Clinical trial NCT05897203: Clinical Trial of Natural Therapeutics for COVID-19 and Other Acute Respiratory Viral Infections
Official title: Safety, Pharmacokinetics, and Preliminary Efficacy of Herbal Products for the Treatment of Acute Respiratory Viral Infections Including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Uganda; Phase 2A Open Label Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Respiratory Infection
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Makerere University Lung Institute
name: MRC/UVRI and LSHTM Uganda Research Unit
name: Directorate of Government Analytical Laboratories
name: Makerere University College of Veterinary Medicine, Animal Resources and Bio-security
name: Makerere University Biomedical Research Centre
name: Natural Chemotherapeutics Research Institute
First posted: 2023-06-09
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A phase 2A open-label randomized controlled clinical trial
Primary purpose: TREATMENT

Brief 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%.


Eligibility criteria: 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

Primary outcomes:
measure: Solicited and unsolicited side effects (mild, moderate, severe, adverse and serious adverse events).
timeFrame: 9 months
measure: Time to presenting symptom resolution
timeFrame: 14 days
measure: Days to viral clearance (RT-PCR negativity) for those with a positive viral test at enrolment
timeFrame: 7 days
measure: Progression to severe-critical ARI requiring hospitalization, oxygen therapy and/or mortality
timeFrame: 14 days
measure: Time taken for TazCoV and Vidicine plasma concentration to reach maximum levels [Tmax]
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago National Referral Hospital
state: Central
Study officials:
References: