Acute Respiratory InfectionPhase 2CONATNCT05897203

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

A Phase 2 study testing TAZCOV and Vidicine in people with Acute Respiratory Infection, run by Makerere University at 1 site in Uganda.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Acute Respiratory Infection
What is being tested?: TAZCOV and Vidicine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 510 participants
Where: 1 siteUganda
Study dates: 3 Mar 2023to Jan 2024
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Uganda1 site, 1 recruiting

Mulago National Referral Hospital
Kampala, Central Region
Bruce Kirenga, PhD, 256782404431, brucekirenga@gmail.com
Winters Muttamba, MPH, 256772511261
Recruiting

Other trials in Uganda

About this study

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

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:

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
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
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
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
Being tested: TAZCOV, Vidicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAZCOVDrug
Herbal Syrup
VidicineDrug
Herbal Syrup

Study groups in NCT05897203
Study group	Role	What they receive
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 Receives: Drug: TAZCOV
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 Receives: Drug: Vidicine
Standard of care (SoC)	Other	Participants in this arm will receive only the standard of care Receives: Drug: TAZCOV; Drug: Vidicine

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 9 months
Time to presenting symptom resolution
Will be assessed by time trends in clinical remission of signs and symptoms in the trial arms
Measured: 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
Measured: 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
Measured: 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]
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 2023Jan 2024

First posted9 Jun 2023
Study start3 Mar 2023
Primary completionJan 2024 (estimated)
Study completionJan 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Respiratory InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A phase 2A open-label randomized controlled clinical trial
Masking: Single blind
Who is masked: Participant
Enrolment: 510 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05897203
Sponsor's protocol ID: CONAT
Acronym: CONAT
Status last verified: Jun 2023
First submitted: 25 May 2023
Last updated: 9 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data will be shared with other researchers upon reasonable request through the sponsor

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Respiratory Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05897203
Acronym / sponsor ID: CONAT / CONAT
Conditions: Acute Respiratory Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 510 participants (estimated)
Lead sponsor: Makerere UniversityUniversity, hospital or other
Collaborators: Makerere University Lung Institute, MRC/UVRI and LSHTM Uganda Research Unit, Directorate of Government Analytical Laboratories, Makerere University College of Veterinary Medicine, Animal Resources and Bio-security, Makerere University Biomedical Research Centre, Natural Chemotherapeutics Research Institute
Study start: 3 Mar 2023 (actual)
Primary completion: Jan 2024 (estimated)
Study completion: Jan 2024 (estimated)
First posted: 9 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary objectives include:

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
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
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
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%.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: A phase 2A open-label randomized controlled clinical trial

Arm	Type	Receives
Investigational Medicinal product A (IMP A) + Standard of Care (SoC)	Active comparator	Drug: TAZCOVParticipants in this arm will receive the both the Investigational medicinal product (IMP A) and the standard of care
Investigational Medicinal product B (IMP B) + Standard of Care (SoC)	Active comparator	Drug: VidicineParticipants in this arm will receive the both the Investigational medicinal product (IMP B) and the standard of care
Standard of care (SoC)	Other	Drug: TAZCOV, Drug: VidicineParticipants in this arm will receive only the standard of care

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAZCOVHerbal Syrup	Drug	Investigational Medicinal product A (IMP A) + Standard of Care (SoC), Standard of care (SoC)
VidicineHerbal Syrup	Drug	Investigational Medicinal product B (IMP B) + Standard of Care (SoC), Standard of care (SoC)

Primary outcome

Solicited and unsolicited side effects (mild, moderate, severe, adverse and serious adverse events).
Time frame: 9 months
The outcome measures are cumulative incidences of solicited and unsolicited side effects (mild, moderate, severe adverse events) in the study arms
Time to presenting symptom resolution
Time frame: 14 days
Will be assessed by time trends in clinical remission of signs and symptoms in the trial arms
Days to viral clearance (RT-PCR negativity) for those with a positive viral test at enrolment
Time frame: 7 days
Will be assessed through ascertaining the proportion with negative PCR on days 3, 5 and 7
Progression to severe-critical ARI requiring hospitalization, oxygen therapy and/or mortality
Time frame: 14 days
To be measured by ascertaining the proportion progressing to severe ARI requiring hospitalization, oxygen therapy and/or mortality
Time taken for TazCoV and Vidicine plasma concentration to reach maximum levels [Tmax]
Time frame: 14 days
To be measured by time to maximum concentration of TazCoV and Vidicine plasma [Tmax]

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
Individual participant dataSharing planned: Yes. De-identified data will be shared with other researchers upon reasonable request through the sponsor

Related trials for Acute Respiratory Infection

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mulago National Referral Hospital

Kampala, Uganda

256782404431

brucekirenga@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAZCOV and Vidicine in people with Acute Respiratory Infection, run by Makerere University at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Solicited and unsolicited side effects (mild, moderate, severe, adverse and serious adverse events). (time frame: 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05897203.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.