Clinical Trial of Natural Therapeutics for COVID-19 and Other Acute Respiratory Viral Infections

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%.

Conditions

• Acute Respiratory Infection

Interventions

DRUG

TAZCOV

Herbal Syrup

DRUG

Vidicine

Herbal Syrup

Sponsors & Collaborators

• Makerere University Lung Institute

  collaborator UNKNOWN

• MRC/UVRI and LSHTM Uganda Research Unit

  collaborator OTHER

• Directorate of Government Analytical Laboratories

  collaborator UNKNOWN

• Makerere University College of Veterinary Medicine, Animal Resources and Bio-security

  collaborator UNKNOWN

• Makerere University Biomedical Research Centre

  collaborator UNKNOWN

• Natural Chemotherapeutics Research Institute

  collaborator UNKNOWN

• Makerere University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-03

Primary Completion

2024-01-31

Completion

2024-01-31

Countries

• Uganda

Study Locations