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Trial record 8 of 12 for:    Nafamostat

Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal (SEN-CoV-Fadj)

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ClinicalTrials.gov Identifier: NCT04390594
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : September 7, 2020
Sponsor:
Collaborators:
Fann Hospital, Senegal
Ministry of Health, Senegal
Diamniadio Children Hospital, Senegal
Dalal Jamm Hospital, Senegal
Institut Pasteur Korea
Information provided by (Responsible Party):
Institut Pasteur de Dakar

Brief 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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Nafamostat Mesilate Phase 3

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre, Open Label, Randomised, Adaptative Clinical Trial of Efficacy and Safety of Treatment Regimens in Adult COVID-19 Patients in Senegal
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : February 12, 2021
Estimated Study Completion Date : August 12, 2021

Arm Intervention/treatment
No Intervention: Standard of Care
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.
Experimental: Standard of Care + Nafamostat mesilate
  • 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





Primary Outcome Measures :
  1. SARS-CoV-2 viral load level [ Time Frame: Day 7 ]
    Real time-PCR (RT-PCR) result of the naso- and oro-pharyngeal sample


Secondary Outcome Measures :
  1. Vital status [ Time Frame: Day 15 ]
  2. Proportion of patients with serious adverse events reported during the clinical trial. [ Time Frame: through study completion, an average of 7 months ]
  3. Length of hospitalization [ Time Frame: through hospitalization, an average of 2 weeks ]
  4. Length of hospitalization in a resuscitation unit [ Time Frame: through hospitalization, an average of 2 weeks ]
  5. Duration of oxygen therapy [ Time Frame: through hospitalization, an average of 2 weeks ]
  6. Maximum quick SOFA (qSOFA) score during hospitalisation [ Time Frame: through hospitalization, an average of 2 weeks ]
  7. Clinical status on the seven-category ordinal scale [ Time Frame: through hospitalization, an average of 2 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed cases of SARS-CoV-2 infection hospitalized in reference services identified by the Ministry of Health and Social Action of Senegal
  • Adults (≥18 years)
  • Full understanding and consent to participate to the trial
  • No contraindications to taking the tested treatments
  • Clinical status from 3 to 5 on the seven-category ordinal scale
  • Pneumonia highlighted by infiltration of the lungs by chest CT scan or chest radiography
  • Absence of contraindications to radiographic examinations (X-ray and/or CT scan) for diagnosis and/or follow-up
  • Inclusion in the 72 hours following the radiological pneumonia confirmation

Non-inclusion Criteria:

  • Pregnant or breastfeeding woman
  • Patient at high risk of death within 3 days of inclusion, in the clinician's opinion
  • Corrected QT interval (QTc) >500ms
  • Heart electrical dysfunction: atrioventricular block Mobitz type II second-degree, high-grade or complete without a functioning pacemaker
  • Uncontrolled and clinically significant heart diseases, such as arrhythmia, angina or decompensated congestive heart failure
  • Kidney failure (Cl < 30 mL/min)
  • Patients with liver cirrhosis whose Child-Puch score is B or C
  • Patients who have liver disease abnormalities with ALT or AST > 5 times ULN
  • Patients who have a known HIV status
  • Patients who have other clinically-important diseases in decompensation which may interfere with the evaluation or completion of the tested treatment's procedure, in the clinician's opinion
  • Patients with a clinical or psychological condition which, in the clinician's opinion, does not allow adequate evaluation of the tested treatment
  • Known allergy to the studied treatment regimen
  • Other contraindications with the studied treatment regimen
  • Known drug-drug interaction with a treatment usually taken by the participant contraindicating one of the studied treatment regimen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390594


Contacts
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Contact: Fabien Taieb, MD, PhD 00221770979235 Fabien.taieb@pasteur.sn
Contact: Moussa Seydi, MD 002218691881 seydim@u.washington.edu

Locations
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Senegal
Infectious and Tropical Diseases Department, Fann Hospital Recruiting
Dakar, Senegal
Contact: Moussa Seydi, MD    002218691881    seydim@u.washington.edu   
Contact: Aissatou Lakhe, MD    00221775417301    aissatoulakhe@gmail.com   
Sub-Investigator: Khardiata D. Mbaye, MD         
Sub-Investigator: Aissatou Lakhe, MD         
Sub-Investigator: Pape S. Ba, MD         
Sub-Investigator: Louise Fortes, MD         
Sub-Investigator: Maguette N. Fall, MD         
Sub-Investigator: Oumar Kane, MD         
Sub-Investigator: Papa M. Gueye, Pharmacist         
Diamniadio Children Hospital Not yet recruiting
Diamniadio, Senegal
Contact: Maguette N. Fall, MD    00221777098736    maguifall4@gmail.com   
Contact: Aissatou Lakhe, MD    00221775417301    aissatoulakhe@gmail.com   
Sub-Investigator: Maguette N. Fall, MD         
Sub-Investigator: Aissatou Lakhe, MD         
Sub-Investigator: Pape S. Ba, MD         
Dalal Jamm Hospital Not yet recruiting
Guédiawaye, Senegal
Contact: Louise Fortes, MD    00221775595333    louisefortes@yahoo.fr   
Contact: Fatou SD Ndiaye, MD       kinepierre1@gmail.com   
Sub-Investigator: Louise Fortes, MD         
Sub-Investigator: Fatou SD Ndiaye, MD         
Sub-Investigator: Abdoul Kane, MD         
Sub-Investigator: Aissatou Lakhe, MD         
Sub-Investigator: Pape S. Ba, MD         
Sponsors and Collaborators
Institut Pasteur de Dakar
Fann Hospital, Senegal
Ministry of Health, Senegal
Diamniadio Children Hospital, Senegal
Dalal Jamm Hospital, Senegal
Institut Pasteur Korea
Investigators
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Principal Investigator: Moussa Seydi, MD Fann Hospital, Senegal
Study Director: Amadou A. Sall, PhD Institut Pasteur de Dakar, Senegal
Principal Investigator: Fabien Taieb, MD, PhD Institut Pasteur de Dakar, Senegal
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Responsible Party: Institut Pasteur de Dakar
ClinicalTrials.gov Identifier: NCT04390594    
Other Study ID Numbers: 2020-002
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Pasteur de Dakar:
COVID-19
SARS-CoV-2
Efficacy
Safety
Senegal
Nafamostat mesilate
Additional relevant MeSH terms:
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Nafamostat
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anticoagulants
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors