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

NCT04390594 | Terminated Phase 3 DMC

• 1 other identifier: 2020-002
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 viral load level

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

  Day 7

Secondary Outcomes (7)

• Vital status

  Day 15

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

  through study completion, an average of 7 months

• Length of hospitalization

  through hospitalization, an average of 2 weeks

• Length of hospitalization in a resuscitation unit

  through hospitalization, an average of 2 weeks

• Duration of oxygen therapy

  through hospitalization, an average of 2 weeks

Study Arms (2)

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

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

Standard of Care + Nafamostat mesilate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Pregnant or breastfeeding woman
• 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

Sponsors & Collaborators

• Institut Pasteur de Dakar: lead
• Fann Hospital, Senegal: collaborator
• Ministry of Health, Senegal: collaborator
• Diamniadio Children Hospital, Senegal: collaborator
• Dalal Jamm Hospital, Senegal: collaborator
• Institut Pasteur Korea: collaborator

Study Sites (3)

Infectious and Tropical Diseases Department, Fann Hospital

Dakar, Senegal

Location

Diamniadio Children Hospital

Diamniadio, Senegal

Location

Dalal Jamm Hospital

Guédiawaye, Senegal

Location

MeSH Terms

Conditions

COVID-19

Interventions

nafamostat

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 15, 2020
• Study Start: August 13, 2020
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: June 21, 2024

Record last verified: 2020-09

Locations

SE (3)