Natural treatments for COVID-19 and other respiratory infections
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
This study is testing if herbal products TazCoV and Vidicine can help adults in Uganda who have COVID-19 or other respiratory infections feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 510 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Makerere University Academic / other |
| Locations | 1 site (Kampala, Central) |
| Trial ID | NCT05897203 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, pharmacokinetics, and preliminary efficacy of herbal products, specifically TazCoV and Vidicine, for treating acute respiratory viral infections, including SARS-CoV2, RSV, and Influenza A/B, in Uganda. The study involves 510 adult participants who meet specific criteria for acute respiratory infections and have tested positive for one of the target viruses. Participants must also be free from tuberculosis symptoms and provide informed consent to participate. The trial aims to gather data on the effectiveness of these natural therapeutics in managing respiratory infections.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have tested positive for acute respiratory viral infections and meet the study's inclusion criteria.
Not a fit: Patients with severe acute respiratory illness requiring hospitalization or those with a history of hypersensitivity to the investigational products may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide new, effective natural treatment options for patients suffering from acute respiratory viral infections.
How similar studies have performed: While there have been various studies on herbal treatments for respiratory infections, this specific approach focusing on TazCoV and Vidicine is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kampala, Central
- Mulago National Referral Hospital — Kampala, Central, Uganda (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.