COVID-19NCT04861298
Study to Investigate the Clinical Benefits of Dietary Supplement Quercetin for Managing Early Mild Symptoms of COVID-19
A study testing Quercetin Phytosome (QP) in people with COVID-19, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Quercetin is a flavonoid dietary supplement that occurs in many edible fruits and vegetables. It has remarkable antioxidant, anti-inflammatory, immunoprotective and antiviral properties. It is widely used to boost the body immune system against infections and keeping healthy life-style. 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?
- Quercetin Phytosome (QP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Jan 2021to 29 Aug 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 with shaking, 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 hospitalisation 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
- 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 with moderate or severe thrombocytopenia (platelet count <100 × 10⁹/L);
- Pregnant patients
- Patients declining to participate
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: Study to Investigate the Benefits of Dietary Supplement Quercetin for Early Symptoms of COVID-19
Quercetin is a flavonoid dietary supplement that occurs in many edible fruits and vegetables. It has remarkable antioxidant, anti-inflammatory, immunoprotective and antiviral properties. It is widely used to boost the body immune system against infections and keeping healthy life-style. The purpose of the present study is to investigate the potential benefits of quercetin for preventing COVID-19 disease progression and symptoms improvement in the early stage of infection.
Read the detailed description
The strong antioxidant and anti-inflammatory properties of quercetin are closely related to its effective fight against a variety of disease conditions related to inflammation, including: viral infections, allergies, asthma, hay fever, arthritis, respiratory diseases, "hardening of the arteries" (atherosclerosis), high cholesterol, heart disease and circulation problems, insulin resistance and diabetes, eye-related disorders, including cataracts, stomach ulcers, cognitive impairment, gout, cancer, chronic fatigue syndrome, inflammation of the prostate, bladder, and ovaries, chronic infections of the prostate, skin disorders, including dermatitis and hives. Quercetin can help stop damaging particles in the body known as free radicals, which damages the cells by natural oxidation processes. It can also reduce the expression of inflammatory genes in the cells.
Quercetin has been shown to be effective against broad range of viruses including human respiratory syncytial virus (hRSV), rhinovirus, echovirus, coxsackievirus, poliovirus, parainfluenza type 3, Herpes Simplex Virus-1, cytomegalovirus, SARS-CoV-1, dengue virus, and Hepatitis C virus.
The purpose of the present study is to investigate the potential benefits of quercetin for preventing COVID-19 disease progression and improving symptoms in the early stage of infection.
- Conditions
- COVID-19
- Being tested
- standard of care for COVID-19 as per the hospital guidelines, Quercetin Phytosome (QP)
- 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 care for COVID-19 as per the hospital guidelinesDrug
Hospital standard of care treatment for COVID-19
Quercetin Phytosome (QP)Dietary supplement
Daily dose of 600 mg of Quercetin for 1st week and then 400 mg for the 2nd week
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (SOC) | Active comparator | This arm will receive the standard of care (SOC) for COVID-19 as per the hospital guidelines. Receives: Drug: standard of care for COVID-19 as per the hospital guidelines |
| Quercetin | Experimental | This arm will receive standard of care + oral Quercetin for two weeks Receives: Drug: standard of care for COVID-19 as per the hospital guidelines; Dietary Supplement: Quercetin Phytosome (QP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing negative for SARS-CoV-2 by RT-PCR with symptoms improvement
Measured: From day 1 to day 14
Secondary outcomes (6)
Percentage of subjects that require hospitalisation
Measured: From day 1 to day 14
Improvement in CRP
Measured: From day 1 to day 14
Improvement in D-Dimers
Measured: From day 1 to day 14
Improvement in LDH
Measured: From day 1 to day 14
Improvement in Ferritin
Measured: From day 1 to day 14
Improvement in CBC
Measured: From day 1 to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start11 Jan 2021
- Primary completion29 Aug 2021
- Study completion29 Aug 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861298
- Sponsor's protocol ID
- 192/RC/KEMU
- Status last verified
- Jan 2022
- First submitted
- 25 Apr 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Pierro F, Khan A, Iqtadar S, Mumtaz SU, Chaudhry MNA, Bertuccioli A, Derosa G, Maffioli P, Togni S, Riva A, Allegrini P, Recchia M, Zerbinati N. Quercetin as a possible complementary agent for early-stage COVID-19: Concluding results of a randomized clinical trial. Front Pharmacol. 2023 Jan 13;13:1096853. doi: 10.3389/fphar.2022.1096853. eCollection 2022.
PubMed 36712674
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Benefits of Dietary Supplement Quercetin for Early Symptoms of COVID-19
- ClinicalTrials.gov ID
- NCT04861298
- Acronym / sponsor ID
- 192/RC/KEMU
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 29 Aug 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 27 Apr 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.
Quercetin is a flavonoid dietary supplement that occurs in many edible fruits and vegetables. It has remarkable antioxidant, anti-inflammatory, immunoprotective and antiviral properties. It is widely used to boost the body immune system against infections and keeping healthy life-style. The purpose of the present study is to investigate the potential benefits of quercetin for preventing COVID-19 disease progression and symptoms improvement in the early stage of infection.
Detailed description
The strong antioxidant and anti-inflammatory properties of quercetin are closely related to its effective fight against a variety of disease conditions related to inflammation, including: viral infections, allergies, asthma, hay fever, arthritis, respiratory diseases, "hardening of the arteries" (atherosclerosis), high cholesterol, heart disease and circulation problems, insulin resistance and diabetes, eye-related disorders, including cataracts, stomach ulcers, cognitive impairment, gout, cancer, chronic fatigue syndrome, inflammation of the prostate, bladder, and ovaries, chronic infections of the prostate, skin disorders, including dermatitis and hives. Quercetin can help stop damaging particles in the body known as free radicals, which damages the cells by natural oxidation processes. It can also reduce the expression of inflammatory genes in the cells.
Quercetin has been shown to be effective against broad range of viruses including human respiratory syncytial virus (hRSV), rhinovirus, echovirus, coxsackievirus, poliovirus, parainfluenza type 3, Herpes Simplex Virus-1, cytomegalovirus, SARS-CoV-1, dengue virus, and Hepatitis C virus.
The purpose of the present study is to investigate the potential benefits of quercetin for preventing COVID-19 disease progression and improving symptoms in the early stage of infection.
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 (SOC) | Active comparator | Drug: standard of care for COVID-19 as per the hospital guidelinesThis arm will receive the standard of care (SOC) for COVID-19 as per the hospital guidelines. |
| Quercetin | Experimental | Drug: standard of care for COVID-19 as per the hospital guidelines, Dietary Supplement: Quercetin Phytosome (QP)This arm will receive standard of care + oral Quercetin for two weeks |
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 with shaking, 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 hospitalisation at the time of screening
- Patients must be under the care of a Physician for diagnosis of COVID-19
Key exclusion criteria (6 listed)
- Patients with proven hypersensitivity or allergic reaction to quercetin
- 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 with moderate or severe thrombocytopenia (platelet count <100 × 10⁹/L);
- Pregnant patients
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 care for COVID-19 as per the hospital guidelinesHospital standard of care treatment for COVID-19 | Drug | Quercetin, Standard of care (SOC) |
| Quercetin Phytosome (QP)Daily dose of 600 mg of Quercetin for 1st week and then 400 mg for the 2nd week | Dietary supplement | Quercetin |
Primary outcome
Testing negative for SARS-CoV-2 by RT-PCR with symptoms improvement
Time frame: From day 1 to day 14
6 secondary outcomes
Percentage of subjects that require hospitalisation
Time frame: From day 1 to day 14
Improvement in CRP
Time frame: From day 1 to day 14
Improvement in D-Dimers
Time frame: From day 1 to day 14
Improvement in LDH
Time frame: From day 1 to day 14
Improvement in Ferritin
Time frame: From day 1 to day 14
Improvement in CBC
Time frame: From day 1 to day 14
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 7 Feb 2022.
- Derived from this study: PubMed 36712674Di Pierro F, Khan A, Iqtadar S, Mumtaz SU, Chaudhry MNA, Bertuccioli A, Derosa G, Maffioli P, Togni S, Riva A, Allegrini P, Recchia M, Zerbinati N. Quercetin as a possible complementary agent for early-stage COVID-19: Concluding results of a randomized clinical trial. Front Pharmacol. 2023 Jan 13;13:1096853. doi: 10.3389/fphar.2022.1096853. eCollection 2022.
- Individual participant dataSharing planned: No
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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 Quercetin Phytosome (QP) 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 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: finished, as of the sponsor's last update on 7 Feb 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 RT-PCR with symptoms improvement (time frame: From day 1 to day 14). 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 NCT04861298, 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 7 Feb 2022.