The trial "Safety, Pharmacokinetics and Preliminary Efficacy of herbal products for thetreatment of acute respiratory viral infections including SARS-CoV2 in Uganda; Phase 2AOpen Label Clinical Trial" is currently being implemented under the Clinical Trials ofNatural therapeutics Program. The trial sample size is 510, and the participants includeadults (18 years or more) who fulfill the case definitions of acute respiratoryinfections (ARI), test positive for one of the target respiratory viruses, are negativefor TB on GeneXpert; non-pregnant/non-breast-feeding females, have no history ofhypersensitivity to any of the investigational products, and have given written consentto participate in the trial.The overall objective of the trial is to assess the safety, pharmacokinetics andpreliminary efficacy of TazCoV and Vidicine for the treatment of acute respiratory viralinfections 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%.
Not Provided
Drug: TAZCOV
Herbal Syrup
Drug: Vidicine
Herbal Syrup
Inclusion Criteria: ALl adults who
- fulfill ARI case definition
- have signs and symptoms of ARI
- test positive for one of the target respiratory viruses (SARS-CoV2, RSV, or
Influenza A/B)
- do not have symptoms suggestive of Pulmonary TB i.e cough for more than 2 weeks,
drenching night sweats, evening fevers and marked weight loss.
- can provide informed consent or have a surrogate or legally appointed representative
to give consent
Exclusion Criteria:
- Severe acute respiratory illness (SARI)-defined as An acute respiratory illness with
a history of fever or measured fever of ≥ 38 °C and cough and/or throat with onset
within the past 10 days, requiring hospitalization or with SPO2≤92%
- History of hypersensitivity to the investigational product or components therein
- Conditions that may be regarded as contraindications to the investigational
medicinal product include known allergic reactions and rashes to any herbal
medicines and any untoward reactions to any herbal medications such as bleeding,
headaches, high blood pressure, heart failure, seizures, agitation, etc.
- Severe organ impairment (liver, kidney, brain, heart)
- Inability to return for post-discharge follow-up
- Females who are pregnant or intend to become pregnant or are breastfeeding during
the trial
Mulago National Referral Hospital
Kampala, Central, Uganda
Investigator: Bruce Kirenga, PhD
Contact: 256782404431
brucekirenga@gmail.com
Not Provided