Antioxidant Therapy for COVID-19 Study (GSHSOD-COVID)
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| ClinicalTrials.gov Identifier: NCT04466657 |
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Recruitment Status :
Withdrawn
(Study halted prematurely, prior to enrollment of first participant)
First Posted : July 10, 2020
Last Update Posted : November 8, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Covid-19 | Dietary Supplement: Antioxidation Therapy Other: Standard of Care | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 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 |
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
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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.
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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 |
- 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)
- 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
- Clinical status on day 14 [ Time Frame: 14 days ]Clinical status as assessed with the seven-category ordinal scale on day 14
- Proportion of participants with SARS-CoV-2 PCR negative result at Day 7 [ Time Frame: 7 days ]
- Proportion of participants with SARS-CoV-2 PCR negative result at Day 28 [ Time Frame: 28 days ]
- 28 Day mortality [ Time Frame: 28 days ]
- Duration of hospitalization in survivors [ Time Frame: 28 days ]
- Time from treatment initiation to death [ Time Frame: 28 days ]
- Adverse events during treatment [ Time Frame: 28 days ]
- 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
- Gastrointesntinal adverse events [ Time Frame: 28 days ]Nausea, vomiting, and diarrhea
- Discontinuation of trial intervention before the end of protocol specified 14 days [ Time Frame: 14 days ]
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.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Nigeria | |
| Abia State Isolation Centre, Amachara | |
| Umuahia, Abia State, Nigeria | |
| Benue State University Teaching Hospital | |
| Makurdi, Benue State, Nigeria | |
| Brigadier Abba Kyari Memorial Hospital | |
| Borno, Borno State, Nigeria | |
| University of Maiduguri Teaching Hospital | |
| Maiduguri, Borno State, Nigeria | |
| University of Calabar Teaching Hospital | |
| Calabar, Cross River, Nigeria | |
| Federal Medical Centre Idi-Aba | |
| Abeokuta, Ogun State, Nigeria | |
| Olabisi Onabanjo University Teaching Hospital | |
| Sagamu, Ogun State, Nigeria | |
| Infectious Disease Hospital | |
| Amanawa, Sokoto State, Nigeria | |
| Murtala Muhammad Speciaist Hospital | |
| Sokoto, Sokoto State, Nigeria | |
| Occupational Therapy Center | |
| Sokoto, Sokoto State, Nigeria | |
| Usmanu Danfodiyo University Teaching Hospital | |
| Sokoto, Sokoto State, Nigeria | |
| Study Chair: | Adeniyi Olagunju, BPharm, MRes, PhD | Obafemi Awolowo University |
Publications:
| 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: | November 8, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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SARS-CoV infection COVID-19 coronavirus |
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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |