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Trial - NCT04565392


Column Value
Trial registration number NCT04565392
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Dec. 22, 2021, 3 a.m.
Source : ClinicalTrials.gov

Robert Pyke, MD, PhD

Contact
Last imported at : Dec. 22, 2021, 3 a.m.
Source : ClinicalTrials.gov

pykonsult@gmail.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-09-25

Recruitment status
Last imported at : Dec. 22, 2021, 3 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - probable covid-19 based on presence of at least 5 of the following symptoms of acute onset within the prior 4 days: fever, cough, sore throat, fatigue, episodic chest pain or shortness of breath with exercise, muscle or body aches, headache, loss of smell or taste, stuffy or runny nose, chills or shivering, feeling hot or feverish, nausea, diarrhea - subjects must signify that they have contacted a doctor about their current symptoms. - subject gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations. - subject has acquired a study partner who has agreed to complete the follow-up forms for the subject if the subject unable or has been hospitalized.

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

- constant rather than episodic trouble breathing, persistent pain or pressure in the chest, new confusion, inability to wake or stay awake, bluish lips or face, or any other severe symptom [symptoms cdc urges immediate medical care for]. - known sensitivity or intolerance to famotidine or another acid-blocking drug. - lack of access to the internet at home. - using tizanidine (zanaflex® , a muscle relaxant), dasatinib (sprycel®, a drug for leukemia), cefditoren (pivoxil®, an antibiotic), or fosamprenavir or delavirdine (drugs for hiv) [drug exclusions are per us label for pepcid]. - significant heart or kidney disease in the last 3 months according to subject's primary doctor - pregnant women - taking any investigational medications to treat covid-19, famotidine, anti-viral drugs or corticosteroids and not stopping them within 48 hours before starting study treatment. note: patients are allowed to take over-the-counter agents for temporary relief of symptoms such as antipyretics and analgesics (aspirin, ibuprofen etc), cough remedies, anti-diarrheals, etc.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

drpykessupplements.com

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Dec. 22, 2021, 3 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Clinical Course Binary Outcome;Serious Adverse Events

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "20mg;1", "treatment_id": 503, "treatment_name": "Famotidine", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "20mg;2", "treatment_id": 503, "treatment_name": "Famotidine", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}]