Vit D3 for Early Symptoms of COVID-19

Study Overview
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Brief Summary
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This study is aimed to investigate the treatment vitamin D3 as complementary therapy with routine care for early mild symptoms of COVID-19 in outpatients setting.

Detailed Description
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There is currently no specific early-stage therapeutic treatment available for COVID-19. Vitamin D3 is a strong antioxidant, and anti-inflammatory/immunomodulatory agent. The present study is aimed to investigate the treatment benefits of vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting.

Official Title
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Vit D3 Adjuvant Therapy for Early Mild Symptoms of COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Drug: Standard of care
* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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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 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 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 suppering patients Patients with moderate or severe thrombocytopenia (platelet count <100 ×10⁹/L); Pregnant patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>This arm will receive the standard of care as per the hospital guidelines. | Drug: Standard of care<br>* Standard of care treatment as per the hospital guidelines<br>|
| Experimental: Investigational treatment<br>This arm will receive vitamin D3 supplement as add-on to the standard of care. | Drug: Standard of care<br>* Standard of care treatment as per the hospital guidelines<br>Dietary Supplement: Vitamin D3<br>* A daily dose of 5000 IU vitamin D3 for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 Negativity by RT-PCR | The numbers of patients that tests COVID-19 negative | From day 1 to day 14 | 
| COVID-19 symptoms improvement | The numbers of patients whose COVID-19 symptoms are subsided | From day 1 to day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CRP level | Improvement in blood CRP level | From day 1 to day 14 | 
| Changes in D-dimer level | Improvement in blood D-dimer level | From day 1 to day 14 | 
| Changes in LDH level | Improvement in blood LDH level | From day 1 to day 14 | 
| Changes in ferritin level | Improvement in blood ferritin level | From day 1 to day 14 | 
| Changes in full blood count | Improvement in full blood count | From day 1 to day 14 |