COVID, Oxidative Stress, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Sars-CoV2
Conditions
Keywords
Glutathione, Acetylcysteine, Oxidative stress, NAC, COVID, COVID-19, SARS-CoV2
Brief summary
The purpose of this study is to assess the efficacy of N-acetylcysteine (NAC) in preventing those with mild or moderate COVID-19 from progressing to severe disease
Detailed description
After being informed of the study and potential risks and benefits, patients meeting eligibility requirements will be randomized to receive oral N-acetylcysteine (NAC) as follows: Inpatients: * N-acetylcystine (NAC) 25 mg/kg PO (rounded up to the nearest 600 mg) q4hrs until discharge * N-acetylcysteine (NAC) 1200 mg PO BID x 1 week post-discharge Outpatients: \- N-acetylcysteine (NAC) 2400 mg PO x 1 then 1200 mg PO BID x 2 weeks
Interventions
DRUGN-acetylcysteine
Oral formulation: 600 mg capsules of N-acetylcysteine
Sponsors
Cambridge Health Alliance
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are assigned to one of two groups in parallel for the duration of the study. One arm is the intervention arm - those receiving N-acetylcysteine (NAC). One arm is the control group - those not receiving N-acetylcysteine (NAC).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* known or suspect COVID-19 disease AND one or more of the following influenza-like symptoms, including: diarrhea vomiting fever (subjective or measured) chills myalgias fatigue sore throat headache cough nasal/sinus congestion or rhinorrhea shortness of breath chest pain
Exclusion criteria
* Minors, pregnant women and people unable to provide informed consent are excluded from this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay (LOS) | Through study completion, average 9 months | Hospital LOS for admitted patients |
| Decrease in Respiratory Rate | First hour after first dose of NAC | Decrease in dyspnea measured by respiratory rate (RR) |
| Need for mechanical ventilation | Through study completion, average 9 months | Whether a patient needed mechanical ventilation (intubation) |
| Length of time intubated | Through study completion, average 9 months | If intubated, how long needing mechanical ventilation |
| Need for hospitalization | Through study completion, average 9 months | Outpatients on NAC needing admission to the hospital |
| Recovery disposition | Through study completion, average 9 months | Whether outpatients continued to recover as outpatients; whether admitted patients were managed on medical floors or level of care increased to ICU level of care; whether patients expired |
Countries
United States
Outcome results
None listed