<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04466657</url>
  </required_header>
  <id_info>
    <org_study_id>GSHSOD-COVID2020</org_study_id>
    <nct_id>NCT04466657</nct_id>
  </id_info>
  <brief_title>Antioxidant Therapy for COVID-19 Study</brief_title>
  <acronym>GSHSOD-COVID</acronym>
  <official_title>A Study to Evaluate Antioxidant Therapy for Moderate to Severe COVID-19 With or Without Comorbidities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Obafemi Awolowo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Borno State Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ogun State Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Abia State Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sokoto State Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Benue State Minsitry of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Calabar Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Obafemi Awolowo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Finding effective strategies to treat or prevent the novel coronavirus disease that started&#xD;
      in 2019 (COVID-19) is a global public health priority. Potential therapeutics and vaccines&#xD;
      are now being investigated in over 1500 clinical trials. Clinical features of the disease&#xD;
      include overproduction of reactive oxygen species which induces oxidative stress responses&#xD;
      and contribute to acute lung injury. This presents a potential treatment strategy involving&#xD;
      antioxidation therapy. In this pilot study, 90 COVID-19 patients aged 18-75 years will be&#xD;
      recruited into two groups. The 45 patients in group 1 will receive the standard of care&#xD;
      determined by their primary care providers while the 45 patients in group 2 will receive both&#xD;
      the standard of care combined with daily antioxidant supplement for 14 days. All patients&#xD;
      will be monitored for a total of 28 days with daily monitoring of symptoms and nasopharyngeal&#xD;
      swab for SARS-CoV-2 test on days 3, 7, 14 and 28. The study will compare the following&#xD;
      between the two groups: (1) the proportion of patients with clinical improvement (defined as&#xD;
      live discharge from hospital, decrease of at least 2 points from baseline on a 7-point&#xD;
      ordinal scale, or both), and (2) the proportion of patients with negative SARS-CoV-2 test by&#xD;
      PCR on days 3, 7, and 14.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: COVID-19 caused by SARS-CoV-2 is an unprecedented global public health challenge&#xD;
      which as at 06 May 2020 has spread to over 210 with over 3.6 million cases including 250,000&#xD;
      deaths. More than 1500 clinical trials are currently ongoing in an unprecedented global&#xD;
      search for potential therapeutics and vaccines. Certain clinical features of SARS-CoV-2&#xD;
      infection provide potential treatment strategies involving antioxidation therapy, including&#xD;
      overproduction of reactive oxygen species which induces oxidative stress responses and&#xD;
      contribute to acute lung injury.&#xD;
&#xD;
      Primary Outcome Measure: (1) the proportion of patients with clinical improvement (defined as&#xD;
      live discharge from hospital, decrease of at least 2 points from baseline on a 7-point&#xD;
      ordinal scale, or both), and (2) the proportion of patients with negative SARS-CoV-2 test by&#xD;
      PCR on days 3, 7, and 14.&#xD;
&#xD;
      Study Design: Individuals within 18-75 years of age who receive a PCR positive test for&#xD;
      COVID-19 and admitted at participating COVID-19 isolation and treatment centres will be&#xD;
      invited to participate. Consenting individuals will be randomised 1:1 to receive either&#xD;
      standard of care alone (control group) or standard of care plus daily antioxidant&#xD;
      supplementation (intervention group). A total of 90 participants will be recruited in the&#xD;
      Pilot Stage (n = 45 per arm). The Pivotal Stage will include 300 participants. Antioxidant&#xD;
      therapy will be a formulation composed of reduced GSH, N-acetylcysteine, superoxide dismutase&#xD;
      and bovine lactoferrin and immunoglobulin as in whey protein isolate. Clinical improvement&#xD;
      will be evaluated daily using a 7-category ordinal scale. SARS-CoV-2 PCR test will be&#xD;
      repeated on days 3, 7, 14 and 28.&#xD;
&#xD;
      Analysis: An interim analysis of data from the Pilot Stage will be conducted after the first&#xD;
      45 participants have completed days 1-14 of the study period. These data will provide&#xD;
      valuable insights regarding possible revision of the design, conduct and analysis of the&#xD;
      Pivotal Stage. Analysis of clinical improvement based on the 7-category ordinal scale will be&#xD;
      performed using time-to-event data (patients will censored at 28-days of follow-up).&#xD;
      Categorical variables will be analysed using the log-rank test and continuous variables will&#xD;
      be assessed using a univariable Cox proportional hazard regression analysis. Proportion of&#xD;
      participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at days 3, 7, 14&#xD;
      and 28 will be compared between the intervention and control groups.&#xD;
&#xD;
      Ethics: This trial will be conducted in compliance with the protocol, the principles of ICH&#xD;
      Guideline E6 for Good Clinical Practice, the Declaration of Helsinki, and all applicable&#xD;
      regulatory requirements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study halted prematurely, prior to enrollment of first participant&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 1, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to clinical improvement</measure>
    <time_frame>28 days</time_frame>
    <description>Time to clinical improvement (defined as time from randomization to either an improvement of two points on a 7-category ordinal scale or discharge from the hospital, whichever came first, or both)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to SARS-CoV-2 negativity</measure>
    <time_frame>14 days</time_frame>
    <description>Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at Day 14</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical status on day 14</measure>
    <time_frame>14 days</time_frame>
    <description>Clinical status as assessed with the seven-category ordinal scale on day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with SARS-CoV-2 PCR negative result at Day 7</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with SARS-CoV-2 PCR negative result at Day 28</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28 Day mortality</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization in survivors</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from treatment initiation to death</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events during treatment</measure>
    <time_frame>28 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>28 days</time_frame>
    <description>Respiratory failure or Acute Respiratory Distress Syndrome, Acute Kidney Injury, secondary infection, shock, severe anemia, acute gastritis, unconsciousness, acute heart failure</description>
  </other_outcome>
  <other_outcome>
    <measure>Gastrointesntinal adverse events</measure>
    <time_frame>28 days</time_frame>
    <description>Nausea, vomiting, and diarrhea</description>
  </other_outcome>
  <other_outcome>
    <measure>Discontinuation of trial intervention before the end of protocol specified 14 days</measure>
    <time_frame>14 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Standard of Care (SOC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will receive SOC alone, which will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOC plus Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive SOC plus daily antioxidant supplement composed of two proprietary formulations that include reduced glutathione, N-acetylcysteine, superoxide dismutase, and bovine lactoferrin and immunoglobulins.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Antioxidation Therapy</intervention_name>
    <description>Two proprietary formulations composed of reduced glutathione, N-acetylcysteine, superoxide dismutase, and bovine lactoferrin and immunoglobulins.</description>
    <arm_group_label>SOC plus Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>SOC will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19</description>
    <arm_group_label>SOC plus Intervention</arm_group_label>
    <arm_group_label>Standard of Care (SOC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide informed consent prior to any study procedures&#xD;
&#xD;
          -  Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by&#xD;
             polymerase chain reaction (PCR) test ≤ 2 days before randomization&#xD;
&#xD;
          -  Currently hospitalized and requiring medical care for COVID-19&#xD;
&#xD;
          -  Peripheral capillary oxygen saturation (SpO2) &lt; 94% on room air at screening&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Participation in any other clinical trial of an experimental treatment for COVID-19&#xD;
&#xD;
          -  Concurrent treatment with other agents outside the standard of care than 24 hours&#xD;
             prior to study intervention dosing&#xD;
&#xD;
          -  Requiring mechanical ventilation at screening&#xD;
&#xD;
          -  Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times upper&#xD;
             limit of normal (ULN)&#xD;
&#xD;
          -  Creatinine clearance &lt; 50 mL/min using the Cockcroft-Gault formula&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adeniyi Olagunju, BPharm, MRes, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Obafemi Awolowo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abia State Isolation Centre, Amachara</name>
      <address>
        <city>Umuahia</city>
        <state>Abia State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benue State University Teaching Hospital</name>
      <address>
        <city>Makurdi</city>
        <state>Benue State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigadier Abba Kyari Memorial Hospital</name>
      <address>
        <city>Borno</city>
        <state>Borno State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maiduguri Teaching Hospital</name>
      <address>
        <city>Maiduguri</city>
        <state>Borno State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calabar Teaching Hospital</name>
      <address>
        <city>Calabar</city>
        <state>Cross River</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal Medical Centre Idi-Aba</name>
      <address>
        <city>Abeokuta</city>
        <state>Ogun State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olabisi Onabanjo University Teaching Hospital</name>
      <address>
        <city>Sagamu</city>
        <state>Ogun State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infectious Disease Hospital</name>
      <address>
        <city>Amanawa</city>
        <state>Sokoto State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Murtala Muhammad Speciaist Hospital</name>
      <address>
        <city>Sokoto</city>
        <state>Sokoto State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Occupational Therapy Center</name>
      <address>
        <city>Sokoto</city>
        <state>Sokoto State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Usmanu Danfodiyo University Teaching Hospital</name>
      <address>
        <city>Sokoto</city>
        <state>Sokoto State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <reference>
    <citation>Yuki K, Fujiogi M, Koutsogiannaki S. COVID-19 pathophysiology: A review. Clin Immunol. 2020 Jun;215:108427. doi: 10.1016/j.clim.2020.108427. Epub 2020 Apr 20.</citation>
    <PMID>32325252</PMID>
  </reference>
  <reference>
    <citation>Imai Y, Kuba K, Neely GG, Yaghubian-Malhami R, Perkmann T, van Loo G, Ermolaeva M, Veldhuizen R, Leung YH, Wang H, Liu H, Sun Y, Pasparakis M, Kopf M, Mech C, Bavari S, Peiris JS, Slutsky AS, Akira S, Hultqvist M, Holmdahl R, Nicholls J, Jiang C, Binder CJ, Penninger JM. Identification of oxidative stress and Toll-like receptor 4 signaling as a key pathway of acute lung injury. Cell. 2008 Apr 18;133(2):235-49. doi: 10.1016/j.cell.2008.02.043.</citation>
    <PMID>18423196</PMID>
  </reference>
  <reference>
    <citation>Hosakote YM, Jantzi PD, Esham DL, Spratt H, Kurosky A, Casola A, Garofalo RP. Viral-mediated inhibition of antioxidant enzymes contributes to the pathogenesis of severe respiratory syncytial virus bronchiolitis. Am J Respir Crit Care Med. 2011 Jun 1;183(11):1550-60. doi: 10.1164/rccm.201010-1755OC. Epub 2011 Mar 4.</citation>
    <PMID>21471094</PMID>
  </reference>
  <reference>
    <citation>Lin X, Wang R, Zou W, Sun X, Liu X, Zhao L, Wang S, Jin M. The Influenza Virus H5N1 Infection Can Induce ROS Production for Viral Replication and Host Cell Death in A549 Cells Modulated by Human Cu/Zn Superoxide Dismutase (SOD1) Overexpression. Viruses. 2016 Jan 8;8(1):13. doi: 10.3390/v8010013.</citation>
    <PMID>26761025</PMID>
  </reference>
  <reference>
    <citation>Cao W, Liu X, Bai T, Fan H, Hong K, Song H, Han Y, Lin L, Ruan L, Li T. High-Dose Intravenous Immunoglobulin as a Therapeutic Option for Deteriorating Patients With Coronavirus Disease 2019. Open Forum Infect Dis. 2020 Mar 21;7(3):ofaa102. doi: 10.1093/ofid/ofaa102. eCollection 2020 Mar.</citation>
    <PMID>32258207</PMID>
  </reference>
  <reference>
    <citation>Sinha R, Sinha I, Calcagnotto A, Trushin N, Haley JS, Schell TD, Richie JP Jr. Oral supplementation with liposomal glutathione elevates body stores of glutathione and markers of immune function. Eur J Clin Nutr. 2018 Jan;72(1):105-111. doi: 10.1038/ejcn.2017.132. Epub 2017 Aug 30.</citation>
    <PMID>28853742</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>October 29, 2021</last_update_submitted>
  <last_update_submitted_qc>October 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV infection</keyword>
  <keyword>COVID-19</keyword>
  <keyword>coronavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04466657
org study id: GSHSOD-COVID2020
nct id: NCT04466657
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Finding effective strategies to treat or prevent the novel coronavirus disease that started
      in 2019 (COVID-19) is a global public health priority. Potential therapeutics and vaccines
      are now being investigated in over 1500 clinical trials. Clinical features of the disease
      include overproduction of reactive oxygen species which induces oxidative stress responses
      and contribute to acute lung injury. This presents a potential treatment strategy involving
      antioxidation therapy. In this pilot study, 90 COVID-19 patients aged 18-75 years will be
      recruited into two groups. The 45 patients in group 1 will receive the standard of care
      determined by their primary care providers while the 45 patients in group 2 will receive both
      the standard of care combined with daily antioxidant supplement for 14 days. All patients
      will be monitored for a total of 28 days with daily monitoring of symptoms and nasopharyngeal
      swab for SARS-CoV-2 test on days 3, 7, 14 and 28. The study will compare the following
      between the two groups: (1) the proportion of patients with clinical improvement (defined as
      live discharge from hospital, decrease of at least 2 points from baseline on a 7-point
      ordinal scale, or both), and (2) the proportion of patients with negative SARS-CoV-2 test by
      PCR on days 3, 7, and 14.
Background: COVID-19 caused by SARS-CoV-2 is an unprecedented global public health challenge
      which as at 06 May 2020 has spread to over 210 with over 3.6 million cases including 250,000
      deaths. More than 1500 clinical trials are currently ongoing in an unprecedented global
      search for potential therapeutics and vaccines. Certain clinical features of SARS-CoV-2
      infection provide potential treatment strategies involving antioxidation therapy, including
      overproduction of reactive oxygen species which induces oxidative stress responses and
      contribute to acute lung injury.

      Primary Outcome Measure: (1) the proportion of patients with clinical improvement (defined as
      live discharge from hospital, decrease of at least 2 points from baseline on a 7-point
      ordinal scale, or both), and (2) the proportion of patients with negative SARS-CoV-2 test by
      PCR on days 3, 7, and 14.

      Study Design: Individuals within 18-75 years of age who receive a PCR positive test for
      COVID-19 and admitted at participating COVID-19 isolation and treatment centres will be
      invited to participate. Consenting individuals will be randomised 1:1 to receive either
      standard of care alone (control group) or standard of care plus daily antioxidant
      supplementation (intervention group). A total of 90 participants will be recruited in the
      Pilot Stage (n = 45 per arm). The Pivotal Stage will include 300 participants. Antioxidant
      therapy will be a formulation composed of reduced GSH, N-acetylcysteine, superoxide dismutase
      and bovine lactoferrin and immunoglobulin as in whey protein isolate. Clinical improvement
      will be evaluated daily using a 7-category ordinal scale. SARS-CoV-2 PCR test will be
      repeated on days 3, 7, 14 and 28.

      Analysis: An interim analysis of data from the Pilot Stage will be conducted after the first
      45 participants have completed days 1-14 of the study period. These data will provide
      valuable insights regarding possible revision of the design, conduct and analysis of the
      Pivotal Stage. Analysis of clinical improvement based on the 7-category ordinal scale will be
      performed using time-to-event data (patients will censored at 28-days of follow-up).
      Categorical variables will be analysed using the log-rank test and continuous variables will
      be assessed using a univariable Cox proportional hazard regression analysis. Proportion of
      participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at days 3, 7, 14
      and 28 will be compared between the intervention and control groups.

      Ethics: This trial will be conducted in compliance with the protocol, the principles of ICH
      Guideline E6 for Good Clinical Practice, the Declaration of Helsinki, and all applicable
      regulatory requirements.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Time to clinical improvement
time frame: 28 days
description: Time to clinical improvement (defined as time from randomization to either an improvement of two points on a 7-category ordinal scale or discharge from the hospital, whichever came first, or both)
measure: Time to SARS-CoV-2 negativity
time frame: 14 days
description: Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at Day 14
measure: Clinical status on day 14
time frame: 14 days
description: Clinical status as assessed with the seven-category ordinal scale on day 14
measure: Proportion of participants with SARS-CoV-2 PCR negative result at Day 7
time frame: 7 days
measure: Proportion of participants with SARS-CoV-2 PCR negative result at Day 28
time frame: 28 days
measure: 28 Day mortality
time frame: 28 days
measure: Duration of hospitalization in survivors
time frame: 28 days
measure: Time from treatment initiation to death
time frame: 28 days
measure: Adverse events during treatment
time frame: 28 days
measure: Serious adverse events
time frame: 28 days
description: Respiratory failure or Acute Respiratory Distress Syndrome, Acute Kidney Injury, secondary infection, shock, severe anemia, acute gastritis, unconsciousness, acute heart failure
measure: Gastrointesntinal adverse events
time frame: 28 days
description: Nausea, vomiting, and diarrhea
measure: Discontinuation of trial intervention before the end of protocol specified 14 days
time frame: 14 days
arm group label: Standard of Care (SOC)
arm group type: Active Comparator
description: Participants in this arm will receive SOC alone, which will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19
arm group label: SOC plus Intervention
arm group type: Experimental
description: Participants in this arm will receive SOC plus daily antioxidant supplement composed of two proprietary formulations that include reduced glutathione, N-acetylcysteine, superoxide dismutase, and bovine lactoferrin and immunoglobulins.
intervention type: Dietary Supplement
intervention name: Antioxidation Therapy
description: Two proprietary formulations composed of reduced glutathione, N-acetylcysteine, superoxide dismutase, and bovine lactoferrin and immunoglobulins.
arm group label: SOC plus Intervention
intervention type: Other
intervention name: Standard of Care
description: SOC will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19
arm group label: SOC plus Intervention
arm group label: Standard of Care (SOC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Adeniyi Olagunju, BPharm, MRes, PhD
role: Study Chair
affiliation: Obafemi Awolowo University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Nigeria
citation: Yuki K, Fujiogi M, Koutsogiannaki S. COVID-19 pathophysiology: A review. Clin Immunol. 2020 Jun;215:108427. doi: 10.1016/j.clim.2020.108427. Epub 2020 Apr 20.
PMID: 32325252
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responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No