drugset / Trial / NCT04390594

Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal

NCT04390594

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-08-13
Primary completion
2023-02-08
Completion
2023-02-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Nafamostat Small molecule 0.1 mg/kg Intravenous
Subject Nafamostat Small molecule 0.2 mg/kg Intravenous

Indications