Covid19
Conditions
Keywords
outpatient, famotidine, n-acetyl cysteine
Brief summary
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.
Detailed description
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.
Interventions
DRUGFamotidine
Oral Famotidine
DRUGN-Acetyl cysteine
Oral N-Acetyl Cysteine
Sponsors
Clemson University
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 * performance of a SARS-CoV-2 test within 1 day of enrollment, N.B., must be positive to proceed to treatment phase of the trial
Exclusion criteria
* All patients under 18 * Known allergy to N-Acetyl Cysteine * Known allergy to famotidine or other H2-receptor antagonists * Pregnant or Nursing Mothers * Laboratory Evidence or History of Renal Impairment (eGFR \< 30 mL/min/1.73 m2) * Taking H2-receptor antagonists, hydroxychloroquine or chloroquine. * Patient has been admitted to the hospital prior to study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 | 0 to 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Hospitalization | 0 to 30 days | Number of participants hospitalized |
| Time to Symptom Resolution | 0 to 30 days | Days to resolution of symptoms of infection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Dose N-Acetyl Cysteine Alone N-Acetyl Cysteine 600 mg three times daily
N-Acetyl cysteine: Oral N-Acetyl Cysteine | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Low Dose N-Acetyl Cysteine Alone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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.
Time frame: 0 to 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose N-Acetyl Cysteine Alone | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 | 0 participants |
Secondary
Rate of Hospitalization
Number of participants hospitalized
Time frame: 0 to 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose N-Acetyl Cysteine Alone | Rate of Hospitalization | 0 participants |
Secondary
Time to Symptom Resolution
Days to resolution of symptoms of infection.
Time frame: 0 to 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Dose N-Acetyl Cysteine Alone | Time to Symptom Resolution | 6 days |