Clinical trial NCT04603690: Oral Curcumin, Quercetin and Vitamin D3 Supplements for Mild to Moderate Symptoms of COVID-19
Official title: Complementary Therapy of Dietary Supplements Curcumin, Quercetin and Vitamin D3 for Mild to Moderate Symptoms of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older, of either gender
* Patients must be tested positive for SARS-CoV-2 by RT-PCR within 72 hours prior to enrolment
* 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 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

Exclusion Criteria:

* 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 suffering patients
* Patients with moderate or severe thrombocytopenia (platelet count \<100 ×10⁹/L);
* Pregnant patients

Primary outcomes:
measure: SARS-CoV-2 Negativity by RT-PCR
timeFrame: up to 14 days
measure: COVID-19 symptoms improvement
timeFrame: up to 7 days
Secondary outcomes:
measure: Improvement in the serum inflammatory marker level
timeFrame: up to 7 days
measure: Improvement in the serum inflammatory marker level
timeFrame: up to 7 days
measure: Improvement in the serum inflammatory marker level
timeFrame: up to 7 days
measure: Improvement in the serum inflammatory marker level
timeFrame: up to 7 days
measure: Hospitalization rate
timeFrame: up to 14 days
measure: Length of hospitalization
timeFrame: up to 14 days
measure: Length of supplementary oxygen therapy
timeFrame: up to 14 days
measure: ICU transfer
timeFrame: up to 14 days
measure: Mechanical ventilation
timeFrame: up to 14 days
measure: All cause mortality
timeFrame: up to 14 days
measure: Safety and tolerability
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Jāmshoro
country: Pakistan
facility: Liaquat University Hospital
state: Sindh
Study officials:
References: