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

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.

Conditions

• COVID-19

Interventions

DRUG

Nafamostat Mesilate

Nafamostat mesilate continuous intravenous injection. Daily dose ranging between 0.1 mg/kg/h and 0.2 mg/kg/h, based on the severity and underlying disease of the clinical trial participant. Administration for 10-14 days based on the severity and underlying disease of the clinical trial participant

Sponsors & Collaborators

• Fann Hospital, Senegal

  collaborator UNKNOWN

• Ministry of Health, Senegal

  collaborator OTHER_GOV

• Diamniadio Children Hospital, Senegal

  collaborator UNKNOWN

• Dalal Jamm Hospital, Senegal

  collaborator OTHER

• Institut Pasteur Korea

  collaborator UNKNOWN

• Institut Pasteur de Dakar

  lead OTHER

Principal Investigators

• Moussa Seydi, MD · Fann Hospital, Senegal

• Amadou A. Sall, PhD · Institut Pasteur de Dakar, Senegal

• Fabien Taieb, MD, PhD · Institut Pasteur de Dakar, Senegal

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-13

Primary Completion

2023-02-08

Completion

2023-02-08

Countries

• Senegal

Study Locations