Clinical Trial of Natural Therapeutics for COVID-19 and Other Acute Respiratory Viral Infections
Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
The trial "Safety, Pharmacokinetics and Preliminary Efficacy of herbal products for the
treatment of acute respiratory viral infections including SARS-CoV2 in Uganda; Phase 2A Open
Label Clinical Trial" is currently being implemented under the Clinical Trials of Natural
therapeutics Program. The trial sample size is 510, and the participants include adults (18
years or more) who fulfill the case definitions of acute respiratory infections (ARI), test
positive for one of the target respiratory viruses, are negative for TB on GeneXpert;
non-pregnant/non-breast-feeding females, have no history of hypersensitivity to any of the
investigational products, and have given written consent to participate in the trial.
The overall objective of the trial is to assess the safety, pharmacokinetics and preliminary
efficacy of TazCoV and Vidicine for the treatment of acute respiratory viral infections
including (SARS-CoV2, RSV and Influenza A/B) in Uganda.
Primary objectives include:
1. To determine the safety and pharmacokinetics of TAZCOV and Vidicine herbal products
among adult participants patients with acute respiratory infections including those due
to laboratory-confirmed SARS-CoV2, RSV and Influenza A/B
2. To determine the extent of SARS-CoV2, RSV, and Influenza A/B viral clearance among adult
participants patients with acute viral respiratory infection treated using TAZCOV and
Vidicine
3. To establish time-to-remission of symptoms among participants patients with acute
respiratory infections including those due to laboratory-confirmed SARS-CoV2, RSV and
Influenza treated with TAZCOV or Vidicine
4. To evaluate disease progression among participants patients with acute respiratory
infections including those due to laboratory-confirmed SARS-CoV2, RSV and Influenza
treated with TAZCOV or Vidicine The end points include: Solicited and unsolicited side
effects (mild, moderate, severe, adverse and serious adverse events), days to viral
clearance (RT-PCR negativity) for those with a positive viral test at enrolment and time
to presenting symptom resolution. The Pharmacokinetic endpoints include: the maximum
concentration of IMP in plasma [Cmax], time taken for the IMP plasma concentration to
reach maximum levels [Tmax] and time taken for the concentration of the IMP in the
plasma or the total amount in the body to be reduced by 50%.
Phase:
Phase 2
Details
Lead Sponsor:
Makerere University
Collaborators:
Directorate of Government Analytical Laboratories Makerere University Biomedical Research Centre Makerere University College of Veterinary Medicine, Animal Resources and Bio-security Makerere University Lung Institute MRC/UVRI and LSHTM Uganda Research Unit Natural Chemotherapeutics Research Institute