chemin Louis Dunant
City Postal code Country Position/Affiliation
Geneva 1202 Switzerland Head of Communication and Advocacy
Role Name Email Phone Street address
Scientific Enquiries MarcAlain Widdowson mawiddowson@itg.be 003232476666 Kronenburgstraat 43
City Postal code Country Position/Affiliation
Antwerp 2000 Belgium Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results will be shared once Clinical Study Report will be available Study Protocol within 12 months of Clinical Study report finalization open access
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