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

NCT04558424 | Unknown DMC

• 1 other identifier: BSMMU 2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• symptoms reduction time frame

  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

  28 days

Secondary Outcomes (15)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

This group will consist of 50 patients who will be treated with zinc and vitamin C at a dose of 220 mg and 1 gram orally daily for 10 days in addition to their standard treatment

Dietary Supplement: zinc gluconate and ascorbic acid

Placebo group

PLACEBO COMPARATOR

This group will consist of 50 patients who will receive placebo at a dose same dose for 10 days in addition to their standard treatment.

Dietary Supplement: zinc gluconate and ascorbic acid

Interventions

zinc gluconate and ascorbic acid DIETARY_SUPPLEMENT

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.

Intervention group; Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

COVID-19

Interventions

gluconic acid; Ascorbic Acid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• sharmin

  bangabandhu sheikh mujib medical unuversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

elora sharmin, MD

CONTACT

01914499800; elora.sharmin@bsmmu.edu.bd

Prof. Dr. Shohael Mahmud Arafat Prof. Dr. Shohael Mahmud Arafat, FCPS

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Criteria 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

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 22, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: six month
• Access Criteria: Available on public domain like figshare, researchgate and others

Locations

BA (1)