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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 : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Collaborators:
Fann Hospital, Senegal
Ministry of Health, Senegal
Diamniadio Children Hospital, Senegal
Dalal Jamm Hospital, Senegal
Epicentre, Paris, France.
Information provided by (Responsible Party):
Institut Pasteur de Dakar

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).

Two therapeutic regimens have been eligible in the short term for SEN-CoV-Fadj: Hydroxychloroquine (HCQ) on one hand, and the combination of Hydroxychloroquine and Azithromycin (HCQ + AZM) on the other hand.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Hydroxychloroquine + Azithromycin Phase 3

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).

Two therapeutic regimens have been retained in the short term for SEN-CoV-Fadj: Hydroxychloroquine (HCQ) on one hand, and the combination of Hydroxychloroquine and Azithromycin (HCQ + AZM) on the other hand.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre, Open Label, Randomised, Adaptative Clinical Trial of Efficacy and Safety of Treatment Regimens in Adult COVID-19 Patients in Senegal
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2021


Arm Intervention/treatment
Active Comparator: Hydroxychloroquine (HCQ) Drug: Hydroxychloroquine

800 mg in two doses at Day 1, then 200 mg per os twice a day from Day 2 to Day 10.

If creatinine clearance becomes inferior to 50 mL/min, the posology will be reduced to 200 mg per day.


Experimental: Hydroxychloroquine + Azithromycin (HCQ + AZM) Drug: Hydroxychloroquine + Azithromycin

Hydroxychloroquine 800 mg in two doses at Day 1, then 200 mg per os twice a day from Day 2 to Day 10, and Azithromycin 500 mg at Day 1, then 250 mg each day from Day 2 to Day 5 included.

If creatinine clearance becomes inferior to 50 mL/min, the Hydroxychloroquine posology will be reduced to 200 mg per day.





Primary Outcome Measures :
  1. SARS-CoV-2 viral load level [ Time Frame: Day 7 ]
    Real time-PCR (RT-PCR) result of the naso- and oro-pharyngeal sample


Secondary Outcome Measures :
  1. Vital status [ Time Frame: Day 15 ]
  2. Proportion of patients with serious adverse events reported during the clinical trial. [ Time Frame: through study completion, an average of 7 months ]
  3. Length of hospitalization [ Time Frame: through hospitalization, an average of 2 weeks ]
  4. Length of hospitalization in a resuscitation unit [ Time Frame: through hospitalization, an average of 2 weeks ]
  5. Duration of oxygen therapy [ Time Frame: through hospitalization, an average of 2 weeks ]
  6. Maximum quick SOFA (qSOFA) score during hospitalisation [ Time Frame: through hospitalization, an average of 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 if not married, ≥15 years if married woman, ≥16 years if married man)
  • Full understanding and consent to participate to the trial
  • No counter-indications to taking the tested treatments

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390594


Contacts
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Contact: Fabien Taieb, MD, PhD 00221770979235 Fabien.taieb@pasteur.sn
Contact: Moussa Seydi, MD 002218691881 seydim@u.washington.edu

Locations
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Senegal
Infectious and Tropical Diseases Department, Fann Hospital
Dakar, Senegal
Contact: Moussa Seydi, MD    002218691881    seydim@u.washington.edu   
Contact: Aissatou Lakhe, MD    00221775417301    aissatoulakhe@gmail.com   
Sub-Investigator: Khardiata D. Mbaye, MD         
Sub-Investigator: Aissatou Lakhe, MD         
Sub-Investigator: Pape S. Ba, MD         
Sub-Investigator: Louise Fortes, MD         
Sub-Investigator: Maguette N. Fall, MD         
Sub-Investigator: Oumar Kane, MD         
Diamniadio Children Hospital
Diamniadio, Senegal
Contact: Maguette N. Fall, MD    00221777098736    maguifall4@gmail.com   
Contact: Aissatou Lakhe, MD    00221775417301    aissatoulakhe@gmail.com   
Sub-Investigator: Maguette N. Fall, MD         
Sub-Investigator: Aissatou Lakhe, MD         
Sub-Investigator: Pape S. Ba, MD         
Dalal Jamm Hospital
Guédiawaye, Senegal
Contact: Louise Fortes, MD    00221775595333    louisefortes@yahoo.fr   
Contact: Fatou SD Ndiaye, MD       kinepierre1@gmail.com   
Sub-Investigator: Louise Fortes, MD         
Sub-Investigator: Fatou SD Ndiaye, MD         
Sub-Investigator: Abdoul Kane, MD         
Sub-Investigator: Aissatou Lakhe, MD         
Sub-Investigator: Pape S. Ba, MD         
Sponsors and Collaborators
Institut Pasteur de Dakar
Fann Hospital, Senegal
Ministry of Health, Senegal
Diamniadio Children Hospital, Senegal
Dalal Jamm Hospital, Senegal
Epicentre, Paris, France.
Investigators
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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

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Responsible Party: Institut Pasteur de Dakar
ClinicalTrials.gov Identifier: NCT04390594    
Other Study ID Numbers: 2020-002
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Pasteur de Dakar:
COVID-19
SARS-CoV-2
Efficacy
Safety
Senegal
Hydroxychloroquine
Azithromycin
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents