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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04558424
Recruitment Status : Not yet recruiting
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
elora sharmin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Condition or disease Intervention/treatment Phase
Covid19 Dietary Supplement: zinc gluconate and ascorbic acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
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
Primary Purpose: Supportive Care
Official Title: Randomized, Double -Blind, Placebo Controlled, Trial to Evaluate the Effect of Zinc and Ascorbic Acid Supplementation in COVID-19 Positive Hospitalized Patients in BSMMU
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: Intervention group
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
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.

Placebo Comparator: Placebo group
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
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Symptom Resolution: Fever [ Time Frame: 28 days ]
    The number of days required to reach a score of 0 from the symptom category of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102.6

  2. Symptom Resolution: Cough [ Time Frame: 28 days ]
    The number of days required to reach a score of 0 from the symptom category of cough based on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe

  3. Symptom Resolution: Fatigue [ Time Frame: 28 days ]
    The number of days required to reach a score of 0 from the symptom category of shortness of breath based on a 0-3 scale: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities

  4. Symptom Resolution: Muscle/body aches [ Time Frame: 28 days ]
    The number of days required to reach a score of 0 from the symptom category of muscle/body aches based on a 0-3 scale: 1=mild muscle/body aches, 2=moderate muscle/body aches , 3=severe muscle/body aches.

  5. Symptom Resolution: Headache [ Time Frame: 28 days ]
    The number of days required to reach a score of 0 from the symptom category of headache based on a 0-3 scale: 1=mild headache, 2=moderate headache, 3=severe headache.

  6. Symptom Resolution: New loss of taste [ Time Frame: 28 days ]
    The number of days required to reach a score of 0 from the symptom category of new loss of taste based on a 0-3 scale: 1=mild loss of taste, 2=moderate loss of taste, 3=severe loss of taste.

  7. Symptom Resolution: New loss of smell [ Time Frame: 28 days ]
    The number of days required to reach a score of 0 from the symptom category of new loss of smell based on a 0-3 scale: 1=mild loss of smell, 2=moderate loss of smell, 3=severe loss of smell.

  8. Symptom Resolution: Congestion/ runny nose [ Time Frame: 28 days ]
    The number of days required to reach a score of 0 from the symptom category of congestion/runny nose on a 0-3 scale: 1=mild congestion/runny nose , 2=moderate congestion/runny nose , 3=severe congestion/runny nose .

  9. Symptom Resolution: Nausea [ Time Frame: 28 days ]
    The number of days required to reach a score of 0 from the symptom category of nausea on a 0-3 scale: 1=mild nausea, 2=moderate nausea, 3=severe nausea.

  10. Symptom Resolution: Vomiting [ Time Frame: 28 days ]
    The number of days required to reach a score of 0 from the symptom category of vomiting on a 0-3 scale: 1=mild vomiting, 2=moderate vomiting, 3=severe vomiting.

  11. Symptom Resolution: Diarrhea [ Time Frame: 28 days ]
    The number of days required to reach a score of 0 from the symptom category of diarrhea on a 0-3 scale: 1=mild diarrhea, 2=moderate diarrhea, 3=severe diarrhea.

  12. Day 5 Symptoms [ Time Frame: 28 days ]
    Total symptom composite score at day 5 of study supplementation: Symptom categories of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102; Cough on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe; Shortness of Breath on a 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities; and Fatigue on a 0-3 scale: 0 = No fatigue/energetic, 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.

  13. Severity of Symptoms [ Time Frame: 28 days ]
    Differences in severity of symptoms between study arms

  14. Adjunctive Medications [ Time Frame: 28 days ]
    Differences in number of patients who were prescribed adjunctive medications for their diagnosis between study arms

  15. Supplementation Side Effects [ Time Frame: 28 days ]
    Differences in number of patients in study arms who experienced side effects from the supplements.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558424


Contacts
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Contact: elora sharmin, MD 01914499800 elora.sharmin@bsmmu.edu.bd
Contact: Prof. Dr. Shohael Mahmud Arafat Prof. Dr. Shohael Mahmud Arafat, FCPS

Locations
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Bangladesh
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
Contact: elora sharmin, MD    01914499800    elora.sharmin@bsmmu.edu.bd   
Contact: Shohael Mahmud Arafat, FCPS         
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Principal Investigator: sharmin bangabandhu sheikh mujib medical unuversity
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Responsible Party: elora sharmin, assistant professor, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT04558424    
Other Study ID Numbers: BSMMU 2020
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with the journal authority and make public as part of the publication
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: six month
Access Criteria: Available on public domain like figshare, researchgate and others

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances