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Study was stopped due to poor accrual.
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| Name | Class |
|---|---|
| Clemson University | OTHER |
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The purpose of this trial is to assess the safety and toxicity profile of the combination of famotidine and oral n-acetyl cysteine in adult outpatients with newly diagnosed SARS-CoV-2 infection.
This is a phase I trial enrolling subjects with newly diagnosed SARS-CoV-2 infection who do not require hospitalization. Exclusion criteria have been written to exclude patients who would be expected to have increased risk from either medication alone. Subjects will be assigned a dose combination of famotidine and n-acetyl cysteine. In addition to assessing the safety and toxicities profiles of the combination of drugs we will be measuring certain endpoints to assess possible efficacy. These endpoint include the following: rates of hospitalization; time to complete remission of symptoms, e.g, fever, respiratory symptoms, etc.; severity of symptoms with validated survey instruments; cytokine values in serum and urine; and markers of inflammation and oxidative stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose N-Acetyl Cysteine Alone | Experimental | N-Acetyl Cysteine 600 mg three times daily |
|
| Medium Dose N-Acetyl Cysteine | Experimental | N-Acetyl Cysteine 1,200 mg three times daily |
|
| Low Dose N-Acetyl Cysteine and Low Dose Famotidine | Experimental | N-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily |
|
| High Dose N-Acetyl Cysteine Alone | Experimental | N-Acetyl Cysteine 1,800 mg three times daily |
|
| Medium Dose N-Acetyl Cysteine and Low Dose Famotidine | Experimental | N-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily |
|
| Low Dose N-Acetyl Cysteine and Medium Dose Famotidine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famotidine | Drug | Oral Famotidine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 | Data will be collected and entered into Case Report Form in local REDCap sever to include MedDRA Code, Grade and all other data required by NIH per Memorandum, "Guidance for Collection of Adverse Events Related to COVID-19 Infection" dated on 25 March 2020. All data will be reported per this memorandum and in accordance with all applicable Institutional Review Board and FDA requirements. | 0 to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Hospitalization | Number of participants hospitalized | 0 to 30 days |
| Time to Symptom Resolution | Days to resolution of symptoms of infection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John J O'Connell, M.D. | Prisma Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health Baptist Easley Hospital | Easley | South Carolina | 29640 | United States | ||
| Prisma Health Greenville Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose N-Acetyl Cysteine Alone | N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose N-Acetyl Cysteine Alone | N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 | Data will be collected and entered into Case Report Form in local REDCap sever to include MedDRA Code, Grade and all other data required by NIH per Memorandum, "Guidance for Collection of Adverse Events Related to COVID-19 Infection" dated on 25 March 2020. All data will be reported per this memorandum and in accordance with all applicable Institutional Review Board and FDA requirements. | Posted | Number | participants | 0 to 30 days |
|
|
From consent to study completion, an average of 30 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose N-Acetyl Cysteine Alone | N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine |
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Decrease in COVID-19 infections in the area followed by other treatment options led to to poor enrollment (n=2) and early termination of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Martin - Director, Cancer Research | Prisma Health | 864-455-3667 | julie.martin@prismahealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2020 | Feb 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015738 | Famotidine |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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N-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily |
|
| High Dose N-Acetyl Cysteine and Low Dose Famotidine | Experimental | N-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily |
|
| Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine | Experimental | N-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily |
|
| Low Dose N-Acetyl Cysteine and High Dose Famotidine | Experimental | N-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily |
|
| High Dose N-Acetyl Cysteine and Medium Dose Famotidine | Experimental | N-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily |
|
| Medium Dose N-Acetyl Cysteine and High Dose Famotidine | Experimental | N-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily |
|
| High Dose N-Acetyl Cysteine and High Dose Famotidine | Experimental | N-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily |
|
|
| N-Acetyl cysteine | Drug | Oral N-Acetyl Cysteine |
|
|
| 0 to 30 days |
| Greenville |
| South Carolina |
| 29605 |
| United States |
| Prisma Health Greer Memorial Hospital | Greer | South Carolina | 29650 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Rate of Hospitalization | Number of participants hospitalized | Posted | Number | participants | 0 to 30 days |
|
|
|
| Secondary | Time to Symptom Resolution | Days to resolution of symptoms of infection. | Posted | Mean | Full Range | days | 0 to 30 days |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |