Efficacy and Safety Evaluation of Treatment Regimens in A... | NCT04390594

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

NCT04390594

Sponsor

Institut Pasteur de Dakar

Status

Terminated

Last Update Posted

Jun 21, 2024Actual

Enrollment

59Actual

Phase

Phase 3

Conditions

COVID-19

Interventions

Nafamostat Mesilate

Countries

Senegal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

In conclusion, the results of the SEN-CoV Fadj trial to date do not meet the objectives of the clinical trial and the sample size required to meet them is clearly too large to be achieved within a reasonable time.

Expanded Access Info

Start Date

Aug 13, 2020Actual

Primary Completion Date

Feb 8, 2023Actual

Completion Date

Feb 8, 2023Actual

First Submitted Date

May 14, 2020

First Submission Date that Met QC Criteria

May 14, 2020

First Posted Date

May 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2024

Last Update Posted Date

Jun 21, 2024Actual

Name	Class
Fann Hospital, Senegal	UNKNOWN
Ministry of Health, Senegal	OTHER_GOV
Diamniadio Children Hospital, Senegal	UNKNOWN
Dalal Jamm Hospital, Senegal

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care	No Intervention	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.
Standard of Care + Nafamostat mesilate	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nafamostat Mesilate	Drug	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

Measure	Description	Time Frame
SARS-CoV-2 viral load level	Real time-PCR (RT-PCR) result of the naso- and oro-pharyngeal sample	Day 7

Measure	Description	Time Frame
Vital status		Day 15
Proportion of patients with serious adverse events reported during the clinical trial.		through study completion, an average of 7 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Moussa Seydi, MD	Fann Hospital, Senegal	Principal Investigator
Amadou A. Sall, PhD	Institut Pasteur de Dakar, Senegal	Study Director
Fabien Taieb, MD, PhD	Institut Pasteur de Dakar, Senegal	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Infectious and Tropical Diseases Department, Fann Hospital		Dakar			Senegal
Diamniadio Children Hospital

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections