Aim: To establish a clinical research network that can design and rapidly implement ICH-compliant, high quality, large-scale, multi-site clinical studies in preparation for and response to outbreaks in Sub Saharan Africa (SSA).
Efforts are continuing to recruit and record more participants for the study. Here is the update by country:
FISSA recruitment is underway in 14/16 sites (Fann and Moramanga yet to start), 5,816 patients have been recruited to date. The total recruitment target for FISSA is 10,000.
Monitoring activities have been affected by Covid-19 and remote monitoring has been performed at some sites. On site monitoring has been performed in Gambia, Ghana and Guinea. Visits to Central and East Africa are planned.
ALERRT is conducting a Covid-19 Clinical Characterisation Protocol (CCP) study with funding received from the Wellcome Trust. The Nested Study is a sub study within the CCP. The study will investigate risk factors and outcomes for Covid with a particular focus on co-morbidities in an African context (anaemia, helminth infections, malaria, HIV, TB and hepatitis). The study will be conducted by ALERRT partners who are already conducting the CCP (Cameroon, Ghana, Senegal, Uganda, DRC and Guinea)
The 7 outstanding countries that had not yet received the approval of their Ethics Committee to begin the study have now obtained it.
Twelve other sites have begun recruiting after the first one started in December 2019.
Due to the necessary restrictions related to the COVID-19 pandemic it was decided that study monitoring would be conducted remotely. Each regional coordination team has therefore monitored the sites belonging to it.
Meetings to support the implementation of the FISSA study have been set up and are hosted on a regular basis; including: Three types of meetings were held on a regular basis
FISSA has so far enrolled 4,426 subjects from 13 clinical sites!
Work is ongoing to establish prospective data and sample collection with a focus on the interaction of COVID-19 with common comorbidities in Africa such as anaemia, malaria, malnutrition, intestinal helminthiasis. This prospective data collection protocol will be submitted as the nested study protocol in next year’s technical report.
The CCP study has so far captured information on around 2500 COVID-19 cases in Africa.
In response to the COVID-19 pandemic, the nested study has been rapidly adapted to focus on this regional health issue. In collaboration with WP4, the COVID-19 clinical characterisation protocol (CCP) has been set up (for more details of the study see our CCP area). The protocol has been adapted to African needs and realities. It has been implemented since April 2020 in 4 countries (Ghana, Senegal, Cameroon and Uganda) and planning is underway to extend to other countries such as Guinea, Central African Republic and Democratic Republic of Congo.
The first step of this CCPis essentially the implementation of ‘Tier 0’ which consists of the collection of clinical data only.
FISSA has now recruited 2,845 participants from 13 sites!
ALERRT's Fever in Subsaharan Africa (FISSA) study has now been registered on the ISRCTN clinical trials registry.
The FISSA study is expected to open to recruitment on the 16th of December.
Anani Badje and Robert Akpata from PAC-CI have been working hard to get all of the FISSA sites trained and ready to start. See below for photos of training sessions held at CHR d'Ayamé, Côte d'Ivoire; St. Francis Xavier Hospital, Ghana; CHU de Treichville, Côte d'Ivoire; Clinical Service Department of Fajara, Gambia; Children's Hospital of Diamniadio, Senegal and CHU de Fann, Senegal.
The site selection process for clinical sites participating in the ALERRT Core Study began in August 2018. A selection procedure was written and assessment forms were developed for clinical sites and partners. Out of a total of 27 sites proposed 16 were selected, including 8 in West Africa, 4 in Central Africa and 4 in East Africa. This list was endorsed by the ALERRT Executive Committee at a meeting held on March 19th in Dakar, Senegal. Visit the about us section for a comprehensive list and map of the sites operating across ALERRT.