Antioxidant Therapy for COVID-19 Study

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

Interventions

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

Sponsors & Collaborators

• Borno State Ministry of Health

  collaborator UNKNOWN

• Ogun State Ministry of Health

  collaborator UNKNOWN

• Abia State Ministry of Health

  collaborator UNKNOWN

• Sokoto State Ministry of Health

  collaborator UNKNOWN

• Benue State Minsitry of Health

  collaborator UNKNOWN

• University of Calabar Teaching Hospital

  collaborator UNKNOWN

• Obafemi Awolowo University

  lead OTHER

Principal Investigators

• Adeniyi Olagunju, BPharm, MRes, PhD · Obafemi Awolowo University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-01

Primary Completion

2021-02-28

Completion

2021-04-30

Countries

• Nigeria

Study Locations