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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

Tracking Information
First Submitted Date  ICMJE May 14, 2020
First Posted Date  ICMJE May 15, 2020
Last Update Posted Date September 7, 2020
Actual Study Start Date  ICMJE August 13, 2020
Estimated Primary Completion Date February 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
SARS-CoV-2 viral load level [ Time Frame: Day 7 ]
Real time-PCR (RT-PCR) result of the naso- and oro-pharyngeal sample
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2020)
  • 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 [ 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal
Official Title  ICMJE Multicentre, Open Label, Randomised, Adaptative Clinical Trial of Efficacy and Safety of Treatment Regimens in Adult COVID-19 Patients in Senegal
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.

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE 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

Study Arms  ICMJE
  • 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
    Intervention: Drug: Nafamostat Mesilate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2020)
186
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2020)
258
Estimated Study Completion Date  ICMJE August 12, 2021
Estimated Primary Completion Date February 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fabien Taieb, MD, PhD 00221770979235 Fabien.taieb@pasteur.sn
Contact: Moussa Seydi, MD 002218691881 seydim@u.washington.edu
Listed Location Countries  ICMJE Senegal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04390594
Other Study ID Numbers  ICMJE 2020-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Institut Pasteur de Dakar
Study Sponsor  ICMJE Institut Pasteur de Dakar
Collaborators  ICMJE
  • Fann Hospital, Senegal
  • Ministry of Health, Senegal
  • Diamniadio Children Hospital, Senegal
  • Dalal Jamm Hospital, Senegal
  • Institut Pasteur Korea
Investigators  ICMJE
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
PRS Account Institut Pasteur de Dakar
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP