COVID-19 Clinical Trial
Official title:
Multicentre, Open Label, Randomised, Adaptative Clinical Trial of Efficacy and Safety of Treatment Regimens in Adult COVID-19 Patients in Senegal
COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused
by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in
December 2019. A rapid spread of the disease has occurred at a global scale, associated with
a mortality rate of 3.4%. The first case in Africa was declared on February 15, 2020 in Egypt
and the first case in Senegal was declared on March 2nd, 2020.
In this context, the SEN-CoV-Fadj clinical trial aims to evaluate efficacy and safety, among
adults, of different therapeutic regimens considered optimal according to current knowledge,
as well as available and adapted to Sub-Saharan Africa. This trial is nested into a cohort of
confirmed cases of COVID-19 in Senegal aiming to understand the main clinical, biological,
virologic and immunological characteristics of the infection. The protocol of the cohort is
based and adapted from the International Severe Acute Respiratory and Emerging Infection
Consortium (ISARIC) / World Health Organization (WHO) Clinical Characterisation Protocol
(CCP).
The Nafamostat mesilate, whose antiviral, anticoagulant an anti-inflammatory activities have
been shown, has been eligible for SEN-CoV-Fadj for the treatment of moderate to severe
COVID-19 cases.
COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused
by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in
December 2019. A rapid spread of the disease has occurred at a global scale, associated with
a mortality rate of 3.4%. The first case in Africa was declared on February 15, 2020 in Egypt
and the first case in Senegal was declared on March 2nd, 2020.
In this context, the SEN-CoV-Fadj clinical trial aims to evaluate efficacy and tolerance,
among adults, of different therapeutic options considered optimal according to current
knowledge, as well as available and adapted to Sub-Saharan Africa. This trial is nested into
a cohort of confirmed cases of COVID-19 in Senegal aiming to understand the main clinical,
biological, virologic and immunological characteristics of the infection. The protocol of the
cohort is based and adapted from the International Severe Acute Respiratory and Emerging
Infection Consortium (ISARIC) / World Health Organization (WHO) Clinical Characterisation
Protocol (CCP).
The Nafamostat mesilate, whose antiviral, anticoagulant an anti-inflammatory activities have
been shown, has been eligible for SEN-CoV-Fadj for the treatment of moderate to severe
COVID-19 cases. Its efficacy and safety will be evaluated against the standard of care used
in Senegal.
The primary objective is to :
Evaluate and compare viral clearance between the different therapeutic interventions.
The secondary objectives are to:
- Evaluate and compare efficacy of the different therapeutic regimens
- Evaluate and compare the tolerance of the different therapeutic regimens
- Evaluate and compare the impact of the different therapeutic interventions on the length
of hospitalization and other clinical measurements
;
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