Covid19Phase 1NCT04545008

Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19

A Phase 1 study testing Famotidine and N-Acetyl cysteine in people with Covid19, run by Prisma Health-Upstate at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19
What is being tested?: Famotidine and N-Acetyl cysteine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 3 sitesUnited States
Study dates: 20 Oct 2020to 2 Jun 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Prisma Health Baptist Easley Hospital
Easley, South Carolina, 29640
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Prisma Health Greer Memorial Hospital
Greer, South Carolina, 29650

Other trials in United States

About this study

Official title: A Phase I Clinical Trial of the Combination of Famotidine (FAM) and Oral N-Acetyl Cysteine (NAC) Open Label for Outpatient Treatment of Subjects With Newly Diagnosed SARS-CoV-2 Infection

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.

Read the 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.

Conditions: Covid19
Being tested: Famotidine, N-Acetyl cysteine
Keywords: outpatient, famotidine, n-acetyl cysteine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FamotidineDrug
Also called Pepcid AC
Oral Famotidine
N-Acetyl cysteineDrug
Also called NAC
Oral N-Acetyl Cysteine

Study groups in NCT04545008
Study group	Role	What they receive
Low Dose N-Acetyl Cysteine Alone	Experimental	N-Acetyl Cysteine 600 mg three times daily Receives: Drug: N-Acetyl cysteine
Medium Dose N-Acetyl Cysteine	Experimental	N-Acetyl Cysteine 1,200 mg three times daily Receives: Drug: N-Acetyl cysteine
Low Dose N-Acetyl Cysteine and Low Dose Famotidine	Experimental	N-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily Receives: Drug: Famotidine; Drug: N-Acetyl cysteine
High Dose N-Acetyl Cysteine Alone	Experimental	N-Acetyl Cysteine 1,800 mg three times daily Receives: Drug: N-Acetyl cysteine
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 Receives: Drug: Famotidine; Drug: N-Acetyl cysteine
Low Dose N-Acetyl Cysteine and Medium Dose Famotidine	Experimental	N-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily Receives: Drug: Famotidine; Drug: N-Acetyl cysteine
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 Receives: Drug: Famotidine; Drug: N-Acetyl cysteine
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 Receives: Drug: Famotidine; Drug: N-Acetyl cysteine
Low Dose N-Acetyl Cysteine and High Dose Famotidine	Experimental	N-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily Receives: Drug: Famotidine; Drug: N-Acetyl cysteine
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 Receives: Drug: Famotidine; Drug: N-Acetyl cysteine
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 Receives: Drug: Famotidine; Drug: N-Acetyl cysteine
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 Receives: Drug: Famotidine; Drug: N-Acetyl cysteine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 0 to 30 days

Secondary outcomes (2)

Rate of Hospitalization
Number of participants hospitalized
Measured: 0 to 30 days
Time to Symptom Resolution
Days to resolution of symptoms of infection.
Measured: 0 to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 20202 Jun 2021

First posted10 Sep 2020
Study start20 Oct 2020
Primary completion2 Jun 2021
Study completion2 Jun 2021

Why it stopped: Study was stopped due to poor accrual.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04545008
Sponsor's protocol ID: Pro00100394
Status last verified: Feb 2022
First submitted: 1 Sep 2020
Last updated: 18 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Trial of the Combination of Famotidine (FAM) and Oral N-Acetyl Cysteine (NAC) Open Label for Outpatient Treatment of Subjects With Newly Diagnosed SARS-CoV-2 Infection
ClinicalTrials.gov ID: NCT04545008
Acronym / sponsor ID: Pro00100394
Conditions: Covid19
Keywords: outpatient, famotidine, n-acetyl cysteine
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was stopped due to poor accrual.
Enrolment: 2 participants (actual)
Lead sponsor: Prisma Health-UpstateUniversity, hospital or other
Collaborators: Clemson University
Study start: 20 Oct 2020 (actual)
Primary completion: 2 Jun 2021 (actual)
Study completion: 2 Jun 2021 (actual)
First posted: 10 Sep 2020 (actual)
Results: Posted 18 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
Low Dose N-Acetyl Cysteine Alone	Experimental	Drug: N-Acetyl cysteineN-Acetyl Cysteine 600 mg three times daily
Medium Dose N-Acetyl Cysteine	Experimental	Drug: N-Acetyl cysteineN-Acetyl Cysteine 1,200 mg three times daily
Low Dose N-Acetyl Cysteine and Low Dose Famotidine	Experimental	Drug: Famotidine, Drug: N-Acetyl cysteineN-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily
High Dose N-Acetyl Cysteine Alone	Experimental	Drug: N-Acetyl cysteineN-Acetyl Cysteine 1,800 mg three times daily
Medium Dose N-Acetyl Cysteine and Low Dose Famotidine	Experimental	Drug: Famotidine, Drug: N-Acetyl cysteineN-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily
Low Dose N-Acetyl Cysteine and Medium Dose Famotidine	Experimental	Drug: Famotidine, Drug: N-Acetyl cysteineN-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily
High Dose N-Acetyl Cysteine and Low Dose Famotidine	Experimental	Drug: Famotidine, Drug: N-Acetyl cysteineN-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily
Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine	Experimental	Drug: Famotidine, Drug: N-Acetyl cysteineN-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily
Low Dose N-Acetyl Cysteine and High Dose Famotidine	Experimental	Drug: Famotidine, Drug: N-Acetyl cysteineN-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily
High Dose N-Acetyl Cysteine and Medium Dose Famotidine	Experimental	Drug: Famotidine, Drug: N-Acetyl cysteineN-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily
Medium Dose N-Acetyl Cysteine and High Dose Famotidine	Experimental	Drug: Famotidine, Drug: N-Acetyl cysteineN-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily
High Dose N-Acetyl Cysteine and High Dose Famotidine	Experimental	Drug: Famotidine, Drug: N-Acetyl cysteineN-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FamotidineAlso: Pepcid ACOral Famotidine	Drug	High Dose N-Acetyl Cysteine and High Dose Famotidine, High Dose N-Acetyl Cysteine and Low Dose Famotidine, High Dose N-Acetyl Cysteine and Medium Dose Famotidine, Low Dose N-Acetyl Cysteine and High Dose Famotidine, Low Dose N-Acetyl Cysteine and Low Dose Famotidine, Low Dose N-Acetyl Cysteine and Medium Dose Famotidine, Medium Dose N-Acetyl Cysteine and High Dose Famotidine, Medium Dose N-Acetyl Cysteine and Low Dose Famotidine, Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine
N-Acetyl cysteineAlso: NACOral N-Acetyl Cysteine	Drug	High Dose N-Acetyl Cysteine Alone, High Dose N-Acetyl Cysteine and High Dose Famotidine, High Dose N-Acetyl Cysteine and Low Dose Famotidine, High Dose N-Acetyl Cysteine and Medium Dose Famotidine, Low Dose N-Acetyl Cysteine Alone, Low Dose N-Acetyl Cysteine and High Dose Famotidine, Low Dose N-Acetyl Cysteine and Low Dose Famotidine, Low Dose N-Acetyl Cysteine and Medium Dose Famotidine, Medium Dose N-Acetyl Cysteine, Medium Dose N-Acetyl Cysteine and High Dose Famotidine, Medium Dose N-Acetyl Cysteine and Low Dose Famotidine, Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine

Primary outcome

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Time frame: 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.

2 secondary outcomes

Rate of Hospitalization
Time frame: 0 to 30 days
Time to Symptom Resolution
Time frame: 0 to 30 days

Results and safety

Results posted to the registry on 18 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose N-Acetyl Cysteine Alone	2	2

Primary outcome: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0

Time frame: 0 to 30 days. Number. Unit: participants

Measure	Low Dose N-Acetyl Cysteine Alone n = 2
Value	0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From consent to study completion, an average of 30 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose N-Acetyl Cysteine Alone	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John J O'Connell, M.D. principal investigator

Prisma Health

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Famotidine and N-Acetyl cysteine in people with Covid19, run by Prisma Health-Upstate at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 (time frame: 0 to 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04545008.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.