NCT04390594: SEN-CoV-Fadj

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

Terminated Phase 3 Last updated 21 June 2024

What this trial tests

Phase 3 trial testing Nafamostat Mesilate in COVID-19 in 59 participants. Terminated before completion.

Timeline

13 August 2020

Primary endpoint
8 February 2023

8 February 2023

Quick facts

Lead sponsor	Institut Pasteur de Dakar
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	13 August 2020
Primary completion	8 February 2023
Estimated completion	8 February 2023
Sites	3 locations across Senegal

Drugs / interventions tested

• Nafamostat Mesilate — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Institut Pasteur de Dakar

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
2. Targeting transcriptional regulation of SARS-CoV-2 entry factors <i>ACE2</i> and <i>TMPRSS2</i>.
   Qiao Y, Wang XM, Mannan R, Pitchiaya S, et al · · 2021 · cited 155× · PMID 33310900 · DOI 10.1073/pnas.2021450118
3. The TMPRSS2 Inhibitor Nafamostat Reduces SARS-CoV-2 Pulmonary Infection in Mouse Models of COVID-19.
   Li K, Meyerholz DK, Bartlett JA, McCray PB. · · 2021 · cited 113× · PMID 34340553 · DOI 10.1128/mbio.00970-21
4. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
   Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
5. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
   Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
6. Antibiotics for the treatment of COVID-19.
   Popp M, Stegemann M, Riemer M, Metzendorf MI, et al · · 2021 · cited 60× · PMID 34679203 · DOI 10.1002/14651858.cd015025
7. The Transmembrane Protease TMPRSS2 as a Therapeutic Target for COVID-19 Treatment.
   Wettstein L, Kirchhoff F, Münch J. · · 2022 · cited 55× · PMID 35163273 · DOI 10.3390/ijms23031351
8. The intersection of COVID-19 and cancer: signaling pathways and treatment implications.
   Zong Z, Wei Y, Ren J, Zhang L, et al · · 2021 · cited 54× · PMID 34001144 · DOI 10.1186/s12943-021-01363-1