Back to results

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

Primary Purpose

COVID-19

Status

Unknown status

Phase

Phase 3

Locations

Senegal

Study Type

Interventional

Intervention

Nafamostat Mesilate

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, Efficacy, Safety, Senegal, Nafamostat mesilate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Infectious and Tropical Diseases Department, Fann HospitalRecruiting
Diamniadio Children Hospital
Dalal Jamm Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Standard of Care + Nafamostat mesilate

Arm Description

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.

Outcomes

Primary Outcome Measures

SARS-CoV-2 viral load level

Real time-PCR (RT-PCR) result of the naso- and oro-pharyngeal sample

Secondary Outcome Measures

Vital status

Proportion of patients with serious adverse events reported during the clinical trial.

Length of hospitalization

Length of hospitalization in a resuscitation unit

Duration of oxygen therapy

Maximum quick SOFA (qSOFA) score during hospitalisation

Clinical status on the seven-category ordinal scale

not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalization, not requiring supplemental oxygen; hospitalization, requiring supplemental oxygen; hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; death.

Full Information

NCT ID

NCT04390594

First Posted

May 14, 2020

Last Updated

September 3, 2020

Sponsor

Institut Pasteur de Dakar

Collaborators

Fann Hospital, Senegal, Ministry of Health, Senegal, Diamniadio Children Hospital, Senegal, Dalal Jamm Hospital, Senegal, Institut Pasteur Korea

1. Study Identification

Unique Protocol Identification Number

NCT04390594

Brief Title

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

Acronym

SEN-CoV-Fadj

Official Title

Multicentre, Open Label, Randomised, Adaptative Clinical Trial of Efficacy and Safety of Treatment Regimens in Adult COVID-19 Patients in Senegal

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 13, 2020 (Actual)

Primary Completion Date

February 12, 2021 (Anticipated)

Study Completion Date

August 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Pasteur de Dakar

Collaborators

Fann Hospital, Senegal, Ministry of Health, Senegal, Diamniadio Children Hospital, Senegal, Dalal Jamm Hospital, Senegal, Institut Pasteur Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

COVID-19, SARS-CoV-2, Efficacy, Safety, Senegal, Nafamostat mesilate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Arm Title

Standard of Care + Nafamostat mesilate

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nafamostat Mesilate

Intervention Description

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 Measure Information:

Title

SARS-CoV-2 viral load level

Description

Real time-PCR (RT-PCR) result of the naso- and oro-pharyngeal sample

Time Frame

Day 7

Secondary Outcome Measure Information:

Title

Vital status

Time Frame

Day 15

Title

Proportion of patients with serious adverse events reported during the clinical trial.

Time Frame

through study completion, an average of 7 months

Title

Length of hospitalization

Time Frame

through hospitalization, an average of 2 weeks

Title

Length of hospitalization in a resuscitation unit

Time Frame

through hospitalization, an average of 2 weeks

Title

Duration of oxygen therapy

Time Frame

through hospitalization, an average of 2 weeks

Title

Maximum quick SOFA (qSOFA) score during hospitalisation

Time Frame

through hospitalization, an average of 2 weeks

Title

Clinical status on the seven-category ordinal scale

Description

Time Frame

through hospitalization, an average of 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fabien Taieb, MD, PhD

Phone

00221770979235

Fabien.taieb@pasteur.sn

First Name & Middle Initial & Last Name or Official Title & Degree

Moussa Seydi, MD

Phone

002218691881

seydim@u.washington.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moussa Seydi, MD

Organizational Affiliation

Fann Hospital, Senegal

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Amadou A. Sall, PhD

Organizational Affiliation

Institut Pasteur de Dakar, Senegal

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Fabien Taieb, MD, PhD

Organizational Affiliation

Institut Pasteur de Dakar, Senegal

Official's Role

Principal Investigator

Facility Information:

Facility Name

Infectious and Tropical Diseases Department, Fann Hospital

City

Dakar

Country

Senegal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moussa Seydi, MD

Phone

002218691881

seydim@u.washington.edu

First Name & Middle Initial & Last Name & Degree

Aissatou Lakhe, MD

Phone

00221775417301

aissatoulakhe@gmail.com

First Name & Middle Initial & Last Name & Degree

Khardiata D. Mbaye, MD

First Name & Middle Initial & Last Name & Degree

Aissatou Lakhe, MD

First Name & Middle Initial & Last Name & Degree

Pape S. Ba, MD

First Name & Middle Initial & Last Name & Degree

Louise Fortes, MD

First Name & Middle Initial & Last Name & Degree

Maguette N. Fall, MD

First Name & Middle Initial & Last Name & Degree

Oumar Kane, MD

First Name & Middle Initial & Last Name & Degree

Papa M. Gueye, Pharmacist

Facility Name

Diamniadio Children Hospital

City

Diamniadio

Country

Senegal

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maguette N. Fall, MD

Phone

00221777098736

maguifall4@gmail.com

First Name & Middle Initial & Last Name & Degree

Aissatou Lakhe, MD

Phone

00221775417301

aissatoulakhe@gmail.com

First Name & Middle Initial & Last Name & Degree

Maguette N. Fall, MD

First Name & Middle Initial & Last Name & Degree

Aissatou Lakhe, MD

First Name & Middle Initial & Last Name & Degree

Pape S. Ba, MD

Facility Name

Dalal Jamm Hospital

City

Guédiawaye

Country

Senegal

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Louise Fortes, MD

Phone

00221775595333

louisefortes@yahoo.fr

First Name & Middle Initial & Last Name & Degree

Fatou SD Ndiaye, MD

kinepierre1@gmail.com

First Name & Middle Initial & Last Name & Degree

Louise Fortes, MD

First Name & Middle Initial & Last Name & Degree

Fatou SD Ndiaye, MD

First Name & Middle Initial & Last Name & Degree

Abdoul Kane, MD

First Name & Middle Initial & Last Name & Degree

Aissatou Lakhe, MD

First Name & Middle Initial & Last Name & Degree

Pape S. Ba, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs