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The present study is aimed to investigate the treatment benefits of a combination of dietary supplements quercetin, curcumin and vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting.
There is currently no specific early-stage therapeutic treatment available for COVID-19.
Dietary supplements curcumin, quercetin and vitamin D3 have shown strong antioxidant, anti-inflammatory/immunomodulatory and broad-spectrum antiviral effects. The present study is focused to test the combination of oral curcumin, quercetin and vitamin D3 supplements as complementary therapy for outpatients with mild to moderate symptoms of COVID-19 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complementary therapy group | Experimental | This arm will receive a daily supplementation of 168 mg curcumin, 260 mg quercetin and 9 mcg/360 IU of vitamin D3 (cholecalciferol) as add-on to the standard of care for 14-days |
|
| Control group | Active Comparator | This arm will receive standard care alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complementary therapy | Dietary Supplement | A daily supplementation of 168 mg curcumin, 260 mg quercetin and 360 IU of vitamin D3 (cholecalciferol) for 14-days |
|
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 Negativity by RT-PCR | Number of patients testing negative for COVID-19 | up to 14 days |
| COVID-19 symptoms improvement | Number of patients with improvement in COVID-19 acute symptoms | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the serum inflammatory marker level | Changes in the serum CRP level | up to 7 days |
| Improvement in the serum inflammatory marker level | Changes in the serum D-dimer level |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaquat University Hospital | Jāmshoro | Sindh | 76090 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36742008 | Derived | Ujjan ID, Khan S, Nigar R, Ahmed H, Ahmad S, Khan A. The possible therapeutic role of curcumin and quercetin in the early-stage of COVID-19-Results from a pragmatic randomized clinical trial. Front Nutr. 2023 Jan 18;9:1023997. doi: 10.3389/fnut.2022.1023997. eCollection 2022. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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Pilot, randomized, controlled, open-label and pragmatic trial, comparing the treatment benefits of combination of curcumin, quercetin and vitamin D3 supplements as add-on to standard treatment vs. standard therapy, in mild to moderate symptomatic COVID-19 outpatients, within 48 hours, for testing Positive for SARS-CoV-2.
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| Standard of care | Drug | This arm will receive standard of care as per the hospital guidelines |
|
| up to 7 days |
| Improvement in the serum inflammatory marker level | Changes in the serum LDH level | up to 7 days |
| Improvement in the serum inflammatory marker level | Changes in the serum ferritin level | up to 7 days |
| Hospitalization rate | Number of patients required hospitalization | up to 14 days |
| Length of hospitalization | Number of hospital admission days | up to 14 days |
| Length of supplementary oxygen therapy | Patients requirement oxygen at during hospitalization | up to 14 days |
| ICU transfer | Numbers of patients progressing to ICU | up to 14 days |
| Mechanical ventilation | Numbers of patients requiring mechanical ventilation at hospital | up to 14 days |
| All cause mortality | Numbers of hospital mortality | up to 14 days |
| Safety and tolerability | Any adverse event due to the investigational treatment | up to 14 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |