RCT,Double Blind, Placebo to Evaluate the Effect of Zinc and Ascorbic Acid Supplementation in COVID-19 Positive Hospitalized Patients in BSMMU

Summary

The first COVID-19 case was identified on March 7, 2020. Since then, 4127 deaths of the total 3,40583 confirmed cases are reported in Bangladesh of August 26, 2020. this new virus there has been an increase in the number of pneumonia, which are characterized by fever, sore throat ,asthenia, dry cough, lymphopenia, prolonged prothrombin time, elevated lactic dehydrogenase and CRP and a tomographic imaging indicative of interstitial pneumonia (ground glass and patchy shadows). Severe disease occurs in 15% of the cases with COVID-19 and may progress to critical disease in only 5% of the cases with a high risk of mortality. Critical disease may present as acute respiratory failure secondary to Acute Respiratory Distress Syndrome mainstay of treatment is supportive. Recent studies have shown the efficacy of vitamin C and Zinc administration in patients hospitalized for sepsis in the setting of intensive wards in terms of mortality reduction. The use of vitamin C arises from the experimental evidence of its anti-inflammatory and antioxidant properties. Zinc is known to modulate antiviral and antibacterial immunity and regulate inflammatory response. Zn may possess protective effect as preventive and adjuvant therapy of COVID-19 through reducing inflammation, improvement of mucociliary clearance, prevention of ventilator induced lung injury, modulation of antiviral and antibacterial immunity. Severity assessment tools for identifying patients at risk of deterioration due to sepsis. The quick Sequential (Sepsis-related) Organ Failure Assessment tool is the recommended tool to screen patients with suspected infection outside the intensive care unit (one point for each of altered mentation, respiratory rate ≥22 and systolic blood pressure ≤100 mmHg, with a score ≥2 suggesting high risk for deterioration).More generic tools designed to predict deterioration regardless of etiology have also been designed, such as the National Early Warning Score , widely used in the English National Health Service, Access alertness, RR, blood pressure , heart rate, oxygen saturation and temperature with increasing values for more abnormal measurements. A score of ≥3 in any category or score ≥5 overall triggers urgent patient review.D isease specific tools, such as CURB65, are recommended by respiratory societies worldwide.Each of altered mentation, blood urea \>7.0, RR ≥30, SBP \<90 or diastolic BP ≤60 and age ≥65 scores one point, with scores ≥2 considered moderate- severe.

Conditions

• Covid19

Interventions

DIETARY_SUPPLEMENT

zinc gluconate and ascorbic acid

This group will consist of 50 patients who will receive 220 mg zinc and 1gm ascorbic acid for 10 days in addition to their standard treatment.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  lead OTHER

Principal Investigators

• sharmin · bangabandhu sheikh mujib medical unuversity

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-01

Primary Completion

2021-09-01

Completion

2021-09-01

Countries

• Bangladesh

Study Locations