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NCT04545008

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

Terminated Phase 1 Results posted Last updated 18 February 2022
What this trial tests

Phase 1 trial testing Famotidine in Covid19 in 2 participants. Terminated before completion.

Timeline
20 October 2020
Primary endpoint
2 June 2021
2 June 2021

Quick facts

Lead sponsorPrisma Health-Upstate
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment2
Start date20 October 2020
Primary completion2 June 2021
Estimated completion2 June 2021
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Prisma Health-Upstate — full company profile →

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

GroupValue95% CI
Low Dose N-Acetyl Cysteine Alone0
Rate of Hospitalization Secondary · 0 to 30 days

Number of participants hospitalized

GroupValue95% CI
Low Dose N-Acetyl Cysteine Alone0
Time to Symptom Resolution Secondary · 0 to 30 days

Days to resolution of symptoms of infection.

GroupValue95% CI
Low Dose N-Acetyl Cysteine Alone66 – 6

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. N-Acetylcysteine to Combat COVID-19: An Evidence Review.
    Shi Z, Puyo CA. · · 2020 · cited 85× · PMID 33177829 · DOI 10.2147/tcrm.s273700
  2. A review of potential suggested drugs for coronavirus disease (COVID-19) treatment.
    Tarighi P, Eftekhari S, Chizari M, Sabernavaei M, et al · · 2021 · cited 80× · PMID 33482181 · DOI 10.1016/j.ejphar.2021.173890
  3. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
    Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
  4. Inflammatory pathways in COVID-19: Mechanism and therapeutic interventions.
    Jiang Y, Zhao T, Zhou X, Xiang Y, et al · · 2022 · cited 44× · PMID 35923762 · DOI 10.1002/mco2.154
  5. Cytokine Storm Syndrome in SARS-CoV-2 Infections: A Functional Role of Mast Cells.
    Hafezi B, Chan L, Knapp JP, Karimi N, et al · · 2021 · cited 41× · PMID 34359931 · DOI 10.3390/cells10071761
  6. A pilot study on intravenous N-Acetylcysteine treatment in patients with mild-to-moderate COVID19-associated acute respiratory distress syndrome.
    Taher A, Lashgari M, Sedighi L, Rahimi-Bashar F, et al · · 2021 · cited 37× · PMID 34114174 · DOI 10.1007/s43440-021-00296-2
  7. Histamine receptors and COVID-19.
    Ennis M, Tiligada K. · · 2021 · cited 36× · PMID 33206207 · DOI 10.1007/s00011-020-01422-1
  8. N-Acetylcysteine as Adjuvant Therapy for COVID-19 - A Perspective on the Current State of the Evidence.
    Wong KK, Lee SWH, Kua KP. · · 2021 · cited 35× · PMID 34262324 · DOI 10.2147/jir.s306849

Verify or expand the search:

Other trials of Famotidine

Trials testing the same drug.

Other recruiting trials for Covid19

Currently open trials in the same condition.

Other Prisma Health-Upstate trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04545008.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing