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Trial · Interventional

WithdrawnNot applicableRegistry data

Antioxidant Therapy for COVID-19 Study

Short name GSHSOD-COVID

NCTNCT04466657 (opens ClinicalTrials.gov in a new tab)Other idGSHSOD-COVID2020
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Glutathione, does not test it. It appears in the description.

Overview

Status
Withdrawn
Phase
Not applicable
Enrollment
0 participants (actual)
Sponsor
Obafemi Awolowo University · Other
Design
Randomized · Single masking
Countries
1 country

Nigeria

Start
1 Nov 2020 (estimated)
Primary completion
28 Feb 2021 (estimated)
Completion
30 Apr 2021 (estimated)
First posted
10 Jul 2020
Last update posted
8 Nov 2021
Conditions
Covid-19

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022
  1. N/A

    GSHSOD-COVID

    NCT04466657

    est. 1 Nov 2020 to est. 30 Apr 2021

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Antioxidation TherapyDietary supplement
  • Standard of CareOther

Arms2

  • 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

  • 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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Time to clinical improvement

    Time frame · 28 days

    Registry 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)

  2. Time to SARS-CoV-2 negativity

    Time frame · 14 days

    Registry description

    Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at Day 14

Secondary outcomes(6)

  1. Clinical status on day 14

    Time frame · 14 days

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2018

9 results

Oral supplementation with liposomal glutathione elevates body stores of glutathione and markers of immune function.

Sinha et al. 2018European journal of clinical nutritioncited by 68

PMID 28853742PMC6389332DOI 10.1038/ejcn.2017.132PUB-28853742

Rights unknown9 results
Source linkSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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