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NCT04390594

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

  1. Study Type
  2. Interventional
  1. Study Aim
  2. Treatment and Management
  1. Study Design
  2. Parallel/Crossover
  1. Intervention Assignment
  2. Randomised
  1. Population (8)
  2. Male and Female
  3. COVID-19
  4. Adult
  5. Aged (65+)
  6. Child
  1. Intervention (2)
  2. Azithromycin
  3. Hydroxychloroquine
  1. Comparison (1)
  2. Hydroxychloroquine
  1. Outcome (6)
  2. Serious Adverse Event
  3. Hospitalization
  4. SARS-CoV-2 Virus
  5. Viral load
  6. Oxygen Therapy
  7. Sequential Organ Failure Assessment Score

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

Institut Pasteur de Dakar
First Published (first received 2020 May 15)ClinicalTrials.gov (https://clinicaltrials.gov/show/NCT04390594)
Trial registry record
No Results
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