Pharmacologic Ascorbic Acid as an Activator of Lymphocyte Signaling for COVID-19 Treatment

• Status: Not yet recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

There are currently no approved therapies for patients with coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Infusion of ascorbic acid (vitamin C) has been shown to increase activity of lymphocytes, which are a crucial component of the body's defense against viral disease progression and adaptive immunity. Ascorbic acid infusion has been shown to be a safe treatment for patients suffering from sepsis and certain types of cancer. This study is designed to evaluate the safety and efficacy of ascorbic acid in the form of sequential I.V. infusions (Ascor®) for patients with suspected COVID-19 who are unlikely to require mechanical ventilation within 24 hours of study intervention.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Ascorbic Acid

Criteria

Inclusion Criteria:

1. Male or non-pregnant female > 18 years of age at the time of consent

2. ConfirmedSARS-CoV-2 infection

3. Disease severity necessitating hospitalization

4. Currently taking supplemental oxygen

5. No anticipated need (within 24 hours) for mechanical ventilation, defined as:

1. Positive clinical response to oxygen supplementation with improvement in hypoxia or

2. Hypoxia improvement with bronchospasm therapy if bronchospasm present

Exclusion Criteria

1. eGFR < 50

2. Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency

3. Anticipated need for mechanical ventilation within 24 hours

4. Pregnant or breastfeeding

5. Requires home oxygen for any reason