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

NCT ID: NCT04390594

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-13
• Study Completion Date: 2023-02-08

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

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Nafamostat Mesilate

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fann Hospital, Senegal

UNKNOWN

Sponsor Role: collaborator

Ministry of Health, Senegal

OTHER_GOV

Sponsor Role: collaborator

Diamniadio Children Hospital, Senegal

UNKNOWN

Sponsor Role: collaborator

Dalal Jamm Hospital, Senegal

OTHER

Sponsor Role: collaborator

Institut Pasteur Korea

UNKNOWN

Sponsor Role: collaborator

Institut Pasteur de Dakar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moussa Seydi, MD

Role: PRINCIPAL_INVESTIGATOR

Fann Hospital, Senegal

Amadou A. Sall, PhD

Role: STUDY_DIRECTOR

Institut Pasteur de Dakar, Senegal

Fabien Taieb, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Dakar, Senegal

Locations

Infectious and Tropical Diseases Department, Fann Hospital

Dakar, , Senegal

Diamniadio Children Hospital

Diamniadio, , Senegal

Dalal Jamm Hospital

Guédiawaye, , Senegal

Countries

Senegal

Other Identifiers

2020-002

Identifier Type: -

Identifier Source: org_study_id