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Clinical Trials/NCT04558424
NCT04558424UnknownNot Applicable

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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 site in 1 country50 target enrollmentStarted: October 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
symptoms reduction time frame

Study Overview

Brief 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.

Detailed Description

In view of the emerging COVID-19 pandemic caused by SARS-coV-2 virus, the search for potential protective and therapeutic antiviral strategies is of particular and urgent interest. Despite the lack of clinical data, certain indications suggest that modulation of zinc status may be beneficial in COVID-19. The use of vitamin C could be effective in terms of mortality and outcomes in patients with covid-19 pneumonia. Zinc and vitamin C are the over the counter supplementation and other study shows the effect of this in respiratory tract infection. This type of study is not done in Bangladesh. So, this will give a baseline data for further study which will help the researcher.

C. Related with socio-economic development: Health economic analysis will be done by total duration of hospital stay in comparing with total cost during admission in hospital. Benefits of this analysis will consider the:

  • Reduced the severity and symptoms which will decrease the risk of mortality among the patients.
  • Duration of hospital stay will reduce the treatment cost and as well the price of this nutrients supplements is very low.
  • Costs are measured by the recorded number of patients and duration of hospital stay in both study groups. Number and duration will be recorded.
  1. Work plan:

Methodology Types of study: Randomized double-blind placebo Controlled Trial Place of study: Department of pharmacology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Immediately after randomization, random numbers of the two sets will assigned as patients code number. One set will be designated as intervention group and another group will placebo group. Two sets of code number that belongs to the intervention group and placebo group will be written with patient's id number. this total procedure will be conducted by the person unrelated to this research. Thus, the participants, caregiver, outcome assessor and the analyst, who require being blind for such study will effectively blind

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ≥ 18 years presenting symptoms who test positive for COVID-19
  • Moderate to severe patients obtained consent
  • Hypoxic respiratory failure (saturation <90% on air at rest or increasing oxygen requirement)
  • Chest examination findings of bilateral crackles on auscultation or chest x-ray showing bilateral infiltrates
  • C-Reactive Protein > 50mg/L
  • women of childbearing potential who meet the above and have a negative pregnancy test.

Exclusion Criteria

  • Pregnant women: Current known pregnancy positive pregnancy test.
  • Lactating women.
  • Documented history of mental illnesses
  • Multi-organ failure
  • Severe ARDS (requiring ventilator support on presentation in the form of invasive or non-invasive ventilation)
  • Septic Shock
  • Drug allergy/intolerance

Outcomes

Primary Outcomes

symptoms reduction time frame

Time Frame: 28 days

Number of days to reach a 50 percent reduction in the cumulative 0-36 symptom score with each symptom evaluated on a 0-3 scale. Assessed symptoms are Fever, Cough, Shortness of Breath, Fatigue, Muscle or body aches, Headache, New loss of taste, New loss of smell, Congestion or runny nose, Nausea, Vomiting, Diarrhea. Each patient will have a composite score ranging from 0-36/day

Secondary Outcomes

  • Symptom Resolution: Congestion/ runny nose(28 days)
  • Symptom Resolution: Nausea(28 days)
  • Severity of Symptoms(28 days)
  • Symptom Resolution: Fever(28 days)
  • Symptom Resolution: Cough(28 days)
  • Symptom Resolution: Fatigue(28 days)
  • Symptom Resolution: Muscle/body aches(28 days)
  • Symptom Resolution: Headache(28 days)
  • Symptom Resolution: New loss of taste(28 days)
  • Symptom Resolution: New loss of smell(28 days)
  • Symptom Resolution: Vomiting(28 days)
  • Symptom Resolution: Diarrhea(28 days)
  • Adjunctive Medications(28 days)
  • Supplementation Side Effects(28 days)
  • Day 5 Symptoms(28 days)

Investigators

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

elora sharmin

assistant professor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Sites (1)

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