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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
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:
Outpatients:
- N-acetylcysteine (NAC) 2400 mg PO x 1 then 1200 mg PO BID x 2 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC | Active Comparator | Patients receiving N-acetylcysteine (NAC) |
|
| Control | No Intervention | Patients not receiving N-acetylcysteine (NAC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | Oral formulation: 600 mg capsules of N-acetylcysteine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Respiratory Rate | Decrease in dyspnea measured by respiratory rate (RR) | First hour after first dose of NAC |
| Hospital length of stay (LOS) | Hospital LOS for admitted patients | Through study completion, average 9 months |
| Need for mechanical ventilation | Whether a patient needed mechanical ventilation (intubation) | Through study completion, average 9 months |
| Length of time intubated | If intubated, how long needing mechanical ventilation | Through study completion, average 9 months |
| Need for hospitalization | Outpatients on NAC needing admission to the hospital | Through study completion, average 9 months |
| Recovery disposition | 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 | Through study completion, average 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Cambridge Hospital | Cambridge | Massachusetts | 02138 | United States | ||
| CHA Everett Hospital |
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| Label | URL |
|---|---|
| Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19 | View source |
| Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19 | View source |
| Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19 |
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Information that underlies results in published data
Six months after publication available for a year
Written request; to be reviewed by the PI
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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).
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| Everett |
| Massachusetts |
| 02149 |
| United States |
| CHA Respiratory Clinic | Somerville | Massachusetts | 02143 | United States |
| CHA Somerville campus | Somerville | Massachusetts | 02144 | United States |
| View source |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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