Antioxidant Therapy for COVID-19 Study

NCT04466657 | Withdrawn

• 1 other identifier: GSHSOD-COVID2020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 11

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.

Conditions

Covid-19

Keywords

SARS-CoV infection; COVID-19; coronavirus

Outcome Measures

Primary Outcomes (2)

• Time to clinical improvement

  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)

  28 days

• Time to SARS-CoV-2 negativity

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

  14 days

Secondary Outcomes (6)

• Clinical status on day 14

  14 days

• Proportion of participants with SARS-CoV-2 PCR negative result at Day 7

  7 days

• Proportion of participants with SARS-CoV-2 PCR negative result at Day 28

  28 days

• 28 Day mortality

  28 days

• Duration of hospitalization in survivors

  28 days

Other Outcomes (4)

• Adverse events during treatment

  28 days

• Serious adverse events

  28 days

• Gastrointesntinal adverse events

  28 days

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

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 plus Intervention

EXPERIMENTAL

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; Other: Standard of Care

Interventions

Antioxidation Therapy DIETARY_SUPPLEMENT

Two proprietary formulations composed of reduced glutathione, N-acetylcysteine, superoxide dismutase, and bovine lactoferrin and immunoglobulins.

SOC plus Intervention

Standard of Care OTHER

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

SOC plus Intervention; Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Obafemi Awolowo University: lead
• Borno State Ministry of Health: collaborator
• Ogun State Ministry of Health: collaborator
• Abia State Ministry of Health: collaborator
• Sokoto State Ministry of Health: collaborator
• Benue State Minsitry of Health: collaborator
• University of Calabar Teaching Hospital: collaborator

Study Sites (11)

Abia State Isolation Centre, Amachara

Umuahia, Abia State, Nigeria

Location

Benue State University Teaching Hospital

Makurdi, Benue State, Nigeria

Location

Brigadier Abba Kyari Memorial Hospital

Borno, Borno State, Nigeria

Location

University of Maiduguri Teaching Hospital

Maiduguri, Borno State, Nigeria

Location

University of Calabar Teaching Hospital

Calabar, Cross River State, Nigeria

Location

Federal Medical Centre Idi-Aba

Abeokuta, Ogun State, Nigeria

Location

Olabisi Onabanjo University Teaching Hospital

Sagamu, Ogun State, Nigeria

Location

Infectious Disease Hospital

Ammanawa, Sokoto State, Nigeria

Location

Murtala Muhammad Speciaist Hospital

Sokoto, Sokoto State, Nigeria

Location

Occupational Therapy Center

Sokoto, Sokoto State, Nigeria

Location

Usmanu Danfodiyo University Teaching Hospital

Sokoto, Sokoto State, Nigeria

Location

Related Publications (6)

• 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 BACKGROUND

• 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.

  PMID: 18423196 BACKGROUND

• 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.

  PMID: 21471094 BACKGROUND

• 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.

  PMID: 26761025 BACKGROUND

• 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.

  PMID: 32258207 BACKGROUND

• 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.

  PMID: 28853742 BACKGROUND

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Coronavirus Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Adeniyi Olagunju, BPharm, MRes, PhD

  Obafemi Awolowo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 10, 2020
• Study Start: November 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: April 30, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

NG (11)