A Phase 3 interventional study of Nafamostat Mesilate in COVID-19, sponsored by Institut Pasteur de Dakar. Terminated at 3 sites in Senegal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Institut Pasteur de Dakar · Phase 3, Interventional, and Treatment
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:
Inclusion Criteria:
Non-inclusion Criteria:
The Standard of Care is the treatment which is the most adapted to the patient in the clinician's opinion. It could include the combination of Hydroxychloroquine and Azithromycin in the absence of contraindication.
* The Standard of Care is the treatment which is the most adapted to the patient in the clinician's opinion. It could include the combination of Hydroxychloroquine and Azithromycin in the absence of contraindication. * Nafamostat mesilate
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
SARS-CoV-2 viral load level
Real time-PCR (RT-PCR) result of the naso- and oro-pharyngeal sample
Time frame: Day 7
Vital status
Time frame: Day 15
Proportion of patients with serious adverse events reported during the clinical trial.
Time frame: through study completion, an average of 7 months
Length of hospitalization
Time frame: through hospitalization, an average of 2 weeks
Length of hospitalization in a resuscitation unit
Time frame: through hospitalization, an average of 2 weeks
Duration of oxygen therapy
Time frame: through hospitalization, an average of 2 weeks
Maximum quick SOFA (qSOFA) score during hospitalisation
Time frame: through hospitalization, an average of 2 weeks
Clinical status on the seven-category ordinal scale
1. not hospitalized with resumption of normal activities; 2. not hospitalized, but unable to resume normal activities; 3. hospitalization, not requiring supplemental oxygen; 4. hospitalization, requiring supplemental oxygen; 5. hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6. hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 7. death.
Time frame: through hospitalization, an average of 2 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Institut Pasteur de Dakar