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Antioxidant Therapy for COVID-19 Study (GSHSOD-COVID)

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: NCT04466657
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
Borno State Ministry of Health
Ogun State Ministry of Health
Abia State Ministry of Health
Sokoto State Ministry of Health
Benue State Minsitry of Health
University of Calabar Teaching Hospital
Information provided by (Responsible Party):
Obafemi Awolowo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid-19 Dietary Supplement: Antioxidation Therapy Other: Standard of Care Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Study to Evaluate Antioxidant Therapy for Moderate to Severe COVID-19 With or Without Comorbidities
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
Active Comparator: Standard of Care (SOC)
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
Other: Standard of Care
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

Experimental: SOC plus Intervention
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.
Dietary Supplement: Antioxidation Therapy
Two proprietary formulations composed of reduced glutathione, N-acetylcysteine, superoxide dismutase, and bovine lactoferrin and immunoglobulins.

Other: Standard of Care
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




Primary Outcome Measures :
  1. Time to clinical improvement [ Time Frame: 28 days ]
    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)

  2. Time to SARS-CoV-2 negativity [ Time Frame: 14 days ]
    Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at Day 14


Secondary Outcome Measures :
  1. Clinical status on day 14 [ Time Frame: 14 days ]
    Clinical status as assessed with the seven-category ordinal scale on day 14

  2. Proportion of participants with SARS-CoV-2 PCR negative result at Day 7 [ Time Frame: 7 days ]
  3. Proportion of participants with SARS-CoV-2 PCR negative result at Day 28 [ Time Frame: 28 days ]
  4. 28 Day mortality [ Time Frame: 28 days ]
  5. Duration of hospitalization in survivors [ Time Frame: 28 days ]
  6. Time from treatment initiation to death [ Time Frame: 28 days ]

Other Outcome Measures:
  1. Adverse events during treatment [ Time Frame: 28 days ]
  2. Serious adverse events [ Time Frame: 28 days ]
    Respiratory failure or Acute Respiratory Distress Syndrome, Acute Kidney Injury, secondary infection, shock, severe anemia, acute gastritis, unconsciousness, acute heart failure

  3. Gastrointesntinal adverse events [ Time Frame: 28 days ]
    Nausea, vomiting, and diarrhea

  4. Discontinuation of trial intervention before the end of protocol specified 14 days [ Time Frame: 14 days ]


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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide informed consent prior to any study procedures
  • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 2 days before randomization
  • Currently hospitalized and requiring medical care for COVID-19
  • Peripheral capillary oxygen saturation (SpO2) < 94% on room air at screening

Exclusion Criteria

  • Participation in any other clinical trial of an experimental treatment for COVID-19
  • Concurrent treatment with other agents outside the standard of care than 24 hours prior to study intervention dosing
  • Requiring mechanical ventilation at screening
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times upper limit of normal (ULN)
  • Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula

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): NCT04466657


Contacts
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Contact: Adeniyi Olagunju, BPharm, MRes, PhD +234906 885 8698 aeolagunju@oauife.edu.ng

Locations
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Nigeria
Abia State Isolation Centre, Amachara
Umuahia, Abia State, Nigeria
Contact: Ijeoma Nduka, MBBS    +2347063041311    drijnduka@yahoo.com   
Contact: Franklin Alozie         
Benue State University Teaching Hospital
Makurdi, Benue State, Nigeria
Contact: Audu Onyemocho, MBBS    +234803 452 2249    audeeony@yahoo.com   
Contact: Patrick Echekwube, MBBS, FMCP    +234803 679 1574    pechekwube@gmail.com   
Brigadier Abba Kyari Memorial Hospital
Borno, Borno State, Nigeria
Contact: Ibrahim M Ngulde, MBChB         
Contact    +2348062122937    nguldedr@yahoo.com   
University of Maiduguri Teaching Hospital
Maiduguri, Borno State, Nigeria
Contact: Ibrahim M Kida, MBBS    +2348030997944    imkidah@yahoo.com   
University of Calabar Teaching Hospital
Calabar, Cross River, Nigeria
Contact: Ofem Enang, MBBS    +234803 318 9568    ofemenang07@gmail.com   
Federal Medical Centre Idi-Aba
Abeokuta, Ogun State, Nigeria
Contact: Gloria B Imhonopi, MBBS, MPH, FMCPH    +2348055269433    gimhonopi@gmail.com   
Olabisi Onabanjo University Teaching Hospital
Sagamu, Ogun State, Nigeria
Contact: Bolanle Adefuye, MBBS    +234802 385 1428    bolaadefuye@yahoo.com   
Contact: Festus Soyinka, MBBS    +2348033478503    fosoyinka@yahoo.com   
Infectious Disease Hospital
Amanawa, Sokoto State, Nigeria
Contact: Sirajo Haliru, MBBS    +2348036003395    stambuwal@gmail.com   
Murtala Muhammad Speciaist Hospital
Sokoto, Sokoto State, Nigeria
Contact: Usman M Bello, MBBS    +2347068188280    usmankebbe@yahoo.co.uk   
Occupational Therapy Center
Sokoto, Sokoto State, Nigeria
Usmanu Danfodiyo University Teaching Hospital
Sokoto, Sokoto State, Nigeria
Contact: Zainu Sabitu, MBBS    +2348063605252    zsabitu@gmail.com   
Sponsors and Collaborators
Obafemi Awolowo University
Borno State Ministry of Health
Ogun State Ministry of Health
Abia State Ministry of Health
Sokoto State Ministry of Health
Benue State Minsitry of Health
University of Calabar Teaching Hospital
Investigators
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Study Chair: Adeniyi Olagunju, BPharm, MRes, PhD Obafemi Awolowo University
Additional Information:
Publications:

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Responsible Party: Obafemi Awolowo University
ClinicalTrials.gov Identifier: NCT04466657    
Other Study ID Numbers: GSHSOD-COVID2020
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Obafemi Awolowo University:
SARS-CoV infection
COVID-19
coronavirus