COVID-19NCT05130671
Nutritional Supplementation of Flavonoids Quercetin and Curcumin for Early Mild Symptoms of COVID-19
A study testing Investigational treatment in people with COVID-19, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
The purpose of this study is to investigate the therapeutic benefits of flavonoids nutritional supplements quercetin and curcumin for early mild symptoms of COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Investigational treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Oct 2021to 31 Dec 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years of age or older, of either gender
- Patients must be tested positive for SARS-CoV-2 by RT-PCR
- Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes withshaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
- Patients must be in the early stage of COVID-19 disease who do not require hospitalization at the time of screening
- Patients must be under the care of a Physician for diagnosis of COVID-19
- Patients who have signed informed consent
Who cannot join
- Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin
- Patients with known chronic kidney disease with estimated creatinine clearance < 50 mL/minute or need for dialysis
- Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
- Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.
- Patients with gallstone obstruction
- Hypothyroid suppering patients
- Patients with moderate or severe thrombocytopenia (platelet count <100 ×10⁹/L);
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
King Edward Medical University Teaching Hospital
Lahore, Punjab Province, 54000
About this study
Official title: Treatment Benefits of Flavonoids Quercetin and Curcumin Supplements for Mild Symptoms of COVID-19
The purpose of this study is to investigate the therapeutic benefits of flavonoids nutritional supplements quercetin and curcumin for early mild symptoms of COVID-19.
Read the detailed description
Flavonoids nutritional supplements quercetin and curcumin have demonstrated strong antioxidant, broad-spectrum anti-viral and anti-inflammatory properties including against the respiratory tract infections. They are widely used to boost the immunity against infections and keeping healthy life-style. Results from recent published studies have shown positive results for quercetin and curcumin in patients with COVID-19.
In the present study the investigators aim to study the combined beneficial effects of quercetin and curcumin in addition to standard of care for managing early mild symptoms of COVID-19 in community-based patients.
- Conditions
- COVID-19
- Being tested
- Standard of care, Investigational treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careDrug
Standard of care treatment as per the hospital guidelines
Investigational treatmentDietary supplement
Combination of quercetin and curcumin as add-on to the standard of care
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | This arm will receive the standard of care as per the hospital guidelines. Receives: Drug: Standard of care |
| Investigational treatment | Experimental | This arm will receive combination of nutritional supplements quercetin and curcumin as add-on to the standard of care. Receives: Drug: Standard of care; Dietary Supplement: Investigational treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing negative for SARS-CoV-2 by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Testing of naso-pharyngeal swab for COVID-19
Measured: Day 7
COVID-19 symptoms improvement
Improvement of the typical symptoms associated with COVID-19 infection
Measured: Day 7
Secondary outcomes (5)
Improvement in CRP level
Improvement in the CRP levels
Measured: Day 7
Improvement in D-dimers level
Improvement in D-dimers level
Measured: Day 7
Improvement in LDH levels
Improvement in LDH levels
Measured: Day 7
Improvement in ferritin levels
Improvement in Ferritin levels
Measured: Day 7
Improvement in full blood count (CBC)
Improvement in CBC levels
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start25 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, somia iqtadar, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130671
- Sponsor's protocol ID
- 785/RC/KEMU/25.10.2021
- Status last verified
- Jan 2022
- First submitted
- 21 Nov 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khan A, Iqtadar S, Mumtaz SU, Heinrich M, Pascual-Figal DA, Livingstone S, Abaidullah S. Oral Co-Supplementation of Curcumin, Quercetin, and Vitamin D3 as an Adjuvant Therapy for Mild to Moderate Symptoms of COVID-19-Results From a Pilot Open-Label, Randomized Controlled Trial. Front Pharmacol. 2022 Jun 7;13:898062. doi: 10.3389/fphar.2022.898062. eCollection 2022.
PubMed 35747751
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Benefits of Flavonoids Quercetin and Curcumin Supplements for Mild Symptoms of COVID-19
- ClinicalTrials.gov ID
- NCT05130671
- Acronym / sponsor ID
- 785/RC/KEMU/25.10.2021
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Nov 2021 (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.
The purpose of this study is to investigate the therapeutic benefits of flavonoids nutritional supplements quercetin and curcumin for early mild symptoms of COVID-19.
Detailed description
Flavonoids nutritional supplements quercetin and curcumin have demonstrated strong antioxidant, broad-spectrum anti-viral and anti-inflammatory properties including against the respiratory tract infections. They are widely used to boost the immunity against infections and keeping healthy life-style. Results from recent published studies have shown positive results for quercetin and curcumin in patients with COVID-19.
In the present study the investigators aim to study the combined beneficial effects of quercetin and curcumin in addition to standard of care for managing early mild symptoms of COVID-19 in community-based patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Drug: Standard of careThis arm will receive the standard of care as per the hospital guidelines. |
| Investigational treatment | Experimental | Drug: Standard of care, Dietary Supplement: Investigational treatmentThis arm will receive combination of nutritional supplements quercetin and curcumin as add-on to the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be 18 years of age or older, of either gender
- Patients must be tested positive for SARS-CoV-2 by RT-PCR
- Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes withshaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
- Patients must be in the early stage of COVID-19 disease who do not require hospitalization at the time of screening
- Patients must be under the care of a Physician for diagnosis of COVID-19
Key exclusion criteria (8 listed)
- Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin
- Patients with known chronic kidney disease with estimated creatinine clearance < 50 mL/minute or need for dialysis
- Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
- Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.
- Patients with gallstone obstruction
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 |
|---|---|---|
| Standard of careStandard of care treatment as per the hospital guidelines | Drug | Investigational treatment, Standard of care |
| Investigational treatmentCombination of quercetin and curcumin as add-on to the standard of care | Dietary supplement | Investigational treatment |
Primary outcome
Testing negative for SARS-CoV-2 by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Time frame: Day 7
Testing of naso-pharyngeal swab for COVID-19
COVID-19 symptoms improvement
Time frame: Day 7
Improvement of the typical symptoms associated with COVID-19 infection
5 secondary outcomes
Improvement in CRP level
Time frame: Day 7
Improvement in D-dimers level
Time frame: Day 7
Improvement in LDH levels
Time frame: Day 7
Improvement in ferritin levels
Time frame: Day 7
Improvement in full blood count (CBC)
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Derived from this study: PubMed 35747751Khan A, Iqtadar S, Mumtaz SU, Heinrich M, Pascual-Figal DA, Livingstone S, Abaidullah S. Oral Co-Supplementation of Curcumin, Quercetin, and Vitamin D3 as an Adjuvant Therapy for Mild to Moderate Symptoms of COVID-19-Results From a Pilot Open-Label, Randomized Controlled Trial. Front Pharmacol. 2022 Jun 7;13:898062. doi: 10.3389/fphar.2022.898062. eCollection 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational treatment in people with COVID-19, run by King Edward Medical University at 1 site in Pakistan.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jan 2022. 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 Pakistan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing negative for SARS-CoV-2 by Reverse Transcription Polymerase Chain Reaction (RT-PCR) (time frame: Day 7). The study lists 2 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 NCT05130671, which also lists 1 linked publication.
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 28 Jan 2022.