COVID-19Phase 3SEN-CoV-FadjNCT04390594

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

A Phase 3 study testing Nafamostat Mesilate in people with COVID-19, run by Institut Pasteur de Dakar at 3 sites in Senegal.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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%. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Nafamostat Mesilate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 3 sitesSenegal
Study dates: 13 Aug 2020to 8 Feb 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 23Show fewer

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

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

Senegal3 sites

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

Other trials in Senegal

About this study

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

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.

Read the 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

Conditions: COVID-19
Being tested: Nafamostat Mesilate
Keywords: COVID-19, SARS-CoV-2, Efficacy, Safety, Senegal, Nafamostat mesilate
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nafamostat MesilateDrug
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

Study groups in NCT04390594
Study group	Role	What they receive
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 Receives: Drug: Nafamostat Mesilate

What is being measured

The primary outcome is the main question the study is designed to answer.

SARS-CoV-2 viral load level
Real time-PCR (RT-PCR) result of the naso- and oro-pharyngeal sample
Measured: Day 7

Secondary outcomes (7)

Vital status
Measured: Day 15
Proportion of patients with serious adverse events reported during the clinical trial.
Measured: through study completion, an average of 7 months
Length of hospitalization
Measured: through hospitalization, an average of 2 weeks
Length of hospitalization in a resuscitation unit
Measured: through hospitalization, an average of 2 weeks
Duration of oxygen therapy
Measured: through hospitalization, an average of 2 weeks
Maximum quick SOFA (qSOFA) score during hospitalisation
Measured: through hospitalization, an average of 2 weeks
Clinical status on the seven-category ordinal scale
1. not hospitalized with resumption of normal activities;
2. not hospitalized, but unable to resume normal activities;
3. hospitalization, not requiring supplemental oxygen;
4. hospitalization, requiring supplemental oxygen;
5. hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation;
6. hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation;
7. death.
Measured: through hospitalization, an average of 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 20208 Feb 2023

First posted15 May 2020
Study start13 Aug 2020
Primary completion8 Feb 2023
Study completion8 Feb 2023

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04390594
Sponsor's protocol ID: 2020-002
Acronym: SEN-CoV-Fadj
Status last verified: Sep 2020
First submitted: 14 May 2020
Last updated: 21 Jun 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicentre, Open Label, Randomised, Adaptative Clinical Trial of Efficacy and Safety of Treatment Regimens in Adult COVID-19 Patients in Senegal
ClinicalTrials.gov ID: NCT04390594
Acronym / sponsor ID: SEN-CoV-Fadj / 2020-002
Conditions: COVID-19
Keywords: COVID-19, SARS-CoV-2, Efficacy, Safety, Senegal, Nafamostat mesilate
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason 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.
Enrolment: 59 participants (actual)
Lead sponsor: Institut Pasteur de DakarUniversity, hospital or other
Collaborators: Fann Hospital, Senegal, Ministry of Health, Senegal, Diamniadio Children Hospital, Senegal, Dalal Jamm Hospital, Senegal, Institut Pasteur Korea
Study start: 13 Aug 2020 (actual)
Primary completion: 8 Feb 2023 (actual)
Study completion: 8 Feb 2023 (actual)
First posted: 15 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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	Drug: 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nafamostat MesilateNafamostat 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	Drug	Standard of Care + Nafamostat mesilate

Primary outcome

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

7 secondary outcomes

Vital status
Time frame: Day 15
Proportion of patients with serious adverse events reported during the clinical trial.
Time frame: through study completion, an average of 7 months
Length of hospitalization
Time frame: through hospitalization, an average of 2 weeks
Length of hospitalization in a resuscitation unit
Time frame: through hospitalization, an average of 2 weeks
Duration of oxygen therapy
Time frame: through hospitalization, an average of 2 weeks
Maximum quick SOFA (qSOFA) score during hospitalisation
Time frame: through hospitalization, an average of 2 weeks
Clinical status on the seven-category ordinal scale
Time frame: through hospitalization, an average of 2 weeks

Results and safety

The study was stopped early (reason given: 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.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Moussa Seydi, MD principal investigator

Fann Hospital, Senegal

Amadou A. Sall, PhD study director

Institut Pasteur de Dakar, Senegal

Fabien Taieb, MD, PhD principal investigator

Institut Pasteur de Dakar, Senegal

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nafamostat Mesilate in people with COVID-19, run by Institut Pasteur de Dakar at 3 sites in Senegal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARS-CoV-2 viral load level (time frame: Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04390594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.