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| Name | Class |
|---|---|
| Makerere University Lung Institute | UNKNOWN |
| MRC/UVRI and LSHTM Uganda Research Unit | OTHER |
| Directorate of Government Analytical Laboratories | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Medicinal product A (IMP A) + Standard of Care (SoC) | Active Comparator | Participants in this arm will receive the both the Investigational medicinal product (IMP A) and the standard of care |
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| Investigational Medicinal product B (IMP B) + Standard of Care (SoC) | Active Comparator | Participants in this arm will receive the both the Investigational medicinal product (IMP B) and the standard of care |
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| Standard of care (SoC) | Other | Participants in this arm will receive only the standard of care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAZCOV | Drug | Herbal Syrup |
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| Measure | Description | Time Frame |
|---|---|---|
| Solicited and unsolicited side effects (mild, moderate, severe, adverse and serious adverse events). | The outcome measures are cumulative incidences of solicited and unsolicited side effects (mild, moderate, severe adverse events) in the study arms | 9 months |
| Time to presenting symptom resolution | Will be assessed by time trends in clinical remission of signs and symptoms in the trial arms | 14 days |
| Days to viral clearance (RT-PCR negativity) for those with a positive viral test at enrolment | Will be assessed through ascertaining the proportion with negative PCR on days 3, 5 and 7 | 7 days |
| Progression to severe-critical ARI requiring hospitalization, oxygen therapy and/or mortality | To be measured by ascertaining the proportion progressing to severe ARI requiring hospitalization, oxygen therapy and/or mortality | 14 days |
| Time taken for TazCoV and Vidicine plasma concentration to reach maximum levels [Tmax] | To be measured by time to maximum concentration of TazCoV and Vidicine plasma [Tmax] | 14 days |
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Inclusion Criteria: ALl adults who
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulago National Referral Hospital | Recruiting | Kampala | Central Region | Uganda |
De-identified data will be shared with other researchers upon reasonable request through the sponsor
2 years after trial end
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| Makerere University College of Veterinary Medicine, Animal Resources and Bio-security |
| UNKNOWN |
| Makerere University Biomedical Research Centre | UNKNOWN |
| Natural Chemotherapeutics Research Institute | UNKNOWN |
A phase 2A open-label randomized controlled clinical trial
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| Vidicine | Drug | Herbal Syrup |
|