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).

 

December 2022

FISSA Study

Currently analysis is ongoing. The team has started working on the paper with the introduction and methodology but pending final result to complete the paper.

Nested Study

  • 5 countries involved instead of 6: Cameroon, Ghana, Guinea, Sénégal, Uganda. DRC team will no longer participate.

  • Cameroon has already completed the training and can start enrolling.

  • Uganda is almost ready to start.

  • Guinea: training to take place next week. They currently have 42 COVID patients.

  • Ghana and Sénégal to submit to ethics committee. Ghana almost ready to start.

CCP Update

Efforts are continuing to recruit and record more participants for the study. A total of 11,909 cases and 745 deaths have been collected. Cameroon recorded data prospectively while others collected both retro and prospectively. Here is the update by country recorded so far: 

  • Uganda: 3466 cases and 414 deaths.

  • Guinea: 4012 cases and 231 deaths.

  • Cameroun: 415 cases and 5 deaths.

  • DRC: 229 cases and 11 deaths.

  • Ghana: 3787 cases and 84 deaths.

November 2021

CCP Update

Efforts are continuing to recruit and record more participants for the study. Here is the update by country: 

  • Uganda: no report of active case of COVID-19. Still retrospective data from 1,543 COVID-19 patients have been recorded into the REDCap. The team has completed training for one new site making it 3 sites contributing to the retrospective data collection;
  • Guinea: retrospectively data from 603 COVID-19 patients have been recorded into the REDCap.
  • Cameroun: team have stopped data collection. Follow-up for month six is over and that of month nine has started this week. There were 157 patients with month 6 follow-up. From which 34 came back positive with 18 contamination and 40% being due to malaria. To date, 58 patients have withdrawn from the study.
  • Senegal: no new update. Still at 1,497 COVID-19 cases have been retrospectively recorded and no new cases.

April 2021

FISSA Study

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.

Nested Study

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)

January 2021

Febrile Illness in Sub-Saharan Africa (FISSA) Study

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

  • The monthly Steering Committee meetings which gather all WPs and other ALERRT partners
  • The monthly meetings of the International Coordination, which brings together the International Coordination and the 3 regional coordinators
  • Bimonthly Regional Meetings between each of the Regional Coordinators and the sites belonging to these regions

FISSA has so far enrolled 4,426 subjects from 13 clinical sites!

Nested Study

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.

May 2020

Nested Study

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.

November 2020

FISSA has now recruited 2,845 participants from 13 sites!

 

December 2019

FISSA study to open soon!

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.

November 2019

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.

          
 

May 2019

Site selection for Core Study

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.