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

NCT04363216 | Unknown Phase 2

• 1 other identifier: JT#15681
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COVID-19

Keywords

ascorbic acid; vitamin c

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement

  • Clinical improvement at 72 hours of treatment, defined as a 50% reduction in the highest flow rate of oxygen during the 72 hour period, a 50% reduction in the most frequent use of bronchodilators within a 12-hour window within the 72-hour period, or hospital discharge (whichever comes first).

  72 hours

Secondary Outcomes (5)

• Patient status upgraded to ICU level [Clinical decline]

  36 hours

• Oxygen supplementation

  up to 1 year

• Days with fever

  up to 1 year

• Days to discharge

  up to 1 year

• SAEs

  up to 1 year

Study Arms (2)

Treatment

EXPERIMENTAL

Ascorbic acid solution (Ascor®, McGuff Pharmaceuticals, Ltd.) will be added to each liter of sterile wate,r plus 1 g/L magnesium chloride to reduce burning sensation, and given parenterally over a 2-hour period. On the day of enrollment (Day 0), 0.3 g/kg will be given; Day 1 - 0.6 g/kg; Day 2 - 0.9 g/kg; Day 3 - 0.9 g/kg; Day 4 - 0.9 g/kg; Day 5 - 0.9 g/kg. After the first dose, each subsequent dose will be given 24 +/- 4 hours following the previous dose.

Drug: Ascorbic Acid

Routine care

NO INTERVENTION

These subject will follow routine care and their clinical courses will be recorded only.

Interventions

Ascorbic Acid DRUG

Ascor® ascorbic acid 2-hour infusion daily (for 6 days), escalating dose (0.3g/kg, 0.6g/kg, 0.9g/kg).

Also known as: Vitamin C

Treatment

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant female \> 18 years of age at the time of consent
• ConfirmedSARS-CoV-2 infection
• Disease severity necessitating hospitalization
• Currently taking supplemental oxygen
• No anticipated need (within 24 hours) for mechanical ventilation, defined as:
• Positive clinical response to oxygen supplementation with improvement in hypoxia or
• Hypoxia improvement with bronchospasm therapy if bronchospasm present

You may not qualify if:

• eGFR \< 50
• Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Anticipated need for mechanical ventilation within 24 hours
• Pregnant or breastfeeding
• Requires home oxygen for any reason

Sponsors & Collaborators

• Thomas Jefferson University: lead

MeSH Terms

Conditions

COVID-19

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Dagan Coppock, M.D.

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Daniel Monti, M.D.

  Thomas Jefferson University

  STUDY DIRECTOR

Central Study Contacts

Michael W Foster, M.D.

CONTACT

6107160962; mxf314@jefferson.edu

Melissa McCarey

CONTACT

267 503-7417; melissa.mccarey@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share